Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants (NCT NCT04713553)

Results Overview

Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1574 participants

Primary outcome timeframe

1 Month after Dose 2

Results posted on

2022-12-22

Participant Flow

This study was conducted in two parts: primary study and booster study.

Total number of participants enrolled in study and assigned to study intervention were 1574, however, only 1573 participants received study intervention.

Participant milestones

Participant milestones
Measure	BNT162b2 30 mcg: US Lot 1 Participants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: Booster Dose Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.	BNT162b2.B.1.351 30 mcg: Booster Dose Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Primary Study (2 Months) STARTED	351	352	347	173	351	0	0
Primary Study (2 Months) Treated	351	352	346	173	351	0	0
Primary Study (2 Months) COMPLETED	347	346	344	171	349	0	0
Primary Study (2 Months) NOT COMPLETED	4	6	3	2	2	0	0
Booster Study (1 Month) STARTED	0	0	0	0	0	31	31
Booster Study (1 Month) COMPLETED	0	0	0	0	0	31	31
Booster Study (1 Month) NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BNT162b2 30 mcg: US Lot 1 Participants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Primary Study (2 Months) Withdrawal by Subject	2	3	0	0	1
Primary Study (2 Months) Withdrawal by parent/guardian	0	0	0	1	0
Primary Study (2 Months) Other	1	2	0	0	1
Primary Study (2 Months) Lost to Follow-up	1	1	2	1	0
Primary Study (2 Months) Inclusion criteria not met	0	0	1	0	0

Baseline Characteristics

A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BNT162b2 30 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=346 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Total n=1573 Participants Total of all reporting groups
Age, Continuous	28.0 Years STANDARD_DEVIATION 11.66 • n=5 Participants	27.8 Years STANDARD_DEVIATION 11.76 • n=7 Participants	27.5 Years STANDARD_DEVIATION 11.54 • n=5 Participants	27.7 Years STANDARD_DEVIATION 11.40 • n=4 Participants	27.5 Years STANDARD_DEVIATION 11.71 • n=21 Participants	27.7 Years STANDARD_DEVIATION 11.63 • n=10 Participants
Sex: Female, Male Female	177 Participants n=5 Participants	176 Participants n=7 Participants	159 Participants n=5 Participants	83 Participants n=4 Participants	163 Participants n=21 Participants	758 Participants n=10 Participants
Sex: Female, Male Male	174 Participants n=5 Participants	176 Participants n=7 Participants	187 Participants n=5 Participants	90 Participants n=4 Participants	188 Participants n=21 Participants	815 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants	32 Participants n=7 Participants	55 Participants n=5 Participants	22 Participants n=4 Participants	42 Participants n=21 Participants	195 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	306 Participants n=5 Participants	319 Participants n=7 Participants	291 Participants n=5 Participants	151 Participants n=4 Participants	309 Participants n=21 Participants	1376 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants
Race (NIH/OMB) Asian	36 Participants n=5 Participants	48 Participants n=7 Participants	40 Participants n=5 Participants	24 Participants n=4 Participants	44 Participants n=21 Participants	192 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants	68 Participants n=10 Participants
Race (NIH/OMB) White	286 Participants n=5 Participants	280 Participants n=7 Participants	283 Participants n=5 Participants	142 Participants n=4 Participants	283 Participants n=21 Participants	1274 Participants n=10 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants

PRIMARY outcome

Timeframe: 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=324 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=311 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=310 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study	6299.5 Unit per milliliter 95% Confidence Interval 5835.4 • Interval 5835.4 to 6800.5	6231.9 Unit per milliliter 95% Confidence Interval 5763.7 • Interval 5763.7 to 6738.2	6774.8 Unit per milliliter 95% Confidence Interval 6264.9 • Interval 6264.9 to 7326.1	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

Geometric mean concentration of full-length S-binding IgG level for EU lot and pooled US lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm) were determined and reported in the descriptive section. Assay results below the LLOQ were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratios of GMCs of BNT162b2 30 mcg: EU Lot and pooled US Lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm).

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=160 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=945 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study	6098.6 Unit per milliliter Interval 5474.7 to 6793.7	6428.8 Unit per milliliter Interval 6149.5 to 6720.7	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

Geometric mean titer for SARS-CoV-2 neutralizing titers for 20 mcg dose and 30 mcg dose of US Lot 1 was determined and reported in the descriptive section. GMTs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) mean of the titers and corresponding CIs based on linear regression model. Assay results below the LLOQ were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and were calculated as the ratio of geometric mean titer of the 20-mcg dose (US Lot 1) to the geometric mean titer of the 30 mcg dose (US Lot 1).

