Trial Outcomes & Findings for To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age. (NCT NCT04955626)
NCT ID: NCT04955626
Last Updated: 2025-11-10
Results Overview
Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 2 were reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
16372 participants
Primary outcome timeframe
Within 5 days after vaccination 2
Results posted on
2025-11-10
Participant Flow
This study was conducted in 6 parts: sub-study A (SSA), sub-study B (SSB), sub-study C (SSC), sub-study D (SSD), sub-study E (SSE) and sub-study F (SSF).
SSA: 10133 participants randomized, 10121 vaccinated and evaluated. SSB: 1487 participants randomized,1485 vaccinated and evaluated. SSC: 140 participants randomized, vaccinated, evaluated. SSD: 1469 participants randomized 1467 vaccinated, 1465vaccinated with 30 mcg BNT162b2 and BNT162b2 OMI and evaluated. SSE: 3020 participants randomized, 3014 vaccinated, 3010 vaccinated with 30 and 60 mcg BNT162b2 and BNT162b2 OMI and evaluated. SSF: 123 participants randomized,122 vaccinated and evaluated.
Participant milestones
| Measure |
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: BNT162b2 30 mcg: Blinded and Open Label Period
Participants received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: Placebo: Blinded Period, Then BNT162b2 30 mcg Open-Label Period
Participants received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly during the Double-Blinded period. Then, they could have received BNT162b2 30 mcg in the Open-Label Period.
|
SSB: BNT162b2 30 mcg Then Placebo
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSC: BNT162b2 10 mcg
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 30 mcg
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 1
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2
Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 2: Group 3
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
|
SSD: Cohort 2: Group 4
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
|
SSD: Cohort 3: Group 5
Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Participants upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blinded Period
STARTED
|
30
|
30
|
30
|
482
|
159
|
321
|
20
|
20
|
20
|
20
|
20
|
20
|
305
|
302
|
307
|
307
|
308
|
313
|
21
|
19
|
21
|
20
|
20
|
21
|
5080
|
5041
|
753
|
732
|
75
|
65
|
216
|
197
|
204
|
315
|
325
|
210
|
|
Blinded Period
Safety Analysis Set
|
30
|
30
|
30
|
482
|
159
|
321
|
20
|
20
|
20
|
20
|
20
|
20
|
305
|
302
|
307
|
307
|
308
|
313
|
21
|
19
|
21
|
20
|
20
|
21
|
5080
|
5041
|
753
|
732
|
75
|
65
|
216
|
197
|
204
|
315
|
323
|
210
|
|
Blinded Period
COMPLETED
|
28
|
30
|
27
|
450
|
151
|
302
|
19
|
19
|
19
|
19
|
20
|
19
|
292
|
294
|
291
|
299
|
294
|
307
|
21
|
19
|
21
|
20
|
20
|
21
|
421
|
22
|
726
|
693
|
69
|
58
|
197
|
183
|
193
|
286
|
293
|
159
|
|
Blinded Period
NOT COMPLETED
|
2
|
0
|
3
|
32
|
8
|
19
|
1
|
1
|
1
|
1
|
0
|
1
|
13
|
8
|
16
|
8
|
14
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
4659
|
5019
|
27
|
39
|
6
|
7
|
19
|
14
|
11
|
29
|
32
|
51
|
|
Open-Label Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4544
|
4906
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Received Open-label BNT162b2 30 mcg
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4544
|
4430
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3272
|
3878
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1272
|
1028
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: BNT162b2 30 mcg: Blinded and Open Label Period
Participants received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: Placebo: Blinded Period, Then BNT162b2 30 mcg Open-Label Period
Participants received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly during the Double-Blinded period. Then, they could have received BNT162b2 30 mcg in the Open-Label Period.
|
SSB: BNT162b2 30 mcg Then Placebo
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSC: BNT162b2 10 mcg
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 30 mcg
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 1
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2
Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 2: Group 3
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
|
SSD: Cohort 2: Group 4
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
|
SSD: Cohort 3: Group 5
Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Participants upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blinded Period
Lost to Follow-up
|
0
|
0
|
0
|
12
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
28
|
7
|
14
|
3
|
2
|
6
|
4
|
5
|
8
|
10
|
32
|
|
Blinded Period
Protocol Violation
|
0
|
0
|
2
|
6
|
4
|
6
|
0
|
1
|
0
|
1
|
0
|
0
|
4
|
6
|
5
|
3
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
14
|
0
|
1
|
2
|
2
|
0
|
0
|
0
|
4
|
6
|
1
|
|
Blinded Period
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
2
|
|
Blinded Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Blinded Period
No longer meets eligibility criteria
|
0
|
0
|
0
|
3
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Blinded Period
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
54
|
3
|
4
|
2
|
0
|
0
|
2
|
2
|
1
|
0
|
1
|
1
|
|
Blinded Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
3
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
5
|
|
Blinded Period
Withdrawal by Subject
|
2
|
0
|
1
|
11
|
2
|
5
|
0
|
0
|
1
|
0
|
0
|
0
|
5
|
1
|
5
|
1
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
62
|
14
|
16
|
1
|
2
|
9
|
5
|
3
|
15
|
11
|
7
|
|
Blinded Period
Refused further study procedures
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Blinded Period
Participants entered open label period
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4544
|
4906
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Period
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Period
Medication error
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Open-Label Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
109
|
41
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
377
|
48
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
No longer meets eligibility criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
621
|
429
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
135
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Refused further study procedures
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Did not receive Open-label BNT162b2 30 mcg
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
476
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
Baseline characteristics by cohort
| Measure |
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=159 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=321 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=30 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=30 Participants
Participants received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=482 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: BNT162b2 30 mcg: Blinded and Open Label Period
n=5080 Participants
Participants received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: Placebo: Blinded Period
n=5041 Participants
Participants received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly.
|
SSB: BNT162b2 30 mcg Then Placebo
n=753 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=732 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSC: BNT162b2 10 mcg
n=75 Participants
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 30 mcg
n=65 Participants
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 1
n=216 Participants
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2
n=197 Participants
Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2b
n=204 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 2: Group 3
n=315 Participants
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
|
SSD: Cohort 2: Group 4
n=323 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.
|
SSD: Cohort 3: Group 5
n=210 Participants
Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Participants upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.
|
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
n=30 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=305 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=302 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=307 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=307 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=308 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=313 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 30 mcg
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
n=21 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
Total
n=16347 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
46 Participants
n=5 Participants
|
44 Participants
n=20 Participants
|
233 Participants
n=40 Participants
|
228 Participants
n=28 Participants
|
75 Participants
n=46 Participants
|
65 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
691 Participants
n=16347 Participants
|
|
Age, Customized
Adults (18-64 years)
|
159 Participants
n=6 Participants
|
321 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=116 Participants
|
5 Participants
n=19 Participants
|
7 Participants
n=8 Participants
|
30 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
482 Participants
n=6 Participants
|
3859 Participants
n=5 Participants
|
3811 Participants
n=20 Participants
|
520 Participants
n=40 Participants
|
504 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
216 Participants
n=22 Participants
|
197 Participants
n=226 Participants
|
204 Participants
n=3 Participants
|
315 Participants
n=6 Participants
|
323 Participants
n=6 Participants
|
210 Participants
n=6 Participants
|
30 Participants
n=12 Participants
|
5 Participants
n=103 Participants
|
9 Participants
n=386 Participants
|
126 Participants
n=6 Participants
|
105 Participants
n=14 Participants
|
121 Participants
n=17 Participants
|
123 Participants
n=15 Participants
|
112 Participants
n=17 Participants
|
109 Participants
n=16 Participants
|
6 Participants
n=252 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=269 Participants
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
9 Participants
n=21 Participants
|
11989 Participants
n=16347 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
15 Participants
n=116 Participants
|
15 Participants
n=19 Participants
|
13 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1166 Participants
n=5 Participants
|
1174 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
15 Participants
n=103 Participants
|
10 Participants
n=386 Participants
|
176 Participants
n=6 Participants
|
196 Participants
n=14 Participants
|
186 Participants
n=17 Participants
|
183 Participants
n=15 Participants
|
194 Participants
n=17 Participants
|
199 Participants
n=16 Participants
|
15 Participants
n=252 Participants
|
12 Participants
n=8 Participants
|
15 Participants
n=269 Participants
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
12 Participants
n=21 Participants
|
3633 Participants
n=16347 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=103 Participants
|
1 Participants
n=386 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
34 Participants
n=16347 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=6 Participants
|
180 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=116 Participants
|
14 Participants
n=19 Participants
|
12 Participants
n=8 Participants
|
17 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
269 Participants
n=6 Participants
|
2624 Participants
n=5 Participants
|
2526 Participants
n=20 Participants
|
434 Participants
n=40 Participants
|
447 Participants
n=28 Participants
|
37 Participants
n=46 Participants
|
33 Participants
n=34 Participants
|
137 Participants
n=22 Participants
|
119 Participants
n=226 Participants
|
121 Participants
n=3 Participants
|
152 Participants
n=6 Participants
|
156 Participants
n=6 Participants
|
106 Participants
n=6 Participants
|
14 Participants
n=12 Participants
|
7 Participants
n=103 Participants
|
11 Participants
n=386 Participants
|
160 Participants
n=6 Participants
|
157 Participants
n=14 Participants
|
153 Participants
n=17 Participants
|
154 Participants
n=15 Participants
|
144 Participants
n=17 Participants
|
162 Participants
n=16 Participants
|
9 Participants
n=252 Participants
|
9 Participants
n=8 Participants
|
13 Participants
n=269 Participants
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
12 Participants
n=21 Participants
|
8528 Participants
n=16347 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=6 Participants
|
141 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
11 Participants
n=116 Participants
|
6 Participants
n=19 Participants
|
8 Participants
n=8 Participants
|
13 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
213 Participants
n=6 Participants
|
2456 Participants
n=5 Participants
|
2515 Participants
n=20 Participants
|
319 Participants
n=40 Participants
|
285 Participants
n=28 Participants
|
38 Participants
n=46 Participants
|
32 Participants
n=34 Participants
|
79 Participants
n=22 Participants
|
78 Participants
n=226 Participants
|
83 Participants
n=3 Participants
|
163 Participants
n=6 Participants
|
167 Participants
n=6 Participants
|
104 Participants
n=6 Participants
|
16 Participants
n=12 Participants
|
13 Participants
n=103 Participants
|
9 Participants
n=386 Participants
|
145 Participants
n=6 Participants
|
145 Participants
n=14 Participants
|
154 Participants
n=17 Participants
|
153 Participants
n=15 Participants
|
164 Participants
n=17 Participants
|
151 Participants
n=16 Participants
|
12 Participants
n=252 Participants
|
10 Participants
n=8 Participants
|
8 Participants
n=269 Participants
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
9 Participants
n=21 Participants
|
7819 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
White
|
124 Participants
n=6 Participants
|
250 Participants
n=6 Participants
|
16 Participants
n=6 Participants
|
19 Participants
n=116 Participants
|
15 Participants
n=19 Participants
|
17 Participants
n=8 Participants
|
24 Participants
n=6 Participants
|
26 Participants
n=6 Participants
|
389 Participants
n=6 Participants
|
3998 Participants
n=5 Participants
|
4002 Participants
n=20 Participants
|
491 Participants
n=40 Participants
|
493 Participants
n=28 Participants
|
55 Participants
n=46 Participants
|
50 Participants
n=34 Participants
|
16 Participants
n=22 Participants
|
8 Participants
n=226 Participants
|
9 Participants
n=3 Participants
|
237 Participants
n=6 Participants
|
224 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
25 Participants
n=12 Participants
|
14 Participants
n=103 Participants
|
16 Participants
n=386 Participants
|
268 Participants
n=6 Participants
|
254 Participants
n=14 Participants
|
261 Participants
n=17 Participants
|
262 Participants
n=15 Participants
|
277 Participants
n=17 Participants
|
272 Participants
n=16 Participants
|
21 Participants
n=252 Participants
|
19 Participants
n=8 Participants
|
21 Participants
n=269 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
12265 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
470 Participants
n=5 Participants
|
457 Participants
n=20 Participants
|
159 Participants
n=40 Participants
|
155 Participants
n=28 Participants
|
11 Participants
n=46 Participants
|
9 Participants
n=34 Participants
|
176 Participants
n=22 Participants
|
172 Participants
n=226 Participants
|
178 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
155 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=103 Participants
|
1 Participants
n=386 Participants
|
19 Participants
n=6 Participants
|
22 Participants
n=14 Participants
|
23 Participants
n=17 Participants
|
20 Participants
n=15 Participants
|
13 Participants
n=17 Participants
|
19 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
2203 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
86 Participants
n=5 Participants
|
92 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
206 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=6 Participants
|
25 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=116 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
288 Participants
n=5 Participants
|
269 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
58 Participants
n=28 Participants
|
7 Participants
n=46 Participants
|
5 Participants
n=34 Participants
|
4 Participants
n=22 Participants
|
2 Participants
n=226 Participants
|
1 Participants
n=3 Participants
|
42 Participants
n=6 Participants
|
45 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=103 Participants
|
3 Participants
n=386 Participants
|
13 Participants
n=6 Participants
|
20 Participants
n=14 Participants
|
16 Participants
n=17 Participants
|
20 Participants
n=15 Participants
|
16 Participants
n=17 Participants
|
17 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
994 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=386 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
34 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
5 Participants
n=28 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
41 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
2 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
209 Participants
n=5 Participants
|
197 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
12 Participants
n=28 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
10 Participants
n=22 Participants
|
11 Participants
n=226 Participants
|
6 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
22 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=386 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=14 Participants
|
6 Participants
n=17 Participants
|
3 Participants
n=15 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
559 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
17 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=116 Participants
|
4 Participants
n=19 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
66 Participants
n=6 Participants
|
759 Participants
n=5 Participants
|
750 Participants
n=20 Participants
|
152 Participants
n=40 Participants
|
150 Participants
n=28 Participants
|
15 Participants
n=46 Participants
|
11 Participants
n=34 Participants
|
6 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
4 Participants
n=3 Participants
|
48 Participants
n=6 Participants
|
46 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=103 Participants
|
4 Participants
n=386 Participants
|
57 Participants
n=6 Participants
|
38 Participants
n=14 Participants
|
44 Participants
n=17 Participants
|
46 Participants
n=15 Participants
|
45 Participants
n=17 Participants
|
44 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
2369 Participants
n=16347 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/non-Latino
|
142 Participants
n=6 Participants
|
282 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=116 Participants
|
16 Participants
n=19 Participants
|
17 Participants
n=8 Participants
|
26 Participants
n=6 Participants
|
27 Participants
n=6 Participants
|
413 Participants
n=6 Participants
|
4309 Participants
n=5 Participants
|
4283 Participants
n=20 Participants
|
595 Participants
n=40 Participants
|
577 Participants
n=28 Participants
|
59 Participants
n=46 Participants
|
53 Participants
n=34 Participants
|
209 Participants
n=22 Participants
|
196 Participants
n=226 Participants
|
200 Participants
n=3 Participants
|
266 Participants
n=6 Participants
|
277 Participants
n=6 Participants
|
202 Participants
n=6 Participants
|
27 Participants
n=12 Participants
|
18 Participants
n=103 Participants
|
16 Participants
n=386 Participants
|
248 Participants
n=6 Participants
|
264 Participants
n=14 Participants
|
263 Participants
n=17 Participants
|
261 Participants
n=15 Participants
|
263 Participants
n=17 Participants
|
269 Participants
n=16 Participants
|
21 Participants
n=252 Participants
|
19 Participants
n=8 Participants
|
21 Participants
n=269 Participants
|
20 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
13937 Participants
n=16347 Participants
|
PRIMARY outcome
Timeframe: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year [PY]) for BNT162b2 was 0.823 and for Placebo was 0.792Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. Human Immunodeficiency Virus (HIV) positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Occurrences (number of cases) of first COVID-19 infection in participants after booster dose per 1000 person-year, without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4659 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4614 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population
|
7.290 Number of first Covid-19 cases/1000 PY
|
155.303 Number of first Covid-19 cases/1000 PY
|
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PRIMARY outcome
Timeframe: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 0.871 and for Placebo was 0.835Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of Subjects Analyzed' signifies participants evaluable for this outcome measure.
Occurrences (number of cases) of first COVID-19 infection in participants after booster dose with and without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4934 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4863 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population
|
8.037 Number of first Covid-19 cases/1000 PY
|
148.503 Number of first Covid-19 cases/1000 PY
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PRIMARY outcome
Timeframe: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.098 and for Placebo was 0.932Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of participants Analyzed' signifies participants evaluable for this outcome measure.
Occurrences (number of cases) of first COVID-19 infection in participants after booster dose without past SARS-CoV-2 infection at final analysis were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4639 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4601 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population
|
57.377 Number of first Covid-19 cases/1000 PY
|
158.798 Number of first Covid-19 cases/1000 PY
|
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PRIMARY outcome
Timeframe: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.173 and for Placebo was 0.989Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of participants Analyzed' signifies participants evaluable for this outcome measure.
Occurrences (number of cases) of first COVID-19 infection in participants after booster dose with and without past SARS-CoV-2 infection at final analysis were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4903 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4846 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population
|
57.118 Number of first Covid-19 cases/1000 PY
|
151.668 Number of first Covid-19 cases/1000 PY
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PRIMARY outcome
Timeframe: From booster dose (Day 1) to 1 month after booster dosePopulation: Safety population included all randomized participants who received at least 1 dose of the study intervention. HIV positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=5054 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=5016 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Reporting Adverse Events
|
26.3 Percentage of participants
Interval 25.0 to 27.5
|
7.1 Percentage of participants
Interval 6.4 to 7.8
|
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PRIMARY outcome
Timeframe: BNT162b2 30 mcg, Placebo then BNT162b2 30 mcg: From BNT162b2 dose to 6 months after BNT162b2 dose; Placebo: From placebo dose to unblinding for original placebo participants. Median blinded follow-up period for Placebo group=2.8 monthsPopulation: Safety population included all randomized participants who received at least 1 dose of the study intervention. HIV positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=5054 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=5016 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=4405 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)
|
1.4 Percentage of participants
Interval 1.1 to 1.8
|
0.8 Percentage of participants
Interval 0.6 to 1.1
|
1.0 Percentage of participants
Interval 0.7 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 (Vaccination 1)Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants with elevated troponin I levels before administration of Vaccination 1 were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=751 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=730 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1
|
0.7 Percentage of participants
Interval 0.2 to 1.5
|
0.5 Percentage of participants
Interval 0.1 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 1 were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=719 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=693 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1
|
1.0 Percentage of participants
Interval 0.4 to 2.0
|
0.6 Percentage of participants
Interval 0.2 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-Vaccination 2 (1 month after Vaccination 1)Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants with elevated troponin I levels pre vaccination 2 were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=628 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=600 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1)
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
0.3 Percentage of participants
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.
Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 2 were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=667 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=634 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2
|
1.5 Percentage of participants
Interval 0.7 to 2.7
|
0.3 Percentage of participants
Interval 0.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.
Percentage of participants with elevated troponin I levels within 1 month after administration of Vaccination 2 were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=676 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=645 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2
|
0.7 Percentage of participants
Interval 0.2 to 1.7
|
0.3 Percentage of participants
Interval 0.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 1Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=747 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=728 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Any
|
5.8 Percentage of participants
Interval 4.2 to 7.7
|
0.5 Percentage of participants
Interval 0.1 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
4.4 Percentage of participants
Interval 3.1 to 6.1
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
1.1 Percentage of participants
Interval 0.5 to 2.1
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Any
|
6.6 Percentage of participants
Interval 4.9 to 8.6
|
0.5 Percentage of participants
Interval 0.1 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
5.0 Percentage of participants
Interval 3.5 to 6.8
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
1.5 Percentage of participants
Interval 0.7 to 2.6
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Any
|
74.4 Percentage of participants
Interval 71.1 to 77.5
|
13.9 Percentage of participants
Interval 11.4 to 16.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Mild
|
48.7 Percentage of participants
Interval 45.1 to 52.4
|
12.2 Percentage of participants
Interval 9.9 to 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Moderate
|
25.4 Percentage of participants
Interval 22.3 to 28.7
|
1.6 Percentage of participants
Interval 0.9 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 2Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=706 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=672 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Any
|
0.7 Percentage of participants
Interval 0.2 to 1.6
|
4.6 Percentage of participants
Interval 3.2 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
2.8 Percentage of participants
Interval 1.7 to 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
1.5 Percentage of participants
Interval 0.7 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0.3 Percentage of participants
Interval 0.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Any
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
5.5 Percentage of participants
Interval 3.9 to 7.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
3.4 Percentage of participants
Interval 2.2 to 5.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 0.5
|
1.9 Percentage of participants
Interval 1.0 to 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Any
|
8.8 Percentage of participants
Interval 6.8 to 11.1
|
71.7 Percentage of participants
Interval 68.2 to 75.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Mild
|
6.7 Percentage of participants
Interval 4.9 to 8.8
|
40.3 Percentage of participants
Interval 36.6 to 44.1
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Moderate
|
2.1 Percentage of participants
Interval 1.2 to 3.5
|
30.5 Percentage of participants
Interval 27.0 to 34.1
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0.9 Percentage of participants
Interval 0.3 to 1.9
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 1Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure.
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=747 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=728 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38 deg C
|
6.0 Percentage of participants
Interval 4.4 to 8.0
|
1.9 Percentage of participants
Interval 1.1 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: 38.0 to 38.4 deg C
|
4.1 Percentage of participants
Interval 2.8 to 5.8
|
1.4 Percentage of participants
Interval 0.7 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.4 to 38.9 deg C
|
1.7 Percentage of participants
Interval 0.9 to 3.0
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.9 to 40.0 deg C
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Any
|
54.2 Percentage of participants
Interval 50.6 to 57.8
|
31.9 Percentage of participants
Interval 28.5 to 35.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Mild
|
27.4 Percentage of participants
Interval 24.3 to 30.8
|
19.5 Percentage of participants
Interval 16.7 to 22.6
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Moderate
|
25.3 Percentage of participants
Interval 22.2 to 28.6
|
12.2 Percentage of participants
Interval 9.9 to 14.8
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Severe
|
1.5 Percentage of participants
Interval 0.7 to 2.6
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Any
|
42.6 Percentage of participants
Interval 39.0 to 46.2
|
28.3 Percentage of participants
Interval 25.0 to 31.7
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Mild
|
24.2 Percentage of participants
Interval 21.2 to 27.5
|
18.0 Percentage of participants
Interval 15.3 to 21.0
|
—
|
—
|
—
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—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Moderate
|
17.3 Percentage of participants
Interval 14.6 to 20.2
|
10.0 Percentage of participants
Interval 7.9 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Severe
|
1.1 Percentage of participants
Interval 0.5 to 2.1
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Any
|
17.1 Percentage of participants
Interval 14.5 to 20.0
|
5.9 Percentage of participants
Interval 4.3 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Mild
|
10.6 Percentage of participants
Interval 8.5 to 13.0
|
4.4 Percentage of participants
Interval 3.0 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Moderate
|
6.3 Percentage of participants
Interval 4.7 to 8.3
|
1.5 Percentage of participants
Interval 0.8 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Any
|
3.2 Percentage of participants
Interval 2.1 to 4.7
|
0.8 Percentage of participants
Interval 0.3 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Mild
|
2.8 Percentage of participants
Interval 1.7 to 4.3
|
0.7 Percentage of participants
Interval 0.2 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Moderate
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Any
|
7.4 Percentage of participants
Interval 5.6 to 9.5
|
7.4 Percentage of participants
Interval 5.6 to 9.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Mild
|
6.4 Percentage of participants
Interval 4.8 to 8.4
|
6.0 Percentage of participants
Interval 4.4 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Moderate
|
0.9 Percentage of participants
Interval 0.4 to 1.9
|
1.4 Percentage of participants
Interval 0.7 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Any
|
27.6 Percentage of participants
Interval 24.4 to 30.9
|
7.7 Percentage of participants
Interval 5.9 to 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Mild
|
14.1 Percentage of participants
Interval 11.6 to 16.8
|
5.1 Percentage of participants
Interval 3.6 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Moderate
|
13.3 Percentage of participants
Interval 10.9 to 15.9
|
2.5 Percentage of participants
Interval 1.5 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Any
|
12.9 Percentage of participants
Interval 10.5 to 15.5
|
4.5 Percentage of participants
Interval 3.1 to 6.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Mild
|
8.3 Percentage of participants
Interval 6.4 to 10.5
|
3.0 Percentage of participants
Interval 1.9 to 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Moderate
|
4.3 Percentage of participants
Interval 2.9 to 6.0
|
1.5 Percentage of participants
Interval 0.8 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 2Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=706 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=672 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >=38 deg C
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
4.3 Percentage of participants
Interval 2.9 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: 38.0 to 38.4 deg C
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
2.5 Percentage of participants
Interval 1.5 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >38.4 to 38.9 deg C
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
1.3 Percentage of participants
Interval 0.6 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >38.9 to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0.4 Percentage of participants
Interval 0.1 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Any
|
17.6 Percentage of participants
Interval 14.8 to 20.6
|
47.3 Percentage of participants
Interval 43.5 to 51.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Mild
|
8.6 Percentage of participants
Interval 6.7 to 11.0
|
18.8 Percentage of participants
Interval 15.9 to 21.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Moderate
|
8.5 Percentage of participants
Interval 6.5 to 10.8
|
27.1 Percentage of participants
Interval 23.8 to 30.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Severe
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
1.5 Percentage of participants
Interval 0.7 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Any
|
17.8 Percentage of participants
Interval 15.1 to 20.9
|
39.7 Percentage of participants
Interval 36.0 to 43.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Mild
|
10.3 Percentage of participants
Interval 8.2 to 12.8
|
19.8 Percentage of participants
Interval 16.8 to 23.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Moderate
|
7.2 Percentage of participants
Interval 5.4 to 9.4
|
19.0 Percentage of participants
Interval 16.1 to 22.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0.9 Percentage of participants
Interval 0.3 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Any
|
3.7 Percentage of participants
Interval 2.4 to 5.3
|
22.3 Percentage of participants
Interval 19.2 to 25.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Mild
|
2.3 Percentage of participants
Interval 1.3 to 3.7
|
13.2 Percentage of participants
Interval 10.8 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Moderate
|
1.1 Percentage of participants
Interval 0.5 to 2.2
|
8.8 Percentage of participants
Interval 6.8 to 11.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Severe
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0.3 Percentage of participants
Interval 0.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Any
|
1.0 Percentage of participants
Interval 0.4 to 2.0
|
1.9 Percentage of participants
Interval 1.0 to 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Mild
|
0.7 Percentage of participants
Interval 0.2 to 1.6
|
1.8 Percentage of participants
Interval 0.9 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Moderate
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Any
|
3.3 Percentage of participants
Interval 2.1 to 4.8
|
8.0 Percentage of participants
Interval 6.1 to 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Mild
|
2.1 Percentage of participants
Interval 1.2 to 3.5
|
6.5 Percentage of participants
Interval 4.8 to 8.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Moderate
|
1.1 Percentage of participants
Interval 0.5 to 2.2
|
1.5 Percentage of participants
Interval 0.7 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Any
|
4.5 Percentage of participants
Interval 3.1 to 6.3
|
29.2 Percentage of participants
Interval 25.8 to 32.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Mild
|
2.3 Percentage of participants
Interval 1.3 to 3.7
|
15.9 Percentage of participants
Interval 13.2 to 18.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Moderate
|
2.1 Percentage of participants
Interval 1.2 to 3.5
|
12.9 Percentage of participants
Interval 10.5 to 15.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Severe
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
0.3 Percentage of participants
Interval 0.0 to 1.1
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Any
|
3.1 Percentage of participants
Interval 2.0 to 4.7
|
12.2 Percentage of participants
Interval 9.8 to 14.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Mild
|
1.6 Percentage of participants
Interval 0.8 to 2.8
|
7.4 Percentage of participants
Interval 5.6 to 9.7
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Moderate
|
1.6 Percentage of participants
Interval 0.8 to 2.8
|
4.8 Percentage of participants
Interval 3.3 to 6.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
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—
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—
|
—
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—
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—
|
—
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—
|
—
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—
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—
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—
|
—
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—
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Vaccination 1 up to 1 Month After Vaccination 1Population: Safety population included all participant who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=753 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=732 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1
|
9.4 Percentage of participants
Interval 7.4 to 11.7
|
10.4 Percentage of participants
Interval 8.3 to 12.8
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Vaccination 2 up to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Participants who did not receive Vaccination 2 or who received an incorrect vaccine at Vaccination 2 were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=731 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=700 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2
|
5.6 Percentage of participants
Interval 4.1 to 7.5
|
7.4 Percentage of participants
Interval 5.6 to 9.6
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Vaccination 1 up to 1 month after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=753 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=732 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Vaccination 2 up to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for the specified outcome measure and received two doses of study vaccination for SSB.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=731 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=700 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2
|
0 Percentage of participants
Interval 0.0 to 0.5
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after the booster dosePopulation: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 cm and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after the booster (third) dose and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=75 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=64 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Redness: Any
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
6.3 Percentage of participants
Interval 1.7 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Redness: Mild
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
4.7 Percentage of participants
Interval 1.0 to 13.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 4.8
|
1.6 Percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Swelling: Any
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
9.4 Percentage of participants
Interval 3.5 to 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Swelling: Mild
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
6.3 Percentage of participants
Interval 1.7 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 4.8
|
3.1 Percentage of participants
Interval 0.4 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Pain at the injection site: Any
|
56.0 Percentage of participants
Interval 44.1 to 67.5
|
78.1 Percentage of participants
Interval 66.0 to 87.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Pain at the injection site: Mild
|
40.0 Percentage of participants
Interval 28.9 to 52.0
|
46.9 Percentage of participants
Interval 34.3 to 59.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Pain at the injection site: Moderate
|
16.0 Percentage of participants
Interval 8.6 to 26.3
|
31.3 Percentage of participants
Interval 20.2 to 44.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after the booster dosePopulation: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure.