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=318 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=324 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study	906.3 Titer Interval 847.8 to 968.9	976.6 Titer Interval 914.1 to 1043.4	—	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after Dose 1

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 1. Redness, swelling, and pain at injection site after Dose 1 were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=345 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1048 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Redness	1.1 Percentage of participants Interval 0.3 to 2.9	2.0 Percentage of participants Interval 0.8 to 4.1	2.9 Percentage of participants Interval 1.4 to 5.3	2.0 Percentage of participants Interval 1.2 to 3.0	2.3 Percentage of participants Interval 0.6 to 5.8	2.0 Percentage of participants Interval 0.8 to 4.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Swelling	2.0 Percentage of participants Interval 0.8 to 4.1	3.7 Percentage of participants Interval 2.0 to 6.2	3.8 Percentage of participants Interval 2.0 to 6.4	3.1 Percentage of participants Interval 2.2 to 4.4	2.9 Percentage of participants Interval 0.9 to 6.6	3.4 Percentage of participants Interval 1.8 to 5.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Pain at Injection Site	82.9 Percentage of participants Interval 78.6 to 86.7	79.3 Percentage of participants Interval 74.6 to 83.4	84.6 Percentage of participants Interval 80.4 to 88.3	82.3 Percentage of participants Interval 79.8 to 84.5	86.1 Percentage of participants Interval 80.1 to 90.9	78.1 Percentage of participants Interval 73.4 to 82.3

PRIMARY outcome

Timeframe: Within 7 days after Dose 2

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 2. Redness, swelling, and pain at injection site after Dose 2 were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=349 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=350 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=343 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1042 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=172 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=348 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Redness	3.7 Percentage of participants Interval 2.0 to 6.3	4.0 Percentage of participants Interval 2.2 to 6.6	4.4 Percentage of participants Interval 2.5 to 7.1	4.0 Percentage of participants Interval 2.9 to 5.4	2.9 Percentage of participants Interval 1.0 to 6.7	3.2 Percentage of participants Interval 1.6 to 5.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Swelling	4.9 Percentage of participants Interval 2.9 to 7.7	6.0 Percentage of participants Interval 3.8 to 9.0	4.7 Percentage of participants Interval 2.7 to 7.5	5.2 Percentage of participants Interval 3.9 to 6.7	3.5 Percentage of participants Interval 1.3 to 7.4	3.7 Percentage of participants Interval 2.0 to 6.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Pain at Injection Site	80.2 Percentage of participants Interval 75.7 to 84.3	77.7 Percentage of participants Interval 73.0 to 82.0	83.1 Percentage of participants Interval 78.7 to 86.9	80.3 Percentage of participants Interval 77.8 to 82.7	77.3 Percentage of participants Interval 70.3 to 83.4	79.6 Percentage of participants Interval 75.0 to 83.7

PRIMARY outcome

Timeframe: Within 7 days after any dose

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3).

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. Redness, swelling, and pain at injection site after any dose were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=347 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1049 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study Redness	4.6 Percentage of participants Interval 2.6 to 7.3	5.4 Percentage of participants Interval 3.3 to 8.3	6.6 Percentage of participants Interval 4.2 to 9.8	5.5 Percentage of participants Interval 4.2 to 7.1	4.6 Percentage of participants Interval 2.0 to 8.9	4.6 Percentage of participants Interval 2.6 to 7.3
Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study Swelling	6.0 Percentage of participants Interval 3.7 to 9.0	8.8 Percentage of participants Interval 6.1 to 12.3	7.2 Percentage of participants Interval 4.7 to 10.5	7.3 Percentage of participants Interval 5.8 to 9.1	4.6 Percentage of participants Interval 2.0 to 8.9	6.3 Percentage of participants Interval 4.0 to 9.3
Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study Pain at Injection Site	90.9 Percentage of participants Interval 87.4 to 93.7	85.8 Percentage of participants Interval 81.7 to 89.3	91.1 Percentage of participants Interval 87.6 to 93.8	89.2 Percentage of participants Interval 87.2 to 91.0	91.3 Percentage of participants Interval 86.1 to 95.1	89.5 Percentage of participants Interval 85.8 to 92.5

PRIMARY outcome

Timeframe: Within 7 days after Dose 3

Population: Safety population included all randomized participants who received dose 3 of the study intervention.

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. Redness, swelling, and pain at injection site after Dose 3 were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=31 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=31 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study Redness	9.7 Percentage of participants 95% Confidence Interval 2.0 • Interval 2.0 to 25.8	3.2 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 16.7	—	—	—	—
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study Swelling	6.5 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 21.4	6.5 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 21.4	—	—	—	—
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study Pain at Injection site	90.3 Percentage of participants 95% Confidence Interval 74.2 • Interval 74.2 to 98.0	93.5 Percentage of participants 95% Confidence Interval 78.6 • Interval 78.6 to 99.2	—	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after Dose 1

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.

Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 1 were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=345 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1048 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Fever >=38.0 C	0.3 Percentage of participants Interval 0.0 to 1.6	0 Percentage of participants Interval 0.0 to 1.0	2.0 Percentage of participants Interval 0.8 to 4.1	0.8 Percentage of participants Interval 0.3 to 1.5	1.2 Percentage of participants Interval 0.1 to 4.1	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Fever >=38.0 C to 38.4 C	0.3 Percentage of participants Interval 0.0 to 1.6	0 Percentage of participants Interval 0.0 to 1.0	1.2 Percentage of participants Interval 0.3 to 2.9	0.5 Percentage of participants Interval 0.2 to 1.1	0.6 Percentage of participants Interval 0.0 to 3.2	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Fever >38.4 C to 38.9 C	0 Percentage of participants Interval 0.0 to 1.0	0 Percentage of participants Interval 0.0 to 1.0	0.6 Percentage of participants Interval 0.1 to 2.1	0.2 Percentage of participants Interval 0.0 to 0.7	0.6 Percentage of participants Interval 0.0 to 3.2	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Fever >38.9 C to 40.0 C	0 Percentage of participants Interval 0.0 to 1.0	0 Percentage of participants Interval 0.0 to 1.0	0.3 Percentage of