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24 h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=75 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=64 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened muscle pain: Mild
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
20.3 Percentage of participants
Interval 11.3 to 32.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened muscle pain: Moderate
|
20.0 Percentage of participants
Interval 11.6 to 30.8
|
17.2 Percentage of participants
Interval 8.9 to 28.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Diarrhea: Any
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
9.4 Percentage of participants
Interval 3.5 to 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Diarrhea: Mild
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
9.4 Percentage of participants
Interval 3.5 to 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Diarrhea: Moderate
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fever: >=38.0 deg C
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
6.3 Percentage of participants
Interval 1.7 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fever: >=38.0°C to 38.4 deg C
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
3.1 Percentage of participants
Interval 0.4 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fever: >38.4°C to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 4.8
|
1.6 Percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fever: >38.9°C to 40.0 deg C
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 4.8
|
1.6 Percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fatigue: Any
|
49.3 Percentage of participants
Interval 37.6 to 61.1
|
54.7 Percentage of participants
Interval 41.7 to 67.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fatigue: Mild
|
22.7 Percentage of participants
Interval 13.8 to 33.8
|
25.0 Percentage of participants
Interval 15.0 to 37.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fatigue: Moderate
|
25.3 Percentage of participants
Interval 16.0 to 36.7
|
26.6 Percentage of participants
Interval 16.3 to 39.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fatigue: Severe
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
3.1 Percentage of participants
Interval 0.4 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Headache: Any
|
41.3 Percentage of participants
Interval 30.1 to 53.3
|
53.1 Percentage of participants
Interval 40.2 to 65.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Headache: Mild
|
21.3 Percentage of participants
Interval 12.7 to 32.3
|
31.3 Percentage of participants
Interval 20.2 to 44.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Headache: Moderate
|
20.0 Percentage of participants
Interval 11.6 to 30.8
|
20.3 Percentage of participants
Interval 11.3 to 32.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
1.6 Percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Chills: Any
|
13.3 Percentage of participants
Interval 6.6 to 23.2
|
23.4 Percentage of participants
Interval 13.8 to 35.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Chills: Mild
|
5.3 Percentage of participants
Interval 1.5 to 13.1
|
12.5 Percentage of participants
Interval 5.6 to 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Chills: Moderate
|
8.0 Percentage of participants
Interval 3.0 to 16.6
|
10.9 Percentage of participants
Interval 4.5 to 21.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Vomiting: Any
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
3.1 Percentage of participants
Interval 0.4 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 4.8
|
1.6 Percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Vomiting: Moderate
|
1.3 Percentage of participants
Interval 0.0 to 7.2
|
1.6 Percentage of participants
Interval 0.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened muscle pain: Any
|
24.0 Percentage of participants
Interval 14.9 to 35.3
|
37.5 Percentage of participants
Interval 25.7 to 50.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened joint pain: Any
|
14.7 Percentage of participants
Interval 7.6 to 24.7
|
15.6 Percentage of participants
Interval 7.8 to 26.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened joint pain: Mild
|
5.3 Percentage of participants
Interval 1.5 to 13.1
|
10.9 Percentage of participants
Interval 4.5 to 21.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened joint pain: Moderate
|
9.3 Percentage of participants
Interval 3.8 to 18.3
|
4.7 Percentage of participants
Interval 1.0 to 13.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From booster dose (Day 1) up to 1 month after booster dosePopulation: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from booster (third) dose up to 1 month after booster (third) dose were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=75 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=65 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
7.7 Percentage of participants
Interval 2.5 to 17.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From booster dose (Day 1) up to 6 months after booster dosePopulation: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=75 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=65 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose
|
0 Percentage of participants
Interval 0.0 to 4.8
|
1.5 Percentage of participants
Interval 0.0 to 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (pre-dose)Population: Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they are randomized, have valid and determinate immunogenicity result for Visit 303 (1 month after booster dose), have blood sample collected within an appropriate window (within 28-42 days after booster dose), and have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
GMT of SARS-CoV-2 reference-strain-neutralizing titers at baseline (before the booster dose) was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=65 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=54 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline
|
1337.2 Titer
Interval 941.5 to 1899.2
|
1648.4 Titer
Interval 1087.5 to 2498.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the booster dosePopulation: Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they are randomized, have valid and determinate immunogenicity result for Visit 303 (1 month after booster dose), have blood sample collected within an appropriate window (within 28-42 days after booster dose), and have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
GMT of SARS-CoV-2 reference-strain-neutralizing titers at 1 month after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=67 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=54 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose
|
11672.4 Titer
Interval 9754.8 to 13967.0
|
15680.7 Titer
Interval 13308.9 to 18475.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline to 1 month after the booster dosePopulation: Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they are randomized, have valid and determinate immunogenicity result for Visit 303 (1 month after booster dose), have blood sample collected within an appropriate window (within 28-42 days after booster dose), and have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline to 1 month after the booster dose received in this sub-study was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=65 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=54 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose
|
8.6 Fold rise
Interval 6.4 to 11.6
|
9.5 Fold rise
Interval 6.5 to 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after the booster dosePopulation: Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they are randomized, have valid and determinate immunogenicity result for Visit 303 (1 month after booster dose), have blood sample collected within an appropriate window (within 28-42 days after booster dose), and have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month after the booster dose was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=65 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=54 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose
|
67.7 Percentage of participants
Interval 54.9 to 78.8
|
66.7 Percentage of participants
Interval 52.5 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
|
—
|
—
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—
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—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 1Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 1 and 'Number Analyzed (n)' signifies participants evaluable for specified rows.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection (inj) site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit/hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=207 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=192 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=201 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=294 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=304 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=188 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
4.3 Percentage of participants
Interval 2.0 to 8.1
|
4.2 Percentage of participants
Interval 1.8 to 8.0
|
4.5 Percentage of participants
Interval 2.1 to 8.3
|
5.4 Percentage of participants
Interval 3.1 to 8.7
|
6.9 Percentage of participants
Interval 4.3 to 10.4
|
6.5 Percentage of participants
Interval 3.4 to 11.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
3.9 Percentage of participants
Interval 1.7 to 7.5
|
2.6 Percentage of participants
Interval 0.9 to 6.0
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
3.1 Percentage of participants
Interval 1.4 to 5.7
|
2.0 Percentage of participants
Interval 0.7 to 4.2
|
4.8 Percentage of participants
Interval 2.2 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Injection site pain: Any
|
46.4 Percentage of participants
Interval 39.4 to 53.4
|
42.7 Percentage of participants
Interval 35.6 to 50.0
|
42.3 Percentage of participants
Interval 35.4 to 49.4
|
78.2 Percentage of participants
Interval 73.1 to 82.8
|
78.9 Percentage of participants
Interval 73.9 to 83.4
|
54.3 Percentage of participants
Interval 46.8 to 61.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Injection site pain: Mild
|
30.9 Percentage of participants
Interval 24.7 to 37.7
|
27.1 Percentage of participants
Interval 20.9 to 34.0
|
32.3 Percentage of participants
Interval 25.9 to 39.3
|
59.2 Percentage of participants
Interval 53.3 to 64.9
|
61.5 Percentage of participants
Interval 55.8 to 67.0
|
27.7 Percentage of participants
Interval 21.4 to 34.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Any
|
3.4 Percentage of participants
Interval 1.4 to 6.8
|
5.7 Percentage of participants
Interval 2.9 to 10.0
|
2.5 Percentage of participants
Interval 0.8 to 5.7
|
7.1 Percentage of participants
Interval 4.5 to 10.7
|
4.3 Percentage of participants
Interval 2.3 to 7.2
|
5.4 Percentage of participants
Interval 2.6 to 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
4.2 Percentage of participants
Interval 1.8 to 8.0
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
4.4 Percentage of participants
Interval 2.4 to 7.4
|
3.9 Percentage of participants
Interval 2.1 to 6.8
|
3.2 Percentage of participants
Interval 1.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
1.4 Percentage of participants
Interval 0.3 to 4.2
|
1.6 Percentage of participants
Interval 0.3 to 4.5
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
2.7 Percentage of participants
Interval 1.2 to 5.3
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
2.2 Percentage of participants
Interval 0.6 to 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Any
|
8.2 Percentage of participants
Interval 4.9 to 12.8
|
7.3 Percentage of participants
Interval 4.0 to 11.9
|
5.5 Percentage of participants
Interval 2.8 to 9.6
|
8.5 Percentage of participants
Interval 5.6 to 12.3
|
8.9 Percentage of participants
Interval 5.9 to 12.7
|
11.3 Percentage of participants
Interval 7.1 to 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Injection site pain: Moderate
|
15.0 Percentage of participants
Interval 10.4 to 20.6
|
14.1 Percentage of participants
Interval 9.5 to 19.8
|
9.5 Percentage of participants
Interval 5.8 to 14.4
|
18.4 Percentage of participants
Interval 14.1 to 23.3
|
16.4 Percentage of participants
Interval 12.5 to 21.1
|
26.1 Percentage of participants
Interval 19.9 to 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Injection site pain: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
1.6 Percentage of participants
Interval 0.3 to 4.5
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Injection site pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 2Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 2 and 'Number Analyzed (n)' signifies participants evaluable for specified rows and received two doses of study vaccination for SSD. Participants of SSD: Cohort 1: Group 1 did not receive Vaccination 2 and therefore were not analyzed for this outcome measure.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=157 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=196 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=218 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=142 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
1.5 Percentage of participants
Interval 0.3 to 4.4
|
0 Percentage of participants
Interval 0.0 to 1.7
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Any
|
8.9 Percentage of participants
Interval 5.0 to 14.5
|
4.1 Percentage of participants
Interval 1.8 to 7.9
|
6.5 Percentage of participants
Interval 3.6 to 10.6
|
9.2 Percentage of participants
Interval 5.0 to 15.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Injection site pain: Any
|
40.1 Percentage of participants
Interval 32.4 to 48.2
|
74.5 Percentage of participants
Interval 67.8 to 80.4
|
70.6 Percentage of participants
Interval 64.1 to 76.6
|
34.5 Percentage of participants
Interval 26.7 to 42.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Injection site pain: Mild
|
29.9 Percentage of participants
Interval 22.9 to 37.8
|
55.6 Percentage of participants
Interval 48.4 to 62.7
|
57.8 Percentage of participants
Interval 50.9 to 64.4
|
21.1 Percentage of participants
Interval 14.7 to 28.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Injection site pain: Moderate
|
10.2 Percentage of participants
Interval 5.9 to 16.0
|
18.9 Percentage of participants
Interval 13.7 to 25.1
|
12.4 Percentage of participants
Interval 8.3 to 17.5
|
13.4 Percentage of participants
Interval 8.3 to 20.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Injection site pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0.5 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Injection site pain
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Any
|
5.7 Percentage of participants
Interval 2.7 to 10.6
|
5.1 Percentage of participants
Interval 2.5 to 9.2
|
4.1 Percentage of participants
Interval 1.9 to 7.7
|
4.3 Percentage of participants
Interval 1.6 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
4.5 Percentage of participants
Interval 1.8 to 9.0
|
3.6 Percentage of participants
Interval 1.4 to 7.2
|
4.1 Percentage of participants
Interval 1.9 to 7.7
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
7.0 Percentage of participants
Interval 3.5 to 12.2
|
2.0 Percentage of participants
Interval 0.6 to 5.1
|
5.5 Percentage of participants
Interval 2.9 to 9.5
|
5.7 Percentage of participants
Interval 2.5 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
2.0 Percentage of participants
Interval 0.6 to 5.1
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
3.5 Percentage of participants
Interval 1.2 to 8.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 3Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 3. Participants of SSD: Cohort 1: Group 1, Group 2 and SSD Cohort 2: Group 3, Group 4 did not receive Vaccination 3 and therefore were not analyzed for this outcome measure.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 3 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=154 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Moderate
|
3.2 Percentage of participants
Interval 1.1 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Any
|
10.4 Percentage of participants
Interval 6.1 to 16.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Any
|
39.0 Percentage of participants
Interval 31.2 to 47.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Mild
|
19.5 Percentage of participants
Interval 13.5 to 26.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Any
|
4.5 Percentage of participants
Interval 1.8 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Redness: Mild
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Mild
|
3.2 Percentage of participants
Interval 1.1 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Swelling: Moderate
|
7.1 Percentage of participants
Interval 3.6 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Pain at the injection site: Moderate
|
18.8 Percentage of participants
Interval 13.0 to 25.9
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 1Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 1.
Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C, categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=207 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=192 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=201 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=294 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=304 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=186 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: Any
|
5.8 Percentage of participants
Interval 3.0 to 9.9
|
2.6 Percentage of participants
Interval 0.9 to 6.0
|
5.0 Percentage of participants
Interval 2.4 to 9.0
|
8.8 Percentage of participants
Interval 5.9 to 12.7
|
7.2 Percentage of participants
Interval 4.6 to 10.8
|
4.8 Percentage of participants
Interval 2.2 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 deg C to 38.4 deg C
|
4.3 Percentage of participants
Interval 2.0 to 8.1
|
1.6 Percentage of participants
Interval 0.3 to 4.5
|
2.5 Percentage of participants
Interval 0.8 to 5.7
|
4.8 Percentage of participants
Interval 2.6 to 7.9
|
3.9 Percentage of participants
Interval 2.1 to 6.8
|
1.1 Percentage of participants
Interval 0.1 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.4 deg C to 38.9 deg C
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
3.4 Percentage of participants
Interval 1.6 to 6.2
|
3.0 Percentage of participants
Interval 1.4 to 5.5
|
2.7 Percentage of participants
Interval 0.9 to 6.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.9 deg C to 40.0 deg C
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
1.1 Percentage of participants
Interval 0.1 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Moderate
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
1.0 Percentage of participants
Interval 0.2 to 3.0
|
2.0 Percentage of participants
Interval 0.7 to 4.2
|
3.8 Percentage of participants
Interval 1.5 to 7.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Mild
|
7.2 Percentage of participants
Interval 4.1 to 11.7
|
6.8 Percentage of participants
Interval 3.7 to 11.3
|
7.5 Percentage of participants
Interval 4.2 to 12.0
|
14.6 Percentage of participants
Interval 10.8 to 19.2
|
16.8 Percentage of participants
Interval 12.8 to 21.5
|
6.5 Percentage of participants
Interval 3.4 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
1.0 Percentage of participants
Interval 0.2 to 3.0
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Moderate
|
12.6 Percentage of participants
Interval 8.4 to 17.9
|
12.0 Percentage of participants
Interval 7.7 to 17.4
|
10.9 Percentage of participants
Interval 7.0 to 16.1
|
34.7 Percentage of participants
Interval 29.3 to 40.4
|
28.9 Percentage of participants
Interval 23.9 to 34.4
|
22.0 Percentage of participants
Interval 16.3 to 28.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Severe
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
0 Percentage of participants
Interval 0.0 to 1.9
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
3.4 Percentage of participants
Interval 1.6 to 6.2
|
2.3 Percentage of participants
Interval 0.9 to 4.7
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Any
|
30.9 Percentage of participants
Interval 24.7 to 37.7
|
27.1 Percentage of participants
Interval 20.9 to 34.0
|
27.4 Percentage of participants
Interval 21.3 to 34.1
|
47.6 Percentage of participants
Interval 41.8 to 53.5
|
45.1 Percentage of participants
Interval 39.4 to 50.8
|
27.4 Percentage of participants
Interval 21.1 to 34.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Mild
|
20.3 Percentage of participants
Interval 15.0 to 26.4
|
15.6 Percentage of participants
Interval 10.8 to 21.5
|
16.4 Percentage of participants
Interval 11.6 to 22.3
|
27.2 Percentage of participants
Interval 22.2 to 32.7
|
25.7 Percentage of participants
Interval 20.8 to 31.0
|
10.2 Percentage of participants
Interval 6.3 to 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: Unknown
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Any
|
32.4 Percentage of participants
Interval 26.0 to 39.2
|
26.6 Percentage of participants
Interval 20.5 to 33.4
|
28.4 Percentage of participants
Interval 22.2 to 35.1
|
64.6 Percentage of participants
Interval 58.9 to 70.1
|
60.5 Percentage of participants
Interval 54.8 to 66.1
|
39.2 Percentage of participants
Interval 32.2 to 46.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Moderate
|
10.1 Percentage of participants
Interval 6.4 to 15.1
|
9.4 Percentage of participants
Interval 5.7 to 14.4
|
10.4 Percentage of participants
Interval 6.6 to 15.5
|
18.4 Percentage of participants
Interval 14.1 to 23.3
|
17.4 Percentage of participants
Interval 13.3 to 22.2
|
16.7 Percentage of participants
Interval 11.6 to 22.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Mild
|
18.8 Percentage of participants
Interval 13.8 to 24.8
|
14.6 Percentage of participants
Interval 9.9 to 20.4
|
16.4 Percentage of participants
Interval 11.6 to 22.3
|
26.5 Percentage of participants
Interval 21.6 to 32.0
|
29.3 Percentage of participants
Interval 24.2 to 34.7
|
16.7 Percentage of participants
Interval 11.6 to 22.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
2.1 Percentage of participants
Interval 0.6 to 5.2
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
2.0 Percentage of participants
Interval 0.8 to 4.4
|
2.0 Percentage of participants
Interval 0.7 to 4.2
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Any
|
15.0 Percentage of participants
Interval 10.4 to 20.6
|
11.5 Percentage of participants
Interval 7.3 to 16.8
|
10.4 Percentage of participants
Interval 6.6 to 15.5
|
31.6 Percentage of participants
Interval 26.4 to 37.3
|
26.3 Percentage of participants
Interval 21.5 to 31.6
|
14.0 Percentage of participants
Interval 9.3 to 19.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Mild
|
10.1 Percentage of participants
Interval 6.4 to 15.1
|
6.8 Percentage of participants
Interval 3.7 to 11.3
|
8.0 Percentage of participants
Interval 4.6 to 12.6
|
13.3 Percentage of participants
Interval 9.6 to 17.7
|
15.1 Percentage of participants
Interval 11.3 to 19.7
|
7.0 Percentage of participants
Interval 3.8 to 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Moderate
|
4.3 Percentage of participants
Interval 2.0 to 8.1
|
4.7 Percentage of participants
Interval 2.2 to 8.7
|
2.5 Percentage of participants
Interval 0.8 to 5.7
|
17.0 Percentage of participants
Interval 12.9 to 21.8
|
10.2 Percentage of participants
Interval 7.0 to 14.2
|
7.0 Percentage of participants
Interval 3.8 to 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
1.4 Percentage of participants
Interval 0.4 to 3.4
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Any
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
2.1 Percentage of participants
Interval 0.6 to 5.2
|
3.5 Percentage of participants
Interval 1.4 to 7.0
|
2.7 Percentage of participants
Interval 1.2 to 5.3
|
1.6 Percentage of participants
Interval 0.5 to 3.8
|
2.2 Percentage of participants
Interval 0.6 to 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Mild
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
1.6 Percentage of participants
Interval 0.3 to 4.5
|
2.5 Percentage of participants
Interval 0.8 to 5.7
|
2.4 Percentage of participants
Interval 1.0 to 4.8
|
1.6 Percentage of participants
Interval 0.5 to 3.8
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 2.9
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.2
|
1.6 Percentage of participants
Interval 0.3 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Any
|
9.2 Percentage of participants
Interval 5.6 to 14.0
|
8.3 Percentage of participants
Interval 4.8 to 13.2
|
6.5 Percentage of participants
Interval 3.5 to 10.8
|
8.5 Percentage of participants
Interval 5.6 to 12.3
|
11.5 Percentage of participants
Interval 8.2 to 15.6
|
8.1 Percentage of participants
Interval 4.6 to 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Mild
|
8.2 Percentage of participants
Interval 4.9 to 12.8
|
7.8 Percentage of participants
Interval 4.4 to 12.6
|
5.0 Percentage of participants
Interval 2.4 to 9.0
|
7.5 Percentage of participants
Interval 4.7 to 11.1
|
9.2 Percentage of participants
Interval 6.2 to 13.0
|
3.8 Percentage of participants
Interval 1.5 to 7.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Any
|
15.5 Percentage of participants
Interval 10.8 to 21.1
|
16.1 Percentage of participants
Interval 11.2 to 22.1
|
13.9 Percentage of participants
Interval 9.5 to 19.5
|
34.0 Percentage of participants
Interval 28.6 to 39.7
|
28.3 Percentage of participants
Interval 23.3 to 33.7
|
19.9 Percentage of participants
Interval 14.4 to 26.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Moderate
|
8.2 Percentage of participants
Interval 4.9 to 12.8
|
9.4 Percentage of participants
Interval 5.7 to 14.4
|
6.5 Percentage of participants
Interval 3.5 to 10.8
|
18.7 Percentage of participants
Interval 14.4 to 23.6
|
10.5 Percentage of participants
Interval 7.3 to 14.5
|
12.9 Percentage of participants
Interval 8.4 to 18.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
0.5 Percentage of participants
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Any
|
11.1 Percentage of participants
Interval 7.2 to 16.2
|
13.5 Percentage of participants
Interval 9.0 to 19.2
|
10.0 Percentage of participants
Interval 6.2 to 14.9
|
23.5 Percentage of participants
Interval 18.7 to 28.7
|
15.1 Percentage of participants
Interval 11.3 to 19.7
|
12.4 Percentage of participants
Interval 8.0 to 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Mild
|
5.3 Percentage of participants
Interval 2.7 to 9.3
|
6.8 Percentage of participants
Interval 3.7 to 11.3
|
4.5 Percentage of participants
Interval 2.1 to 8.3
|
10.2 Percentage of participants
Interval 7.0 to 14.2
|
7.9 Percentage of participants
Interval 5.1 to 11.5
|
3.8 Percentage of participants
Interval 1.5 to 7.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Moderate
|
5.3 Percentage of participants
Interval 2.7 to 9.3
|
6.3 Percentage of participants
Interval 3.3 to 10.7
|
5.5 Percentage of participants
Interval 2.8 to 9.6
|
12.2 Percentage of participants
Interval 8.7 to 16.5
|
7.2 Percentage of participants
Interval 4.6 to 10.8
|
8.6 Percentage of participants
Interval 5.0 to 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 2Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 2 and 'n' signifies participants evaluable for specified rows and received two doses of study vaccination for SSD. Participants of SSD: Cohort 1: Group 1 did not receive Vaccination 2 and therefore were not analyzed for this outcome measure.
Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C, categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=157 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=197 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=219 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=142 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: Any
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
5.1 Percentage of participants
Interval 2.5 to 9.2
|
6.0 Percentage of participants
Interval 3.2 to 10.0
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever:>=38.0 deg C-38.4 deg C
|
0 Percentage of participants
Interval 0.0 to 2.3
|
2.6 Percentage of participants
Interval 0.8 to 5.9
|
3.7 Percentage of participants
Interval 1.6 to 7.1
|
0.7 Percentage of participants
Interval 0.0 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever:>40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: Unknown
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Any
|
17.8 Percentage of participants
Interval 12.2 to 24.7
|
60.9 Percentage of participants
Interval 53.7 to 67.8
|
54.3 Percentage of participants
Interval 47.5 to 61.1
|
27.0 Percentage of participants
Interval 19.8 to 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Mild
|
11.5 Percentage of participants
Interval 6.9 to 17.5
|
27.9 Percentage of participants
Interval 21.8 to 34.7
|
26.9 Percentage of participants
Interval 21.2 to 33.3
|
13.5 Percentage of participants
Interval 8.3 to 20.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Mild
|
13.4 Percentage of participants
Interval 8.5 to 19.7
|
26.5 Percentage of participants
Interval 20.5 to 33.3
|
18.0 Percentage of participants
Interval 13.1 to 23.7
|
10.6 Percentage of participants
Interval 6.0 to 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Moderate
|
10.8 Percentage of participants
Interval 6.4 to 16.8
|
13.3 Percentage of participants
Interval 8.9 to 18.8
|
17.1 Percentage of participants
Interval 12.3 to 22.7
|
9.2 Percentage of participants
Interval 5.0 to 15.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 1.9
|
2.3 Percentage of participants
Interval 0.8 to 5.3
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Mild
|
7.0 Percentage of participants
Interval 3.5 to 12.2
|
10.7 Percentage of participants
Interval 6.7 to 15.8
|
12.4 Percentage of participants
Interval 8.4 to 17.6
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever:>38.4 deg C-38.9 deg C
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
1.8 Percentage of participants
Interval 0.5 to 4.7
|
1.4 Percentage of participants
Interval 0.2 to 5.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever:>38.9 deg C-40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 2.3
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
0.5 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Moderate
|
5.7 Percentage of participants
Interval 2.7 to 10.6
|
32.0 Percentage of participants
Interval 25.5 to 39.0
|
25.1 Percentage of participants
Interval 19.5 to 31.4
|
12.1 Percentage of participants
Interval 7.2 to 18.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
2.3 Percentage of participants
Interval 0.7 to 5.2
|
1.4 Percentage of participants
Interval 0.2 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Any
|
24.8 Percentage of participants
Interval 18.3 to 32.4
|
39.8 Percentage of participants
Interval 32.9 to 47.0
|
37.3 Percentage of participants
Interval 30.9 to 44.1
|
19.7 Percentage of participants
Interval 13.5 to 27.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Any
|
12.1 Percentage of participants
Interval 7.4 to 18.3
|
21.8 Percentage of participants
Interval 16.3 to 28.3
|
19.4 Percentage of participants
Interval 14.3 to 25.2
|
7.1 Percentage of participants
Interval 3.5 to 12.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Moderate
|
5.1 Percentage of participants
Interval 2.2 to 9.8
|
10.7 Percentage of participants
Interval 6.7 to 15.8
|
6.5 Percentage of participants
Interval 3.6 to 10.6
|
5.0 Percentage of participants
Interval 2.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Any
|
2.5 Percentage of participants
Interval 0.7 to 6.4
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
1.8 Percentage of participants
Interval 0.5 to 4.7
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Mild
|
1.9 Percentage of participants
Interval 0.4 to 5.5
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
1.8 Percentage of participants
Interval 0.5 to 4.7
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Moderate
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Any
|
5.1 Percentage of participants
Interval 2.2 to 9.8
|
9.7 Percentage of participants
Interval 5.9 to 14.7
|
6.0 Percentage of participants
Interval 3.2 to 10.0
|
6.4 Percentage of participants
Interval 3.0 to 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Mild
|
3.8 Percentage of participants
Interval 1.4 to 8.1
|
8.2 Percentage of participants
Interval 4.7 to 12.9
|
5.1 Percentage of participants
Interval 2.6 to 8.9
|
4.3 Percentage of participants
Interval 1.6 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Moderate
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
1.5 Percentage of participants
Interval 0.3 to 4.4
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Any
|
10.8 Percentage of participants
Interval 6.4 to 16.8
|
27.6 Percentage of participants
Interval 21.4 to 34.4
|
26.7 Percentage of participants
Interval 21.0 to 33.1
|
8.6 Percentage of participants
Interval 4.5 to 14.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Mild
|
5.7 Percentage of participants
Interval 2.7 to 10.6
|
17.9 Percentage of participants
Interval 12.8 to 23.9
|
14.7 Percentage of participants
Interval 10.3 to 20.2
|
4.3 Percentage of participants
Interval 1.6 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Moderate
|
4.5 Percentage of participants
Interval 1.8 to 9.0
|
9.7 Percentage of participants
Interval 5.9 to 14.7
|
11.1 Percentage of participants
Interval 7.2 to 16.0
|
4.3 Percentage of participants
Interval 1.6 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Any
|
7.6 Percentage of participants
Interval 4.0 to 13.0
|
14.3 Percentage of participants
Interval 9.7 to 20.0
|
12.0 Percentage of participants
Interval 8.0 to 17.1
|
5.7 Percentage of participants
Interval 2.5 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Mild
|
3.2 Percentage of participants
Interval 1.0 to 7.3
|
7.1 Percentage of participants
Interval 4.0 to 11.7
|
6.5 Percentage of participants
Interval 3.6 to 10.6
|
2.1 Percentage of participants
Interval 0.4 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Moderate
|
4.5 Percentage of participants
Interval 1.8 to 9.0
|
6.1 Percentage of participants
Interval 3.2 to 10.5
|
5.5 Percentage of participants
Interval 2.9 to 9.5
|
3.6 Percentage of participants
Interval 1.2 to 8.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after Vaccination 3Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N'= participants who received vaccination 3. Participants of SSD: Cohort 1: Group 1, Group 2 and SSD Cohort 2: Group 3, Group 4 did not receive Vaccination 3 and therefore were not analyzed for this outcome measure.
Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=154 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: Any
|
2.6 Percentage of participants
Interval 0.7 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >=38.0 deg C to 38.4 deg C
|
0.6 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >38.4 deg C to 38.9 deg C
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >38.9 deg C to 40.0 deg C
|
0.6 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fatigue: Any
|
22.7 Percentage of participants
Interval 16.4 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fatigue: Mild
|
3.9 Percentage of participants
Interval 1.4 to 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fatigue: Moderate
|
18.2 Percentage of participants
Interval 12.4 to 25.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fatigue: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Headache: Any
|
25.3 Percentage of participants
Interval 18.7 to 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Headache: Mild
|
9.1 Percentage of participants
Interval 5.1 to 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Headache: Moderate
|
14.9 Percentage of participants
Interval 9.7 to 21.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Headache: Severe
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Chills: Any
|
9.1 Percentage of participants
Interval 5.1 to 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Chills: Mild
|
4.5 Percentage of participants
Interval 1.8 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Chills: Moderate
|
3.2 Percentage of participants
Interval 1.1 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Chills: Severe
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Vomiting: Any
|
2.6 Percentage of participants
Interval 0.7 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Vomiting: Mild
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Vomiting: Moderate
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Diarrhea: Any
|
1.9 Percentage of participants
Interval 0.4 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Diarrhea: Mild
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Diarrhea: Moderate
|
0.6 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened muscle pain: Any
|
14.9 Percentage of participants
Interval 9.7 to 21.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened muscle pain: Mild
|
4.5 Percentage of participants
Interval 1.8 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened muscle pain: Moderate
|
10.4 Percentage of participants
Interval 6.1 to 16.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened joint pain: Any
|
9.1 Percentage of participants
Interval 5.1 to 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened joint pain: Mild
|
3.2 Percentage of participants
Interval 1.1 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened joint pain: Moderate
|
5.2 Percentage of participants
Interval 2.3 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened joint pain: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to 1 month after last study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after last study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=216 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=197 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=204 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1
|
3.2 Percentage of participants
Interval 1.3 to 6.6
|
6.1 Percentage of participants
Interval 3.2 to 10.4
|
2.0 Percentage of participants
Interval 0.5 to 4.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: From first study vaccination (Day 1) up to 1 month after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=315 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=323 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2
|
4.1 Percentage of participants
Interval 2.2 to 7.0
|
3.7 Percentage of participants
Interval 1.9 to 6.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: From Vaccination 2 up to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSD.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from Vaccination 2 up to 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=213 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=238 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2
|
2.3 Percentage of participants
Interval 0.8 to 5.4
|
3.8 Percentage of participants
Interval 1.7 to 7.1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: From first study vaccination (Day 1) up to 1 month after Vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSD.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=210 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3
|
6.7 Percentage of participants
Interval 3.7 to 10.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: From Vaccination 3 up to 1 month after Vaccination 3Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received three doses of study vaccination for SSD.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from Vaccination 3 up to 1 month after Vaccination 3 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=172 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3
|
0.6 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
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—
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—
|
PRIMARY outcome
Timeframe: From first study vaccination (Day 1) up to 6 months after last study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention.
A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=216 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=197 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=204 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=210 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
1.5 Percentage of participants
Interval 0.3 to 4.4
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
3.8 Percentage of participants
Interval 1.7 to 7.4
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From vaccination 1 (Day 1) up to 6 months after vaccination 1 (participants received 1 dose only); From vaccination 1 up to before vaccination 2 (participants received 2 doses)Population: Safety population included all participants who received at least 1 dose of the study intervention.
A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=315 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=323 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2
|
1.6 Percentage of participants
Interval 0.5 to 3.7
|
0.6 Percentage of participants
Interval 0.1 to 2.2
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study vaccination (Day 1) up to 6 months after vaccination 2Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSD.
A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=213 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=238 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
1.3 Percentage of participants
Interval 0.3 to 3.6
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 1Population: Evaluable immunogenicity population (EIP) included all eligible randomized participants who received 1st study intervention to which they were randomized (Group 3, 4), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 3, 4), have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
GMR was calculated based on GMT levels of SSD: Cohort 2: Group 3 and SSD: Cohort 2: Group 4 and reported in statistical analysis section below. GMT of SARS-CoV-2 Omicron strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after first study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=132 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=141 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4
|
1929.2 Titer
Interval 1631.5 to 2281.1
|
1099.6 Titer
Interval 932.0 to 1297.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 1Population: Evaluable immunogenicity population (EIP) included all eligible randomized participants who received 1st study intervention to which they were randomized (Group 3, 4), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 3, 4), had no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after first study vaccination was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=130 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=140 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4
|
62.3 Percentage of participants
Interval 53.4 to 70.7
|
39.3 Percentage of participants
Interval 31.1 to 47.9
|
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—
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—
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PRIMARY outcome
Timeframe: 1 month after Vaccination 1Population: Evaluable immunogenicity population (EIP) included all eligible randomized participants who received 1st study intervention to which they were randomized (Groups 1, 2b), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Groups 1, 2b), have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after first study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=100 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=100 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b
|
5094.1 Titer
Interval 4118.2 to 6301.2
|
1775.6 Titer
Interval 1484.8 to 2123.4
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: For Cohort 1 Group 2b:1 month after Vaccination 1; for Cohort 1 Group 2: 1 month after Vaccination 2Population: EIP: all eligible participants received 1st study drug as randomized (Group 2b) or received 2 doses of study drug as randomized with Dose 2 received within 19-42 days after Dose1 (Group 2), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 2b) or 28-42 days after 2nd study vaccination (Group 2), had no other important protocol deviations as determined by clinician. Here 'N'=participants evaluable for this outcome measure.
GMR was calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after Vaccination 2 for Group 2 and 1 month after Vaccination 1 for Group 2b was reported. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=100 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=100 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b
|
4684.3 Titer
Interval 3937.4 to 5573.0
|
1775.6 Titer
Interval 1484.8 to 2123.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 1Population: Evaluable immunogenicity population included all eligible randomized participants who received 1st study intervention to which they were randomized (Group 1, 2b), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 1, 2b), had no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.
Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after first study vaccination was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=100 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=100 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b
|
88.0 Percentage of participants
Interval 80.0 to 93.6
|
59.0 Percentage of participants
Interval 48.7 to 68.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: For Cohort 1 Group 2b:1 month after Vaccination 1; for Cohort 1 Group 2: 1 month after Vaccination 2Population: EIP: all eligible participants received 1st study drug as randomized (Group 2b) or received 2 doses of study drug as randomized with Dose 2 received within 19-42 days after Dose1 (Group 2), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 2b) or 28-42 days after 2nd study vaccination (Group 2), had no other important protocol deviations as determined by clinician. Here 'N'=participants evaluable for this outcome measure.
Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below LLOQ, postvaccination measure of \>= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after second study vaccination for Group 2 and 1 month after study vaccination for Group 2b was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=100 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=100 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b
|
80.0 Percentage of participants
Interval 70.8 to 87.3
|
59.0 Percentage of participants
Interval 48.7 to 68.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: 1 month after Vaccination 2Population: EIP:eligible participants received 2 doses of study drug as randomized with Dose2 received within 19-42 days after Dose1 (SSD Cohort 3:Group 5), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 2nd study vaccination, had no other important protocol deviations as determined by clinician. Data of eligible participants from Study C4591001 Phase 3 BNT162b2 single arm 18-55 years was included for comparison.'N'=participants evaluable for outcome measure.
GMR calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMR comparison between GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers of participants of SSD Cohort 3: Group 5 to GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers of participants of study C4591001 (NCT04368728) Phase 3 BNT162b2 single arm 18-55 years of age, at 1 month after vaccination 2 was reported. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=152 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=157 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3
|
2892.2 Titer
Interval 2522.3 to 3316.3
|
290.6 Titer
Interval 241.2 to 350.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 2Population: EIP:eligible participants received 2 doses of study drug as randomized with Dose2 received within 19-42 days after Dose1 (SSD Cohort 3:Group 5), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 2nd study vaccination, had no other important protocol deviations as determined by clinician. Data of eligible participants from Study C4591001 Phase 3 BNT162b2 single arm 18-55 years was included for comparison.'N'=participants evaluable for outcome measure.
EIP:eligible participants received 2 doses of study drug as randomized with Dose2 received within 19-42 days after Dose1 (SSD Cohort 3:Group 5), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 2nd study vaccination, had no other important protocol deviations as determined by clinician. Data of eligible participants from Study C4591001 Phase 3 BNT162b2 single arm 18-55 years was included for comparison.'N'=participants evaluable for outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=152 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=156 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3
|
86.2 Percentage of participants
Interval 79.7 to 91.2
|
80.8 Percentage of participants
Interval 73.7 to 86.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after study vaccinationPopulation: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm),severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis/exfoliative dermatitis \[redness\]).Pain at injection site was graded as mild (did not interfere with activity),moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit/hospitalization for severe pain). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions within 7 days after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=30 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=480 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=158 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=320 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=298 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=298 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=301 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=301 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=301 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=312 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Any
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
8.1 Percentage of participants
Interval 5.8 to 10.9
|
6.3 Percentage of participants
Interval 3.1 to 11.3
|
10.9 Percentage of participants
Interval 7.7 to 14.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
6.4 Percentage of participants
Interval 3.9 to 9.8
|
10.4 Percentage of participants
Interval 7.2 to 14.4
|
6.3 Percentage of participants
Interval 3.8 to 9.7
|
10.6 Percentage of participants
Interval 7.4 to 14.7
|
7.0 Percentage of participants
Interval 4.4 to 10.5
|
7.4 Percentage of participants
Interval 4.7 to 10.9
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Mild
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
3.8 Percentage of participants
Interval 2.2 to 5.9
|
4.4 Percentage of participants
Interval 1.8 to 8.9
|
6.3 Percentage of participants
Interval 3.9 to 9.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
4.0 Percentage of participants
Interval 2.1 to 6.9
|
6.0 Percentage of participants
Interval 3.6 to 9.4
|
3.3 Percentage of participants
Interval 1.6 to 6.0
|
4.0 Percentage of participants
Interval 2.1 to 6.9
|
4.3 Percentage of participants
Interval 2.3 to 7.3
|
3.5 Percentage of participants
Interval 1.8 to 6.2
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Mild
|
60.0 Percentage of participants
Interval 40.6 to 77.3
|
76.7 Percentage of participants
Interval 57.7 to 90.1
|
33.3 Percentage of participants
Interval 17.3 to 52.8
|
55.2 Percentage of participants
Interval 50.6 to 59.7
|
67.7 Percentage of participants
Interval 59.8 to 74.9
|
45.3 Percentage of participants
Interval 39.8 to 50.9
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
60.0 Percentage of participants
Interval 36.1 to 80.9
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
51.7 Percentage of participants
Interval 45.8 to 57.5
|
53.4 Percentage of participants
Interval 47.5 to 59.1
|
52.8 Percentage of participants
Interval 47.0 to 58.6
|
44.9 Percentage of participants
Interval 39.1 to 50.7
|
52.8 Percentage of participants
Interval 47.0 to 58.6
|
55.4 Percentage of participants
Interval 49.7 to 61.0
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Moderate
|
30.0 Percentage of participants
Interval 14.7 to 49.4
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
60.0 Percentage of participants
Interval 40.6 to 77.3
|
26.0 Percentage of participants
Interval 22.2 to 30.2
|
13.3 Percentage of participants
Interval 8.4 to 19.6
|
39.4 Percentage of participants
Interval 34.0 to 45.0
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
8.1 Percentage of participants
Interval 5.2 to 11.7
|
17.4 Percentage of participants
Interval 13.3 to 22.2
|
13.3 Percentage of participants
Interval 9.7 to 17.7
|
25.2 Percentage of participants
Interval 20.4 to 30.6
|
5.0 Percentage of participants
Interval 2.8 to 8.1
|
12.2 Percentage of participants
Interval 8.8 to 16.3
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
1.7 Percentage of participants
Interval 0.7 to 3.3
|
0 Percentage of participants
Interval 0.0 to 2.3
|
1.6 Percentage of participants
Interval 0.5 to 3.6
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
4.2 Percentage of participants
Interval 2.6 to 6.4
|
1.9 Percentage of participants
Interval 0.4 to 5.4
|
4.4 Percentage of participants
Interval 2.4 to 7.2
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
2.0 Percentage of participants
Interval 0.7 to 4.3
|
4.0 Percentage of participants
Interval 2.1 to 6.9
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
6.6 Percentage of participants
Interval 4.1 to 10.1
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
3.2 Percentage of participants
Interval 1.5 to 5.8
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0.2 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0.3 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Any
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
9.6 Percentage of participants
Interval 7.1 to 12.6
|
7.0 Percentage of participants
Interval 3.5 to 12.1
|
11.9 Percentage of participants
Interval 8.5 to 15.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
6.0 Percentage of participants
Interval 3.6 to 9.4
|
13.1 Percentage of participants
Interval 9.5 to 17.5
|
8.3 Percentage of participants
Interval 5.4 to 12.0
|
10.0 Percentage of participants
Interval 6.8 to 13.9
|
6.6 Percentage of participants
Interval 4.1 to 10.1
|
5.4 Percentage of participants
Interval 3.2 to 8.6
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Mild
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
5.0 Percentage of participants
Interval 3.2 to 7.3
|
4.4 Percentage of participants
Interval 1.8 to 8.9
|
6.3 Percentage of participants
Interval 3.9 to 9.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
3.4 Percentage of participants
Interval 1.6 to 6.1
|
7.7 Percentage of participants
Interval 5.0 to 11.4
|
5.0 Percentage of participants
Interval 2.8 to 8.1
|
4.0 Percentage of participants
Interval 2.1 to 6.9
|
4.7 Percentage of participants
Interval 2.6 to 7.7
|
2.9 Percentage of participants
Interval 1.3 to 5.4
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
4.4 Percentage of participants
Interval 2.7 to 6.6
|
2.5 Percentage of participants
Interval 0.7 to 6.4
|
5.3 Percentage of participants
Interval 3.1 to 8.4
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
5.4 Percentage of participants
Interval 3.1 to 8.6
|
3.3 Percentage of participants
Interval 1.6 to 6.0
|
5.3 Percentage of participants
Interval 3.1 to 8.5
|
2.0 Percentage of participants
Interval 0.7 to 4.3
|
2.2 Percentage of participants
Interval 0.9 to 4.6
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0.2 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0.3 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Any
|
90.0 Percentage of participants
Interval 73.5 to 97.9
|
83.3 Percentage of participants
Interval 65.3 to 94.4
|
96.7 Percentage of participants
Interval 82.8 to 99.9
|
82.9 Percentage of participants
Interval 79.2 to 86.2
|
81.0 Percentage of participants
Interval 74.0 to 86.8
|
86.3 Percentage of participants
Interval 82.0 to 89.8
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
100.0 Percentage of participants
Interval 83.2 to 100.0
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
60.1 Percentage of participants
Interval 54.3 to 65.7
|
71.1 Percentage of participants
Interval 65.6 to 76.2
|
66.1 Percentage of participants
Interval 60.5 to 71.4
|
70.8 Percentage of participants
Interval 65.3 to 75.8
|
58.1 Percentage of participants
Interval 52.3 to 63.8
|
67.9 Percentage of participants
Interval 62.5 to 73.1
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after study vaccinationPopulation: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants evaluable for this outcome measure.
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C \& \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \> 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=30 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=480 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=158 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=320 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=298 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=298 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=301 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=301 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=301 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=312 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Moderate
|
43.3 Percentage of participants
Interval 25.5 to 62.6
|
33.3 Percentage of participants
Interval 17.3 to 52.8
|
40.0 Percentage of participants
Interval 22.7 to 59.4
|
44.0 Percentage of participants
Interval 39.5 to 48.5
|
34.8 Percentage of participants
Interval 27.4 to 42.8
|
46.9 Percentage of participants
Interval 41.3 to 52.5
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
21.5 Percentage of participants
Interval 17.0 to 26.6
|
26.8 Percentage of participants
Interval 21.9 to 32.3
|
29.6 Percentage of participants
Interval 24.5 to 35.1
|
30.6 Percentage of participants
Interval 25.4 to 36.1
|
18.3 Percentage of participants
Interval 14.1 to 23.1
|
28.2 Percentage of participants
Interval 23.3 to 33.5
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
0.6 Percentage of participants
Interval 0.1 to 1.8
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
1.9 Percentage of participants
Interval 0.7 to 4.0
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
2.3 Percentage of participants
Interval 0.9 to 4.7
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Mild
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
18.3 Percentage of participants
Interval 15.0 to 22.1
|
20.3 Percentage of participants
Interval 14.3 to 27.4
|
17.8 Percentage of participants
Interval 13.8 to 22.5
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
11.7 Percentage of participants
Interval 8.3 to 16.0
|
10.1 Percentage of participants
Interval 6.9 to 14.1
|
11.6 Percentage of participants
Interval 8.2 to 15.8
|
12.6 Percentage of participants
Interval 9.1 to 16.9
|
13.3 Percentage of participants
Interval 9.7 to 17.7
|
14.1 Percentage of participants
Interval 10.4 to 18.5
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >= 38.0 deg C
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
0 Percentage of participants
Interval 0.0 to 11.6
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
10.0 Percentage of participants
Interval 7.5 to 13.0
|
10.8 Percentage of participants
Interval 6.4 to 16.7
|
19.4 Percentage of participants
Interval 15.2 to 24.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
3.7 Percentage of participants
Interval 1.9 to 6.5
|
7.4 Percentage of participants
Interval 4.7 to 11.0
|
8.3 Percentage of participants
Interval 5.4 to 12.0
|
9.0 Percentage of participants
Interval 6.0 to 12.8
|
5.0 Percentage of participants
Interval 2.8 to 8.1
|
7.7 Percentage of participants
Interval 5.0 to 11.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >= 38.0 deg C to 38.4 deg C
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
4.2 Percentage of participants
Interval 2.6 to 6.4
|
6.3 Percentage of participants
Interval 3.1 to 11.3
|
6.9 Percentage of participants
Interval 4.4 to 10.2
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
2.0 Percentage of participants
Interval 0.7 to 4.3
|
3.7 Percentage of participants
Interval 1.9 to 6.5
|
3.7 Percentage of participants
Interval 1.8 to 6.4
|
4.7 Percentage of participants
Interval 2.6 to 7.7
|
3.7 Percentage of participants
Interval 1.8 to 6.4
|
5.4 Percentage of participants
Interval 3.2 to 8.6
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >38.4 deg C to 38.9 deg C
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.8 Percentage of participants
Interval 2.2 to 5.9
|
3.8 Percentage of participants
Interval 1.4 to 8.1
|
8.1 Percentage of participants
Interval 5.4 to 11.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
1.7 Percentage of participants
Interval 0.5 to 3.9
|
3.7 Percentage of participants
Interval 1.9 to 6.5
|
3.7 Percentage of participants
Interval 1.8 to 6.4
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
1.6 Percentage of participants
Interval 0.5 to 3.7
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
2.1 Percentage of participants
Interval 1.0 to 3.8
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
4.4 Percentage of participants
Interval 2.4 to 7.2
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >40 deg C
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Any
|
66.7 Percentage of participants
Interval 47.2 to 82.7
|
63.3 Percentage of participants
Interval 43.9 to 80.1
|
70.0 Percentage of participants
Interval 50.6 to 85.3
|
73.8 Percentage of participants
Interval 69.6 to 77.6
|
68.4 Percentage of participants
Interval 60.5 to 75.5
|
77.5 Percentage of participants
Interval 72.5 to 82.0
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
45.3 Percentage of participants
Interval 39.6 to 51.1
|
52.3 Percentage of participants
Interval 46.5 to 58.1
|
52.5 Percentage of participants
Interval 46.7 to 58.3
|
58.8 Percentage of participants
Interval 53.0 to 64.4
|
49.2 Percentage of participants
Interval 43.4 to 55.0
|
57.4 Percentage of participants
Interval 51.7 to 62.9
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Mild
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
26.7 Percentage of participants
Interval 12.3 to 45.9
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
25.2 Percentage of participants
Interval 21.4 to 29.3
|
32.3 Percentage of participants
Interval 25.1 to 40.2
|
25.9 Percentage of participants
Interval 21.2 to 31.1
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
23.5 Percentage of participants
Interval 18.8 to 28.7
|
22.5 Percentage of participants
Interval 17.9 to 27.7
|
20.3 Percentage of participants
Interval 15.9 to 25.3
|
24.6 Percentage of participants
Interval 19.8 to 29.9
|
29.2 Percentage of participants
Interval 24.2 to 34.7
|
27.2 Percentage of participants
Interval 22.4 to 32.5
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Severe
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
4.6 Percentage of participants
Interval 2.9 to 6.9
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
4.7 Percentage of participants
Interval 2.6 to 7.6
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
3.0 Percentage of participants
Interval 1.4 to 5.7
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
3.7 Percentage of participants
Interval 1.8 to 6.4
|
1.7 Percentage of participants
Interval 0.5 to 3.8
|
1.9 Percentage of participants
Interval 0.7 to 4.1
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Any
|
46.7 Percentage of participants
Interval 28.3 to 65.7
|
30.0 Percentage of participants
Interval 14.7 to 49.4
|
60.0 Percentage of participants
Interval 40.6 to 77.3
|
53.5 Percentage of participants
Interval 49.0 to 58.1
|
50.0 Percentage of participants
Interval 42.0 to 58.0
|
57.5 Percentage of participants
Interval 51.9 to 63.0
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
50.0 Percentage of participants
Interval 27.2 to 72.8
|
26.5 Percentage of participants
Interval 21.6 to 31.9
|
38.9 Percentage of participants
Interval 33.4 to 44.7
|
36.5 Percentage of participants
Interval 31.1 to 42.3
|
36.5 Percentage of participants
Interval 31.1 to 42.3
|
33.6 Percentage of participants
Interval 28.2 to 39.2
|
36.5 Percentage of participants
Interval 31.2 to 42.1
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Mild
|
40.0 Percentage of participants
Interval 22.7 to 59.4
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
26.7 Percentage of participants
Interval 12.3 to 45.9
|
27.7 Percentage of participants
Interval 23.7 to 31.9
|
29.1 Percentage of participants
Interval 22.2 to 36.9
|
27.5 Percentage of participants
Interval 22.7 to 32.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
15.8 Percentage of participants
Interval 11.8 to 20.4
|
23.5 Percentage of participants
Interval 18.8 to 28.7
|
22.3 Percentage of participants
Interval 17.7 to 27.4
|
20.6 Percentage of participants
Interval 16.2 to 25.6
|
23.6 Percentage of participants
Interval 18.9 to 28.8
|
24.4 Percentage of participants
Interval 19.7 to 29.5
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Moderate
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
30.0 Percentage of participants
Interval 14.7 to 49.4
|
24.2 Percentage of participants
Interval 20.4 to 28.3
|
19.0 Percentage of participants
Interval 13.2 to 26.0
|
27.2 Percentage of participants
Interval 22.4 to 32.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
10.4 Percentage of participants
Interval 7.2 to 14.4
|
14.4 Percentage of participants
Interval 10.6 to 18.9
|
13.3 Percentage of participants
Interval 9.7 to 17.7
|
14.6 Percentage of participants
Interval 10.8 to 19.1
|
9.6 Percentage of participants
Interval 6.5 to 13.5
|
10.9 Percentage of participants
Interval 7.7 to 14.9
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
1.7 Percentage of participants
Interval 0.7 to 3.3
|
1.9 Percentage of participants
Interval 0.4 to 5.4
|
2.8 Percentage of participants
Interval 1.3 to 5.3
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
1.3 Percentage of participants
Interval 0.4 to 3.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Any
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
40.0 Percentage of participants
Interval 22.7 to 59.4
|
35.6 Percentage of participants
Interval 31.3 to 40.1
|
27.8 Percentage of participants
Interval 21.0 to 35.5
|
38.4 Percentage of participants
Interval 33.1 to 44.0
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
16.4 Percentage of participants
Interval 12.4 to 21.1
|
24.2 Percentage of participants
Interval 19.4 to 29.4
|
25.6 Percentage of participants
Interval 20.7 to 30.9
|
25.6 Percentage of participants
Interval 20.7 to 30.9
|
13.0 Percentage of participants
Interval 9.4 to 17.3
|
23.7 Percentage of participants
Interval 19.1 to 28.8
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Mild
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
20.4 Percentage of participants
Interval 16.9 to 24.3
|
15.8 Percentage of participants
Interval 10.5 to 22.5
|
18.8 Percentage of participants
Interval 14.6 to 23.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.7 Percentage of participants
Interval 7.5 to 14.8
|
13.1 Percentage of participants
Interval 9.5 to 17.5
|
13.0 Percentage of participants
Interval 9.4 to 17.3
|
11.3 Percentage of participants
Interval 8.0 to 15.4
|
8.3 Percentage of participants
Interval 5.4 to 12.0
|
13.5 Percentage of participants
Interval 9.9 to 17.8
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Moderate
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
14.6 Percentage of participants
Interval 11.5 to 18.1
|
11.4 Percentage of participants
Interval 6.9 to 17.4
|
17.8 Percentage of participants
Interval 13.8 to 22.5
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.7 Percentage of participants
Interval 3.4 to 9.0
|
10.4 Percentage of participants
Interval 7.2 to 14.4
|
12.0 Percentage of participants
Interval 8.5 to 16.2
|
12.0 Percentage of participants
Interval 8.5 to 16.2
|
4.7 Percentage of participants
Interval 2.6 to 7.7
|
10.3 Percentage of participants
Interval 7.1 to 14.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.1 Percentage of participants
Interval 1.8 to 5.1
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
3.8 Percentage of participants
Interval 2.0 to 6.5
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
1.7 Percentage of participants
Interval 0.5 to 3.9
|
3.0 Percentage of participants
Interval 1.4 to 5.6
|
2.7 Percentage of participants
Interval 1.2 to 5.2
|
1.7 Percentage of participants
Interval 0.5 to 3.8
|
1.3 Percentage of participants
Interval 0.4 to 3.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
2.7 Percentage of participants
Interval 1.4 to 4.6
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
3.4 Percentage of participants
Interval 1.7 to 6.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
2.3 Percentage of participants
Interval 0.9 to 4.7
|
2.3 Percentage of participants
Interval 0.9 to 4.7
|
1.7 Percentage of participants
Interval 0.5 to 3.8
|
1.3 Percentage of participants
Interval 0.4 to 3.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0.4 Percentage of participants
Interval 0.1 to 1.5
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0.3 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Any
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
12.7 Percentage of participants
Interval 9.9 to 16.0
|
10.8 Percentage of participants
Interval 6.4 to 16.7
|
12.2 Percentage of participants
Interval 8.8 to 16.3
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
4.4 Percentage of participants
Interval 2.3 to 7.3
|
5.7 Percentage of participants
Interval 3.4 to 9.0
|
8.0 Percentage of participants
Interval 5.2 to 11.6
|
10.3 Percentage of participants
Interval 7.1 to 14.3
|
9.0 Percentage of participants
Interval 6.0 to 12.8
|
6.4 Percentage of participants
Interval 4.0 to 9.7
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Mild
|
16.7 Percentage of participants
Interval 5.6 to 34.7
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
9.6 Percentage of participants
Interval 7.1 to 12.6
|
9.5 Percentage of participants
Interval 5.4 to 15.2
|
10.0 Percentage of participants
Interval 6.9 to 13.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
3.4 Percentage of participants
Interval 1.6 to 6.1
|
3.7 Percentage of participants
Interval 1.9 to 6.5
|
6.6 Percentage of participants
Interval 4.1 to 10.1
|
9.0 Percentage of participants
Interval 6.0 to 12.8
|
6.0 Percentage of participants
Interval 3.6 to 9.3
|
5.8 Percentage of participants
Interval 3.5 to 9.0
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Moderate
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.1 Percentage of participants
Interval 1.8 to 5.1
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
2.2 Percentage of participants
Interval 0.9 to 4.5
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
2.0 Percentage of participants
Interval 0.7 to 4.3
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
1.7 Percentage of participants
Interval 0.5 to 3.8
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
1.3 Percentage of participants
Interval 0.4 to 3.4
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Any
|
30.0 Percentage of participants
Interval 14.7 to 49.4
|
30.0 Percentage of participants
Interval 14.7 to 49.4
|
46.7 Percentage of participants
Interval 28.3 to 65.7
|
39.8 Percentage of participants
Interval 35.4 to 44.3
|
36.7 Percentage of participants
Interval 29.2 to 44.7
|
42.2 Percentage of participants
Interval 36.7 to 47.8
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
19.8 Percentage of participants
Interval 15.4 to 24.8
|
25.5 Percentage of participants
Interval 20.7 to 30.8
|
23.9 Percentage of participants
Interval 19.2 to 29.1
|
30.6 Percentage of participants
Interval 25.4 to 36.1
|
22.3 Percentage of participants
Interval 17.7 to 27.4
|
27.2 Percentage of participants
Interval 22.4 to 32.5
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Moderate
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
21.3 Percentage of participants
Interval 17.7 to 25.2
|
15.8 Percentage of participants
Interval 10.5 to 22.5
|
22.2 Percentage of participants
Interval 17.8 to 27.1
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
8.1 Percentage of participants
Interval 5.2 to 11.7
|
14.4 Percentage of participants
Interval 10.6 to 18.9
|
12.0 Percentage of participants
Interval 8.5 to 16.2
|
15.9 Percentage of participants
Interval 12.0 to 20.6
|
9.0 Percentage of participants
Interval 6.0 to 12.8
|
12.8 Percentage of participants
Interval 9.3 to 17.0
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0.2 Percentage of participants
Interval 0.0 to 1.2
|
0.6 Percentage of participants
Interval 0.0 to 3.5
|
2.2 Percentage of participants
Interval 0.9 to 4.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
1.0 Percentage of participants
Interval 0.2 to 2.9
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
2.0 Percentage of participants
Interval 0.7 to 4.3
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Any
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
16.7 Percentage of participants
Interval 5.6 to 34.7
|
23.3 Percentage of participants
Interval 9.9 to 42.3
|
25.4 Percentage of participants
Interval 21.6 to 29.6
|
20.9 Percentage of participants
Interval 14.8 to 28.1
|
24.1 Percentage of participants
Interval 19.5 to 29.1
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
9.1 Percentage of participants
Interval 6.1 to 12.9
|
16.1 Percentage of participants
Interval 12.1 to 20.8
|
16.6 Percentage of participants
Interval 12.6 to 21.3
|
19.6 Percentage of participants
Interval 15.3 to 24.5
|
11.3 Percentage of participants
Interval 8.0 to 15.4
|
18.6 Percentage of participants
Interval 14.4 to 23.4
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Mild
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
12.5 Percentage of participants
Interval 9.7 to 15.8
|
10.1 Percentage of participants
Interval 5.9 to 15.9
|
9.1 Percentage of participants
Interval 6.2 to 12.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.4 Percentage of participants
Interval 3.1 to 8.6
|
9.7 Percentage of participants
Interval 6.6 to 13.7
|
9.3 Percentage of participants
Interval 6.3 to 13.2
|
8.3 Percentage of participants
Interval 5.4 to 12.0
|
7.6 Percentage of participants
Interval 4.9 to 11.2
|
10.3 Percentage of participants
Interval 7.1 to 14.2
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Moderate
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
12.5 Percentage of participants
Interval 9.7 to 15.8
|
10.8 Percentage of participants
Interval 6.4 to 16.7
|
14.1 Percentage of participants
Interval 10.4 to 18.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
3.7 Percentage of participants
Interval 1.9 to 6.5
|
6.0 Percentage of participants
Interval 3.6 to 9.4
|
7.3 Percentage of participants
Interval 4.6 to 10.9
|
11.0 Percentage of participants
Interval 7.7 to 15.1
|
3.7 Percentage of participants
Interval 1.8 to 6.4
|
8.0 Percentage of participants
Interval 5.3 to 11.6
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0.4 Percentage of participants
Interval 0.1 to 1.5
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0.9 Percentage of participants
Interval 0.2 to 2.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0.3 Percentage of participants
Interval 0.0 to 1.8
|
|
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 1.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.2
|
PRIMARY outcome
Timeframe: From study vaccination up to 1 Month after study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'N' signifies participants evaluable for this outcome measure.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=30 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=482 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=159 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=321 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=305 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=302 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=307 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=306 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=305 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=313 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
7.7 Percentage of participants
Interval 5.5 to 10.4
|
6.3 Percentage of participants
Interval 3.1 to 11.3
|
9.3 Percentage of participants
Interval 6.4 to 13.1
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.9 Percentage of participants
Interval 3.5 to 9.2
|
6.6 Percentage of participants
Interval 4.1 to 10.0
|
8.5 Percentage of participants
Interval 5.6 to 12.2
|
3.6 Percentage of participants
Interval 1.8 to 6.3
|
6.2 Percentage of participants
Interval 3.8 to 9.6
|
10.4 Percentage of participants
Interval 7.3 to 14.4
|
PRIMARY outcome
Timeframe: From study vaccination up to 6 Months after study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'N' signifies participants evaluable for this outcome measure.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=30 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=482 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=159 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=321 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=305 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=302 Participants
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=307 Participants
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=307 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=304 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=313 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0.6 Percentage of participants
Interval 0.1 to 1.8
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
0.9 Percentage of participants
Interval 0.2 to 2.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
2.0 Percentage of participants
Interval 0.7 to 4.2
|
0.7 Percentage of participants
Interval 0.1 to 2.4
|
3.9 Percentage of participants
Interval 2.0 to 6.7
|
1.3 Percentage of participants
Interval 0.4 to 3.3
|
1.3 Percentage of participants
Interval 0.4 to 3.3
|
1.9 Percentage of participants
Interval 0.7 to 4.1
|
PRIMARY outcome
Timeframe: Before study vaccination (pre-dose)Population: Safety population included all participants who received at least 1 dose of the study intervention. As pre-specified in the protocol, this outcome measure was planned to be analyzed only in the Sentinel Cohort in participants of 18 to 55 years of age.
Percentage of participants with elevated troponin I levels before study vaccination were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=30 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 days after study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention. As pre-specified in the protocol, this outcome measure was planned to be analyzed only in the Sentinel Cohort in participants of 18 to 55 years of age.
Percentage of participants with elevated troponin I levels before study vaccination were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=30 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=30 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP: all eligible randomized participants who received study intervention to which they were randomized, had valid and determinate immunogenicity result within 28-42 days after study vaccination, had no other important protocol deviations as determined by the clinician. 'N' = participants evaluable for this outcome measure. As pre-specified in the protocol, this outcome measure was not planned to be analyzed in ''SSE: Expanded Cohort (\> 55 Years): BNT162b2 60 mcg''.
GMR calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=163 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=169 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=174 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=178 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=175 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination
|
455.8 Titer
Interval 365.9 to 567.6
|
1014.5 Titer
Interval 825.6 to 1246.7
|
1435.2 Titer
Interval 1208.1 to 1704.8
|
711.0 Titer
Interval 588.3 to 859.2
|
900.1 Titer
Interval 726.3 to 1115.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after study vaccinationPopulation: EIP: all eligible randomized participants who received study intervention to which they were randomized, had valid and determinate immunogenicity result within 28-42 days after study vaccination, had no other important protocol deviations as determined by the clinician. 'N' = participants evaluable for this outcome measure. As pre-specified in the protocol, this outcome measure was not planned to be analyzed in ''SSE: Expanded Cohort (\> 55 Years): BNT162b2 60 mcg''.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), postvaccination measure of \>= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=149 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=163 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=166 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=169 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=162 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination
|
57.0 Percentage of participants
Interval 48.7 to 65.1
|
76.7 Percentage of participants
Interval 69.4 to 82.9
|
86.1 Percentage of participants
Interval 79.9 to 91.0
|
71.6 Percentage of participants
Interval 64.2 to 78.3
|
67.9 Percentage of participants
Interval 60.1 to 75.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before vaccination (pre-dose)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination.
GMT of SARS-CoV-2 Omicron BA.1 strain neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination
|
41.7 Titer
Interval 22.4 to 77.4
|
33.2 Titer
Interval 17.6 to 62.6
|
32.0 Titer
Interval 17.0 to 60.1
|
36.8 Titer
Interval 17.5 to 77.1
|
78.8 Titer
Interval 29.3 to 211.6
|
21.5 Titer
Interval 14.2 to 32.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after the study vaccinationPopulation: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (necrosis \[swelling\] or necrosis/exfoliative dermatitis \[redness\]). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Any
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
15.8 Percentage of participants
Interval 3.4 to 39.6
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Mild
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Moderate
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Any
|
71.4 Percentage of participants
Interval 47.8 to 88.7
|
94.7 Percentage of participants
Interval 74.0 to 99.9
|
90.5 Percentage of participants
Interval 69.6 to 98.8
|
80.0 Percentage of participants
Interval 56.3 to 94.3
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
90.5 Percentage of participants
Interval 69.6 to 98.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Mild
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
52.6 Percentage of participants
Interval 28.9 to 75.6
|
66.7 Percentage of participants
Interval 43.0 to 85.4
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
57.1 Percentage of participants
Interval 34.0 to 78.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Moderate
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
36.8 Percentage of participants
Interval 16.3 to 61.6
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Any
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
21.1 Percentage of participants
Interval 6.1 to 45.6
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Mild
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination
Redness: Moderate
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7 after the study vaccinationPopulation: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants evaluable for this outcome measure.
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C \& \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \> 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Any
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
15.8 Percentage of participants
Interval 3.4 to 39.6
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Mild
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >= 38.0 deg C
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >= 38.0 deg C to 38.4 deg C
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 16.1
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
0 Percentage of participants
Interval 0.0 to 16.1
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Any
|
47.6 Percentage of participants
Interval 25.7 to 70.2
|
36.8 Percentage of participants
Interval 16.3 to 61.6
|
42.9 Percentage of participants
Interval 21.8 to 66.0
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
50.0 Percentage of participants
Interval 27.2 to 72.8
|
57.1 Percentage of participants
Interval 34.0 to 78.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Mild
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
23.8 Percentage of participants
Interval 8.5 to 47.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Moderate
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
21.1 Percentage of participants
Interval 6.1 to 45.6
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Severe
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Any
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
38.1 Percentage of participants
Interval 18.1 to 61.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Mild
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
15.8 Percentage of participants
Interval 3.4 to 39.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Moderate
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.7
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Moderate
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Any
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Any
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Mild
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Severe
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Any
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
42.1 Percentage of participants
Interval 20.3 to 66.5
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Mild
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
10.0 Percentage of participants
Interval 1.2 to 31.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Moderate
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
31.6 Percentage of participants
Interval 12.6 to 56.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Any
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
15.8 Percentage of participants
Interval 3.4 to 39.6
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Mild
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Moderate
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination up to 1 Month after study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination
|
0 Percentage of participants
Interval 0.0 to 16.1
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination up to 6 Months after study vaccinationPopulation: Safety population included all participants who received at least 1 dose of the study intervention.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination
|
0 Percentage of participants
Interval 0.0 to 16.1
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 16.8
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before vaccination (pre-dose)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination.
GMT of SARS-CoV-2 reference-strain-neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination
|
541.1 Titer
Interval 345.1 to 848.3
|
382.4 Titer
Interval 176.3 to 829.3
|
437.5 Titer
Interval 244.0 to 784.2
|
315.2 Titer
Interval 188.0 to 528.4
|
803.4 Titer
Interval 347.8 to 1855.8
|
256.0 Titer
Interval 135.1 to 485.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before vaccination (pre-dose)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination
|
27.1 Titer
Interval 16.8 to 43.7
|
18.0 Titer
Interval 12.1 to 26.7
|
20.2 Titer
Interval 12.6 to 32.3
|
23.4 Titer
Interval 13.9 to 39.4
|
42.2 Titer
Interval 19.6 to 91.1
|
15.0 Titer
Interval 11.8 to 19.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7
|
146.1 Titer
Interval 102.5 to 208.2
|
101.6 Titer
Interval 48.6 to 212.6
|
217.1 Titer
Interval 97.8 to 481.9
|
315.2 Titer
Interval 164.6 to 603.5
|
337.8 Titer
Interval 133.8 to 852.7
|
222.9 Titer
Interval 125.7 to 395.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7
|
1917.2 Titer
Interval 1153.8 to 3185.7
|
1241.4 Titer
Interval 624.3 to 2468.6
|
1472.3 Titer
Interval 855.4 to 2534.0
|
1499.2 Titer
Interval 838.6 to 2680.4
|
2702.4 Titer
Interval 1419.7 to 5143.8
|
1845.8 Titer
Interval 1087.4 to 3133.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=17 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7
|
75.5 Titer
Interval 52.7 to 108.0
|
56.6 Titer
Interval 32.1 to 99.8
|
73.0 Titer
Interval 38.7 to 137.9
|
76.1 Titer
Interval 46.0 to 125.9
|
123.6 Titer
Interval 63.8 to 239.5
|
70.7 Titer
Interval 48.5 to 103.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 (1 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1
|
420.0 Titer
Interval 252.2 to 699.5
|
188.1 Titer
Interval 88.9 to 398.2
|
699.4 Titer
Interval 398.9 to 1226.4
|
675.6 Titer
Interval 343.2 to 1329.8
|
1024.0 Titer
Interval 509.4 to 2058.3
|
477.7 Titer
Interval 236.0 to 967.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 (1 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1
|
4674.1 Titer
Interval 3112.1 to 7020.2
|
2048.4 Titer
Interval 1007.8 to 4163.7
|
3327.0 Titer
Interval 1867.6 to 5926.9
|
3565.8 Titer
Interval 1992.1 to 6382.7
|
5404.7 Titer
Interval 3359.8 to 8694.1
|
2521.4 Titer
Interval 1388.9 to 4577.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 (1 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1
|
157.6 Titer
Interval 94.0 to 264.2
|
85.7 Titer
Interval 52.5 to 139.8
|
151.0 Titer
Interval 72.6 to 314.1
|
230.7 Titer
Interval 140.0 to 379.2
|
284.0 Titer
Interval 134.7 to 599.1
|
147.0 Titer
Interval 86.3 to 250.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 (3 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3
|
247.3 Titer
Interval 119.7 to 510.7
|
118.5 Titer
Interval 54.6 to 257.1
|
461.4 Titer
Interval 203.8 to 1044.7
|
711.0 Titer
Interval 388.8 to 1300.1
|
512.0 Titer
Interval 246.9 to 1061.6
|
285.6 Titer
Interval 132.8 to 614.1
|
—
|
—
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—
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—
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—
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—
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—
|
—
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—
|
—
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—
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—
|
PRIMARY outcome
Timeframe: Month 3 (3 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3
|
2896.3 Titer
Interval 1738.8 to 4824.3
|
1290.2 Titer
Interval 675.2 to 2465.3
|
2610.3 Titer
Interval 1265.9 to 5382.4
|
2949.6 Titer
Interval 1550.2 to 5612.3
|
2610.3 Titer
Interval 1506.5 to 4522.8
|
1474.8 Titer
Interval 815.0 to 2668.9
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 (3 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=19 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3
|
222.9 Titer
Interval 123.3 to 402.7
|
132.8 Titer
Interval 63.7 to 276.7
|
322.5 Titer
Interval 147.6 to 704.6
|
458.9 Titer
Interval 206.8 to 1018.6
|
296.2 Titer
Interval 143.2 to 612.6
|
141.3 Titer
Interval 86.4 to 231.1
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
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—
|
PRIMARY outcome
Timeframe: Month 6 (6 month after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6
|
239.6 Titer
Interval 98.8 to 581.4
|
229.5 Titer
Interval 68.7 to 766.4
|
1058.4 Titer
Interval 490.3 to 2284.6
|
1722.2 Titer
Interval 844.3 to 3512.9
|
588.1 Titer
Interval 280.3 to 1234.2
|
284.0 Titer
Interval 131.8 to 612.4
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (6 months after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6
|
1424.5 Titer
Interval 667.9 to 3037.9
|
1371.0 Titer
Interval 508.5 to 3696.4
|
2756.4 Titer
Interval 1328.0 to 5721.4
|
3956.5 Titer
Interval 2256.3 to 6937.8
|
2702.4 Titer
Interval 1457.6 to 5010.0
|
1097.5 Titer
Interval 555.3 to 2169.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (6 months after vaccination)Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6
|
203.2 Titer
Interval 85.5 to 483.1
|
265.5 Titer
Interval 75.9 to 928.9
|
645.1 Titer
Interval 281.1 to 1480.5
|
1305.2 Titer
Interval 601.1 to 2834.1
|
430.5 Titer
Interval 204.7 to 905.4
|
187.4 Titer
Interval 80.5 to 436.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination
|
3.5 Fold rise
Interval 2.1 to 5.8
|
2.9 Fold rise
Interval 1.6 to 5.4
|
6.8 Fold rise
Interval 4.3 to 10.7
|
8.6 Fold rise
Interval 5.1 to 14.3
|
4.3 Fold rise
Interval 2.0 to 9.1
|
9.8 Fold rise
Interval 6.9 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination
|
3.5 Fold rise
Interval 2.5 to 5.0
|
3.1 Fold rise
Interval 1.8 to 5.2
|
3.4 Fold rise
Interval 2.2 to 5.1
|
4.8 Fold rise
Interval 3.0 to 7.5
|
3.4 Fold rise
Interval 1.4 to 8.1
|
6.3 Fold rise
Interval 3.9 to 10.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=16 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination
|
2.8 Fold rise
Interval 2.1 to 3.7
|
2.8 Fold rise
Interval 1.8 to 4.4
|
3.6 Fold rise
Interval 2.5 to 5.2
|
3.2 Fold rise
Interval 2.2 to 4.8
|
2.9 Fold rise
Interval 1.9 to 4.4
|
4.7 Fold rise
Interval 3.4 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination
|
10.1 Fold rise
Interval 5.5 to 18.4
|
5.4 Fold rise
Interval 2.6 to 11.4
|
20.4 Fold rise
Interval 11.8 to 35.3
|
18.4 Fold rise
Interval 9.5 to 35.6
|
13.0 Fold rise
Interval 6.7 to 25.1
|
21.1 Fold rise
Interval 11.5 to 38.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination
|
8.6 Fold rise
Interval 5.5 to 13.6
|
5.0 Fold rise
Interval 2.5 to 10.0
|
7.2 Fold rise
Interval 4.7 to 10.9
|
11.3 Fold rise
Interval 6.2 to 20.8
|
6.7 Fold rise
Interval 3.7 to 12.1
|
8.6 Fold rise
Interval 4.1 to 17.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 1 month after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination
|
5.9 Fold rise
Interval 3.8 to 9.1
|
4.7 Fold rise
Interval 3.1 to 7.1
|
7.5 Fold rise
Interval 4.6 to 12.3
|
9.8 Fold rise
Interval 7.3 to 13.3
|
6.7 Fold rise
Interval 3.5 to 13.0
|
9.5 Fold rise
Interval 6.0 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 3 months after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination
|
5.9 Fold rise
Interval 2.7 to 12.8
|
3.3 Fold rise
Interval 1.4 to 7.5
|
13.5 Fold rise
Interval 6.0 to 30.0
|
17.9 Fold rise
Interval 8.7 to 36.5
|
6.5 Fold rise
Interval 3.2 to 13.1
|
12.0 Fold rise
Interval 6.4 to 22.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 3 months after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination
|
5.0 Fold rise
Interval 2.9 to 8.5
|
3.2 Fold rise
Interval 1.6 to 6.3
|
5.6 Fold rise
Interval 2.6 to 11.9
|
8.6 Fold rise
Interval 4.3 to 17.2
|
3.2 Fold rise
Interval 1.8 to 5.8
|
4.5 Fold rise
Interval 2.4 to 8.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 3 months after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=19 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination
|
8.6 Fold rise
Interval 4.3 to 16.9
|
7.4 Fold rise
Interval 3.7 to 14.9
|
16.0 Fold rise
Interval 7.5 to 34.0
|
18.5 Fold rise
Interval 9.2 to 37.3
|
7.2 Fold rise
Interval 4.1 to 12.7
|
9.4 Fold rise
Interval 5.9 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 6 months after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination
|
5.8 Fold rise
Interval 2.2 to 15.0
|
6.9 Fold rise
Interval 1.6 to 30.4
|
33.1 Fold rise
Interval 13.7 to 79.6
|
46.9 Fold rise
Interval 17.6 to 124.7
|
7.5 Fold rise
Interval 2.4 to 22.8
|
12.6 Fold rise
Interval 5.8 to 27.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 6 months after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination
|
2.6 Fold rise
Interval 1.1 to 6.1
|
3.6 Fold rise
Interval 1.0 to 12.7
|
6.3 Fold rise
Interval 2.6 to 15.2
|
12.6 Fold rise
Interval 6.0 to 26.1
|
3.4 Fold rise
Interval 1.3 to 8.9
|
3.9 Fold rise
Interval 1.8 to 8.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From before the study vaccination to 6 months after vaccinationPopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination
|
7.5 Fold rise
Interval 2.8 to 20.2
|
16.6 Fold rise
Interval 4.1 to 66.8
|
32.0 Fold rise
Interval 12.7 to 80.7
|
55.7 Fold rise
Interval 22.2 to 140.0
|
10.2 Fold rise
Interval 3.7 to 28.0
|
13.0 Fold rise
Interval 5.4 to 31.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse on Day 7 was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
44.4 Percentage of participants
Interval 21.5 to 69.2
|
71.4 Percentage of participants
Interval 47.8 to 88.7
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
90.0 Percentage of participants
Interval 68.3 to 98.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse on Day 7 was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
55.6 Percentage of participants
Interval 30.8 to 78.5
|
61.9 Percentage of participants
Interval 38.4 to 81.9
|
80.0 Percentage of participants
Interval 56.3 to 94.3
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
80.0 Percentage of participants
Interval 56.3 to 94.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 (7 days after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse on Day 7 was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=16 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
43.8 Percentage of participants
Interval 19.8 to 70.1
|
42.9 Percentage of participants
Interval 21.8 to 66.0
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
61.9 Percentage of participants
Interval 38.4 to 81.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 (1 month after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
61.1 Percentage of participants
Interval 35.7 to 82.7
|
90.0 Percentage of participants
Interval 68.3 to 98.8
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
90.0 Percentage of participants
Interval 68.3 to 98.8
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 (1 month after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1
|
81.0 Percentage of participants
Interval 58.1 to 94.6
|
61.1 Percentage of participants
Interval 35.7 to 82.7
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 (1 month after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
61.1 Percentage of participants
Interval 35.7 to 82.7
|
66.7 Percentage of participants
Interval 43.0 to 85.4
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
80.0 Percentage of participants
Interval 56.3 to 94.3
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 (3 months after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 3 months was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
84.2 Percentage of participants
Interval 60.4 to 96.6
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
89.5 Percentage of participants
Interval 66.9 to 98.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 (3 months after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 3 months was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=19 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
55.6 Percentage of participants
Interval 30.8 to 78.5
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
78.9 Percentage of participants
Interval 54.4 to 93.9
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
63.2 Percentage of participants
Interval 38.4 to 83.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 (3 months after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 3 months was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=20 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=19 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=19 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=21 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
61.1 Percentage of participants
Interval 35.7 to 82.7
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
84.2 Percentage of participants
Interval 60.4 to 96.6
|
63.2 Percentage of participants
Interval 38.4 to 83.7
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (6 months after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 6 months was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6
|
42.9 Percentage of participants
Interval 21.8 to 66.0
|
47.4 Percentage of participants
Interval 24.4 to 71.1
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
90.0 Percentage of participants
Interval 68.3 to 98.8
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (6 months after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 6 months was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=19 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6
|
42.9 Percentage of participants
Interval 21.8 to 66.0
|
42.1 Percentage of participants
Interval 20.3 to 66.5
|
61.9 Percentage of participants
Interval 38.4 to 81.9
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
55.0 Percentage of participants
Interval 31.5 to 76.9
|
50.0 Percentage of participants
Interval 27.2 to 72.8
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
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—
|
PRIMARY outcome
Timeframe: Month 6 (6 months after vaccination)Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 6 months was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=18 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
n=21 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 Participants
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=20 Participants
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=20 Participants
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
90.0 Percentage of participants
Interval 68.3 to 98.8
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.105 and for Placebo was 0.951Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'N' signifies participants evaluable for this outcome measure.
Occurrence (number of cases) of first severe COVID-19 infection based on FDA definition after booster dose without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate greater than or equal to \[\>=\]30 breaths per minute, heart rate \>= 125 beats per minute, oxygen saturation less than or equal to \[\<=\]93% on room air at sea level, or Horovitz quotient \<300 mmHg); 2) respiratory failure (needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic blood pressure \[BP\] \<90 mmHg, diastolic BP \<60 mmHg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4639 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4601 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population
|
0 Number of 1st severe Covid19cases/1000PY
|
2.103 Number of 1st severe Covid19cases/1000PY
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.182 and for Placebo was 1.011Population: Evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'N' signifies participants evaluable for this outcome measure.
Occurrence (number of cases) of first severe COVID-19 infection based on FDA definition after booster dose with and without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate \>= 30 breaths per minute, heart rate \>= 125 beats per minute, oxygen saturation \<= 93% on room air at sea level, or Horovitz quotient \<300 mm Hg); 2) respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic BP \<90 mm Hg, diastolic BP \<60 mm Hg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4911 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4861 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population
|
0 Number of 1st severe Covid19cases/1000PY
|
1.978 Number of 1st severe Covid19cases/1000PY
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 7 Days after booster vaccinationPopulation: Evaluable efficacy population included eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Occurrence (number of cases) of first severe COVID-19 infection based on CDC definition after booster dose without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 and presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4689 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4664 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection
|
0 Number of 1st severe Covid19cases/1000PY
|
0 Number of 1st severe Covid19cases/1000PY
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 7 Days after booster vaccinationPopulation: Evaluable efficacy population included eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Occurrence (number of cases) of first severe COVID-19 infection based on CDC definition after booster dose with and without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 AND presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=4977 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=4942 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection
|
0 Number of 1st severe Covid19cases/1000PY
|
0 Number of 1st severe Covid19cases/1000PY
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and 7 days after the booster dosePopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMT of SARS-CoV-2 reference-strain neutralizing titers at baseline and 7 days after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=52 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=47 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose
Baseline
|
1846.7 Titer
Interval 1232.1 to 2767.9
|
2230.4 Titer
Interval 1451.8 to 3426.7
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose
Day 7
|
15193.4 Titer
Interval 12335.9 to 18712.8
|
22689.7 Titer
Interval 18949.8 to 27167.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and 7 days after booster dosePopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable at specified timepoint.
GMT of SARS-CoV-2 Omicron BA.1- neutralizing titers at baseline and 7 days after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=52 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=47 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose
Baseline
|
68.2 Titer
Interval 39.1 to 119.1
|
131.1 Titer
Interval 68.7 to 250.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
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—
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—
|
—
|
—
|
—
|
|
SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose
Day 7
|
1356.4 Titer
Interval 970.1 to 1896.4
|
2655.7 Titer
Interval 2046.7 to 3445.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (before booster dose) to 7 days after the booster dosePopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline (before the booster dose) to 7 days after the booster dose was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=52 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=47 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 7 Days After the Booster Dose
|
8.2 Fold rise
Interval 5.9 to 11.5
|
10.2 Fold rise
Interval 6.8 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (before booster dose) to 7 days after the booster dosePopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
GMFR of SARS-CoV-2 Omicron BA.1-strain-neutralizing titers from baseline (before the booster dose) to 7 days after the booster dose was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=49 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=47 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
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SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline to 7 Days After the Booster Dose
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19.7 Fold rise
Interval 12.3 to 31.6
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20.2 Fold rise
Interval 11.7 to 35.0
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SECONDARY outcome
Timeframe: 7 days after the booster dosePopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from before booster dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse to reference strain at 7 days after the booster dose was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=52 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=47 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSC: Percentages of Participants With Seroresponse to Reference Strain at 7 Days After the Booster Dose
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71.2 Percentage of participants
Interval 56.9 to 82.9
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68.1 Percentage of participants
Interval 52.9 to 80.9
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SECONDARY outcome
Timeframe: 7 days after the booster dosePopulation: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Seroresponse was defined as achieving \>= 4-fold rise from before booster dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse to Omicron BA.1 strain at 7 days after the booster dose was reported in this outcome measure.
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=49 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=47 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
|
SSD: Cohort 1: Group 2b
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSC: Percentages of Participants With Seroresponse to Omicron BA.1 at 7 Days After the Booster Dose
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77.6 Percentage of participants
Interval 63.4 to 88.2
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74.5 Percentage of participants
Interval 59.7 to 86.1
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SECONDARY outcome
Timeframe: 1 month after study vaccinationPopulation: Evaluable immunogenicity population was analyzed. Participants without evidence of prior infection were included in the analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Participants were analyzed only in Expanded cohort \>55 years BNT162b2 30 mcg, BNT162b2 15 mcg + BNT162b2 OMI 15 mcg and BNT162b2 30 mcg + BNT162b2 OMI 30 mcg, as pre-specified in protocol.
GMR based on GMT of SARS-CoV-2 reference strain neutralizing titers was calculated and reported in statistical analysis section. GMT of SARS-CoV-2 Reference strain-neutralizing titers at 1 month after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSB: BNT162b2 30 mcg Then Placebo
n=182 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.
|
SSB: Placebo Then BNT162b2 30 mcg
n=186 Participants
Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.
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SSD: Cohort 1: Group 2b
n=180 Participants
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
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SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age
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5998.1 Titer
Interval 5223.6 to 6887.4
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5933.2 Titer
Interval 5188.2 to 6785.2
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7816.9 Titer
Interval 6820.7 to 8958.6
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Adverse Events
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
Serious events: 3 serious events
Other events: 431 other events
Deaths: 0 deaths
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Serious events: 2 serious events
Other events: 143 other events
Deaths: 0 deaths
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Serious events: 3 serious events
Other events: 297 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 1 deaths
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
Serious events: 6 serious events
Other events: 220 other events
Deaths: 0 deaths
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
Serious events: 2 serious events
Other events: 243 other events
Deaths: 0 deaths
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
Serious events: 12 serious events
Other events: 241 other events
Deaths: 1 deaths
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
Serious events: 4 serious events
Other events: 248 other events
Deaths: 1 deaths
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
Serious events: 4 serious events
Other events: 226 other events
Deaths: 0 deaths
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
Serious events: 6 serious events
Other events: 247 other events
Deaths: 1 deaths
SSD: Cohort 3: Group 5b
Serious events: 1 serious events
Other events: 69 other events
Deaths: 1 deaths
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
SSD: Cohort 1: Group 2a
Serious events: 3 serious events
Other events: 131 other events
Deaths: 2 deaths
SSD: Cohort 1: Group 2b
Serious events: 2 serious events
Other events: 109 other events
Deaths: 1 deaths
SSD: Cohort 2: Group 3a
Serious events: 5 serious events
Other events: 260 other events
Deaths: 1 deaths
SSD: Cohort 2: Group 3 b
Serious events: 1 serious events
Other events: 167 other events
Deaths: 0 deaths
SSD: Cohort 2: Group 4a
Serious events: 2 serious events
Other events: 270 other events
Deaths: 0 deaths
SSD: Cohort 2: Group 4b
Serious events: 3 serious events
Other events: 175 other events
Deaths: 0 deaths
SSD: Cohort 3: Group 5a
Serious events: 7 serious events
Other events: 135 other events
Deaths: 1 deaths
SSA: BNT162b2 30 mcg- Blinded and Open Label Period
Serious events: 73 serious events
Other events: 1201 other events
Deaths: 5 deaths
SSA: Placebo: Blinded Period
Serious events: 42 serious events
Other events: 202 other events
Deaths: 2 deaths
SSA: Original Placebo/BNT162b2 (30 mcg)- Open Label Period
Serious events: 45 serious events
Other events: 771 other events
Deaths: 5 deaths
SSB: BNT162b2
Serious events: 2 serious events
Other events: 1180 other events
Deaths: 0 deaths
SSB: Placebo
Serious events: 2 serious events
Other events: 615 other events
Deaths: 0 deaths
SSF: BNT162b2 30 mcg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
SSF: BNT162b2 60 mcg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
SSF: BNT162b2 OMI 30 mcg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
SSF: BNT162b2 OMI 60 mcg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
SSC: BNT162b2 10 mcg
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
SSC: BNT162b2 30 mcg
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
SSD: Cohort 1: Group 1
Serious events: 2 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=482 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=159 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=321 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 participants at risk
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 participants at risk
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=305 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=302 participants at risk
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=307 participants at risk
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=307 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=308 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=313 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 3: Group 5b
n=172 participants at risk
Subjects upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination (Vaccination 3).
|
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
n=30 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=30 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=30 participants at risk
Participants received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2a
n=197 participants at risk
Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2b
n=204 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 2: Group 3a
n=315 participants at risk
Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm (Vaccination 1).
|
SSD: Cohort 2: Group 3 b
n=213 participants at risk
After 3 months of Vaccination 1, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI (Vaccination 2).
|
SSD: Cohort 2: Group 4a
n=323 participants at risk
Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm (Vaccination 1).
|
SSD: Cohort 2: Group 4b
n=238 participants at risk
After 3 months of Vaccination 1, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI (Vaccination 2).
|
SSD: Cohort 3: Group 5a
n=210 participants at risk
Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm (Vaccination 1 and 2).
|
SSA: BNT162b2 30 mcg- Blinded and Open Label Period
n=5080 participants at risk
Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: Placebo: Blinded Period
n=5041 participants at risk
Participants received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly.
|
SSA: Original Placebo/BNT162b2 (30 mcg)- Open Label Period
n=4429 participants at risk
Subjects received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSB: BNT162b2
n=1453 participants at risk
Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSB: Placebo
n=1463 participants at risk
Subjects received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly.
|
SSF: BNT162b2 30 mcg
n=21 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 60 mcg
n=19 participants at risk
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 30 mcg
n=21 participants at risk
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 60 mcg
n=20 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
n=20 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
n=21 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 10 mcg
n=75 participants at risk
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 30 mcg
n=65 participants at risk
Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 1
n=216 participants at risk
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/308 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.51%
1/197 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5080 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.96%
3/313 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5080 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.05%
2/4429 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.04%
2/5080 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Endocrine disorders
Goitre
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.05%
2/4429 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Chest pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Death
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Immune system disorders
Food allergy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
1/238 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Appendicitis perforated
|
0.21%
1/482 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5080 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
COVID-19
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.49%
1/204 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.63%
1/159 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.07%
1/1453 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Device related infection
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/313 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.05%
2/4429 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Infection
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.66%
2/305 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Septic shock
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.04%
2/5080 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/305 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.09%
4/4429 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.21%
1/482 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/305 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.04%
2/5080 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage II
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system neoplasm
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/308 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5080 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vagina
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
1/238 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.04%
2/5080 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Seizure
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.31%
1/321 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5080 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Toxic leukoencephalopathy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.04%
2/5080 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.07%
1/1463 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.46%
1/216 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.04%
2/5041 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.05%
2/4429 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5080 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.3%
1/19 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5041 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5080 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Empyema
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/4429 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.07%
1/1453 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcomas
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.07%
1/1463 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Migraine
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.07%
1/1453 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.8%
1/21 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
1/65 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.51%
1/197 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.0%
2/197 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.49%
1/204 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.46%
1/216 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.51%
1/197 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/313 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/313 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
1/238 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.31%
1/323 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/305 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.47%
1/213 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/64 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
1/238 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.31%
1/323 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.58%
1/172 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
1/210 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/313 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/305 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/308 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/308 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Gangrene
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/305 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/308 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/302 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/307 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.33%
1/302 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.21%
1/482 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.31%
1/321 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.31%
1/321 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.63%
1/159 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
Other adverse events
| Measure |
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=482 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=159 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=321 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg
n=20 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg
n=20 participants at risk
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=20 participants at risk
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=20 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=20 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=20 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg
n=305 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg
n=302 participants at risk
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg
n=307 participants at risk
Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg
n=307 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg
n=308 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg
n=313 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 3: Group 5b
n=172 participants at risk
Subjects upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination (Vaccination 3).
|
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg
n=30 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg
n=30 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg
n=30 participants at risk
Participants received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2a
n=197 participants at risk
Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 2b
n=204 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 2: Group 3a
n=315 participants at risk
Subjects received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm (Vaccination 1).
|
SSD: Cohort 2: Group 3 b
n=213 participants at risk
After 3 months of Vaccination 1, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI (Vaccination 2).
|
SSD: Cohort 2: Group 4a
n=323 participants at risk
Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm (Vaccination 1).
|
SSD: Cohort 2: Group 4b
n=238 participants at risk
After 3 months of Vaccination 1, subjects upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI (Vaccination 2).
|
SSD: Cohort 3: Group 5a
n=210 participants at risk
Subjects received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm (Vaccination 1 and 2).
|
SSA: BNT162b2 30 mcg- Blinded and Open Label Period
n=5080 participants at risk
Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSA: Placebo: Blinded Period
n=5041 participants at risk
Participants received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly.
|
SSA: Original Placebo/BNT162b2 (30 mcg)- Open Label Period
n=4429 participants at risk
Subjects received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly and then one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSB: BNT162b2
n=1453 participants at risk
Subjects received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSB: Placebo
n=1463 participants at risk
Subjects received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly.
|
SSF: BNT162b2 30 mcg
n=21 participants at risk
Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 60 mcg
n=19 participants at risk
Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 30 mcg
n=21 participants at risk
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 OMI 60 mcg
n=20 participants at risk
Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg
n=20 participants at risk
Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
n=21 participants at risk
Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 10 mcg
n=75 participants at risk
Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSC: BNT162b2 30 mcg
n=65 participants at risk
Subjects received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.
|
SSD: Cohort 1: Group 1
n=216 participants at risk
Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
7/482 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.9%
3/159 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
4/321 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
2/30 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
4/323 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
1/238 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.8%
141/5080 • Number of events 147 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.06%
3/5041 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
59/4429 • Number of events 59 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.1%
54/5080 • Number of events 54 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
16/5041 • Number of events 16 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Chills
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.9%
4/213 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
1/238 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.8%
243/5080 • Number of events 243 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.22%
11/5041 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.4%
107/4429 • Number of events 107 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Fatigue
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.63%
2/315 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.8%
6/213 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.1%
5/238 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.5%
383/5080 • Number of events 383 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
66/5041 • Number of events 66 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.1%
228/4429 • Number of events 228 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Injection site pain
|
0.62%
3/482 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
4/321 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.9%
4/213 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.31%
1/323 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
3/238 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.9%
6/210 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.2%
673/5080 • Number of events 675 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.6%
83/5041 • Number of events 83 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.3%
412/4429 • Number of events 412 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
17/1453 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.21%
3/1463 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.7%
139/5080 • Number of events 140 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
16/5041 • Number of events 16 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.8%
122/4429 • Number of events 122 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Pyrexia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.1%
258/5080 • Number of events 258 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.16%
8/5041 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.2%
142/4429 • Number of events 143 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.63%
2/315 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.9%
4/213 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.9%
248/5080 • Number of events 248 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.42%
21/5041 • Number of events 21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.7%
118/4429 • Number of events 119 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.1%
58/5080 • Number of events 58 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.02%
1/5041 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.8%
1/21 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
2/172 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
3/197 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.49%
1/204 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.32%
1/315 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.94%
2/213 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.7%
4/238 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.9%
4/210 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.3%
267/5080 • Number of events 269 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.1%
54/5041 • Number of events 54 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
144/4429 • Number of events 144 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.8%
1/21 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.46%
1/216 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
12.7%
61/482 • Number of events 61 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.7%
17/159 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
12.1%
39/321 • Number of events 39 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.3%
13/305 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.6%
17/302 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.8%
24/307 • Number of events 24 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.1%
31/307 • Number of events 31 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.4%
26/308 • Number of events 26 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
21/313 • Number of events 21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.7%
3/172 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
6/30 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.3%
4/30 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.2%
20/197 • Number of events 24 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.4%
13/204 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.9%
25/315 • Number of events 25 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.5%
18/213 • Number of events 18 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.8%
35/323 • Number of events 35 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.5%
13/238 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.5%
20/210 • Number of events 24 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.5%
109/1453 • Number of events 109 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.3%
77/1463 • Number of events 77 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.3%
1/19 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.5%
2/21 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.0%
3/75 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.2%
6/65 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.8%
19/216 • Number of events 19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
3.1%
15/482 • Number of events 15 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.63%
1/159 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.7%
12/321 • Number of events 12 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
4/305 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.7%
5/302 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.9%
9/307 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.6%
8/307 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
4/308 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
4/313 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.3%
4/172 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.1%
8/197 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.4%
7/204 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.5%
8/315 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.47%
1/213 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
5/323 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.7%
4/238 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
7/210 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.5%
37/1453 • Number of events 37 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.89%
13/1463 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
1/75 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.1%
2/65 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.93%
2/216 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Chills (CHILLS)
|
35.5%
171/482 • Number of events 171 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
27.7%
44/159 • Number of events 44 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
38.3%
123/321 • Number of events 123 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.0%
7/20 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.0%
5/20 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
6/20 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
16.1%
49/305 • Number of events 49 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.8%
72/302 • Number of events 72 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.1%
77/307 • Number of events 77 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.4%
78/307 • Number of events 78 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
12.3%
38/308 • Number of events 38 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.6%
74/313 • Number of events 74 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.1%
14/172 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.3%
7/30 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.3%
7/30 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
40.0%
12/30 • Number of events 12 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
17.8%
35/197 • Number of events 39 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.3%
21/204 • Number of events 21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
29.5%
93/315 • Number of events 93 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
18.3%
39/213 • Number of events 39 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
24.8%
80/323 • Number of events 80 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
17.2%
41/238 • Number of events 41 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.2%
32/210 • Number of events 36 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
19.1%
278/1453 • Number of events 278 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.7%
69/1463 • Number of events 69 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.8%
3/19 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.8%
5/21 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.0%
5/20 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.3%
10/75 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.1%
15/65 • Number of events 15 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.4%
31/216 • Number of events 31 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Fatigue (FATIGUE)
|
73.4%
354/482 • Number of events 354 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
67.9%
108/159 • Number of events 108 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
77.3%
248/321 • Number of events 248 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
45.0%
9/20 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
55.0%
11/20 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
45.0%
9/20 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
65.0%
13/20 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
40.0%
8/20 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
70.0%
14/20 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
44.3%
135/305 • Number of events 135 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
51.7%
156/302 • Number of events 156 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
51.5%
158/307 • Number of events 158 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
57.7%
177/307 • Number of events 177 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
47.7%
147/308 • Number of events 147 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
56.5%
177/313 • Number of events 177 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.3%
35/172 • Number of events 35 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
66.7%
20/30 • Number of events 20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
63.3%
19/30 • Number of events 19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
70.0%
21/30 • Number of events 21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
31.0%
61/197 • Number of events 79 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
27.9%
57/204 • Number of events 57 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
60.0%
189/315 • Number of events 189 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
55.9%
119/213 • Number of events 119 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
57.0%
184/323 • Number of events 184 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
49.2%
117/238 • Number of events 117 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
41.4%
87/210 • Number of events 109 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
49.8%
723/1453 • Number of events 723 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
24.3%
356/1463 • Number of events 356 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
47.6%
10/21 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
36.8%
7/19 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
42.9%
9/21 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
55.0%
11/20 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
50.0%
10/20 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
57.1%
12/21 • Number of events 12 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
49.3%
37/75 • Number of events 37 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
53.8%
35/65 • Number of events 35 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
31.0%
67/216 • Number of events 67 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Injection site erythema (REDNESS)
|
8.1%
39/482 • Number of events 39 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.3%
10/159 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.9%
35/321 • Number of events 35 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.2%
19/305 • Number of events 19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.3%
31/302 • Number of events 31 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.2%
19/307 • Number of events 19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.7%
33/307 • Number of events 33 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.1%
22/308 • Number of events 22 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.0%
22/313 • Number of events 22 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.1%
7/172 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
2/30 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
2/30 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.1%
18/197 • Number of events 20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.5%
5/204 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
21/315 • Number of events 21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.7%
10/213 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.0%
13/323 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.8%
9/238 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
14/210 • Number of events 16 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.1%
74/1453 • Number of events 74 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.62%
9/1463 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
19.0%
4/21 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
21.1%
4/19 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.8%
5/21 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
28.6%
6/21 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
1/75 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.2%
4/65 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.2%
7/216 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Injection site pain (PAIN)
|
82.6%
398/482 • Number of events 398 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
80.5%
128/159 • Number of events 128 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
86.0%
276/321 • Number of events 276 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
70.0%
14/20 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
70.0%
14/20 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
65.0%
13/20 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
100.0%
20/20 • Number of events 20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
65.0%
13/20 • Number of events 131 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
85.0%
17/20 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
58.7%
179/305 • Number of events 179 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
70.2%
212/302 • Number of events 212 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
64.8%
199/307 • Number of events 199 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
69.7%
214/307 • Number of events 214 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
57.5%
177/308 • Number of events 177 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
66.5%
208/313 • Number of events 208 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
34.9%
60/172 • Number of events 60 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
90.0%
27/30 • Number of events 27 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
83.3%
25/30 • Number of events 25 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
96.7%
29/30 • Number of events 29 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
55.8%
110/197 • Number of events 145 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
41.7%
85/204 • Number of events 85 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
72.7%
229/315 • Number of events 229 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
68.1%
145/213 • Number of events 145 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
74.0%
239/323 • Number of events 239 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
64.3%
153/238 • Number of events 153 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
51.9%
109/210 • Number of events 146 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
71.4%
1038/1453 • Number of events 1038 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
11.1%
163/1463 • Number of events 163 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
71.4%
15/21 • Number of events 15 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
94.7%
18/19 • Number of events 18 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
90.5%
19/21 • Number of events 19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
80.0%
16/20 • Number of events 16 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
75.0%
15/20 • Number of events 15 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
90.5%
19/21 • Number of events 19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
56.0%
42/75 • Number of events 42 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
76.9%
50/65 • Number of events 50 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
44.4%
96/216 • Number of events 96 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Injection site swelling (SWELLING)
|
9.5%
46/482 • Number of events 46 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.9%
11/159 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
11.8%
38/321 • Number of events 38 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.9%
18/305 • Number of events 18 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
12.9%
39/302 • Number of events 39 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.1%
25/307 • Number of events 25 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.1%
31/307 • Number of events 31 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.5%
20/308 • Number of events 20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.4%
17/313 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.3%
16/172 • Number of events 16 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.7%
2/30 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
6/30 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
11.7%
23/197 • Number of events 28 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.4%
11/204 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.9%
25/315 • Number of events 25 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.8%
8/213 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.4%
27/323 • Number of events 27 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.9%
14/238 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
12.9%
27/210 • Number of events 32 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.9%
86/1453 • Number of events 86 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.48%
7/1463 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.8%
3/19 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
28.6%
6/21 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.7%
2/75 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.2%
6/65 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.9%
17/216 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Pyrexia (FEVER)
|
10.0%
48/482 • Number of events 48 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.7%
17/159 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
19.3%
62/321 • Number of events 62 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.6%
11/305 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.3%
22/302 • Number of events 22 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.1%
25/307 • Number of events 25 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.8%
27/307 • Number of events 27 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.9%
15/308 • Number of events 15 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.7%
24/313 • Number of events 24 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
2.3%
4/172 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.3%
4/30 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
3/30 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.6%
7/197 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.9%
10/204 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
7.9%
25/315 • Number of events 25 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.2%
9/213 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.8%
22/323 • Number of events 22 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.5%
13/238 • Number of events 13 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.2%
11/210 • Number of events 12 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.1%
74/1453 • Number of events 74 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
17/1463 • Number of events 17 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.5%
2/21 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.5%
2/19 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.5%
2/21 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.8%
1/21 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
4.0%
3/75 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.2%
4/65 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.6%
12/216 • Number of events 12 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.2%
18/1453 • Number of events 18 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.8%
26/1463 • Number of events 26 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
25.3%
122/482 • Number of events 122 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.8%
33/159 • Number of events 33 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
24.0%
77/321 • Number of events 77 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.0%
5/20 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.0%
7/20 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.9%
27/305 • Number of events 27 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.9%
48/302 • Number of events 48 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
16.3%
50/307 • Number of events 50 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
19.2%
59/307 • Number of events 59 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
11.0%
34/308 • Number of events 34 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
18.2%
57/313 • Number of events 57 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
8.1%
14/172 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
6/30 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
16.7%
5/30 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.3%
7/30 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
16.8%
33/197 • Number of events 38 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.8%
20/204 • Number of events 20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
21.9%
69/315 • Number of events 69 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.1%
28/213 • Number of events 28 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.2%
46/323 • Number of events 46 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.9%
26/238 • Number of events 26 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.8%
29/210 • Number of events 30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
12.3%
178/1453 • Number of events 178 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.8%
55/1463 • Number of events 55 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.8%
3/19 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.3%
3/21 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.0%
2/20 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
9.5%
2/21 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
10.6%
23/216 • Number of events 23 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
39.6%
191/482 • Number of events 191 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
36.5%
58/159 • Number of events 58 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
42.1%
135/321 • Number of events 135 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.0%
5/20 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.0%
5/20 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.0%
7/20 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.0%
7/20 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
19.3%
59/305 • Number of events 59 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.2%
76/302 • Number of events 76 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.5%
72/307 • Number of events 72 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
92/307 • Number of events 92 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
22.7%
70/308 • Number of events 70 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
26.2%
82/313 • Number of events 82 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.4%
23/172 • Number of events 23 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
9/30 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
9/30 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
46.7%
14/30 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.8%
41/197 • Number of events 48 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
13.7%
28/204 • Number of events 28 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
31.4%
99/315 • Number of events 99 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.9%
51/213 • Number of events 51 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
26.6%
86/323 • Number of events 86 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
24.4%
58/238 • Number of events 58 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
21.4%
45/210 • Number of events 48 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
27.7%
402/1453 • Number of events 402 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
6.0%
88/1463 • Number of events 88 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
19.0%
4/21 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
42.1%
8/19 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.8%
5/21 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
6/20 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.0%
5/20 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
28.6%
6/21 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
14.8%
32/216 • Number of events 32 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Headache (HEADACHE)
|
53.3%
257/482 • Number of events 257 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
49.7%
79/159 • Number of events 79 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
57.3%
184/321 • Number of events 184 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
20.0%
4/20 • Number of events 4 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
6/20 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.0%
7/20 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
15.0%
3/20 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
6/20 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
50.0%
10/20 • Number of events 10 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
25.9%
79/305 • Number of events 79 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
38.4%
116/302 • Number of events 116 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.8%
110/307 • Number of events 110 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.8%
110/307 • Number of events 110 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
32.1%
99/308 • Number of events 99 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
36.4%
114/313 • Number of events 114 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
22.7%
39/172 • Number of events 39 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
46.7%
14/30 • Number of events 14 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
30.0%
9/30 • Number of events 9 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
60.0%
18/30 • Number of events 18 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.5%
70/197 • Number of events 89 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
27.0%
55/204 • Number of events 55 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
44.4%
140/315 • Number of events 140 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
36.6%
78/213 • Number of events 78 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
42.4%
137/323 • Number of events 137 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
34.0%
81/238 • Number of events 81 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
31.9%
67/210 • Number of events 77 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
40.3%
585/1453 • Number of events 585 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
22.7%
332/1463 • Number of events 332 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
28.6%
6/21 • Number of events 6 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
26.3%
5/19 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
23.8%
5/21 • Number of events 5 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
55.0%
11/20 • Number of events 11 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
35.0%
7/20 • Number of events 7 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
38.1%
8/21 • Number of events 8 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
41.3%
31/75 • Number of events 31 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
52.3%
34/65 • Number of events 34 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
29.6%
64/216 • Number of events 64 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Eye disorders
Eye pruritis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.3%
1/19 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
1/65 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
1/65 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Ear infections
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
1/75 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
1/75 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Attention deficit-hyperactivity disorder
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.1%
2/65 • Number of events 2 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
1/65 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.3%
1/75 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.5%
1/65 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Injection site swelling
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
1.4%
3/210 • Number of events 3 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Axillary pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Swelling
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
3.3%
1/30 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
General disorders
Feeling abnormal
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Infections and infestations
Skin infection
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/482 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/159 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/321 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
5.0%
1/20 • Number of events 1 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/305 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/302 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/307 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/308 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/313 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/172 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/30 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/197 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/204 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/315 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/213 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/323 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/238 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/210 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5080 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/5041 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/4429 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1453 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/1463 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/19 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/20 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/21 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/75 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/65 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
0.00%
0/216 • Death/SAEs: 6 months after last dose (or 1 month after each dose for SSB, or 6 months after BNT162b2 for SSA original placebo). Non-SAEs: 1 month after each booster dose (or after Dose 2 for SSD naïve group, or after BNT162b2 for SSA original placebo)
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. For SSB, SSC, SSE and SSF, MedDRA version used is v25.1. For SSD, MedDRA version used is v26.0.
|
Additional Information
BioNTech SE
BioNTech clinical trials patient information
Phone: +49 6131 90840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER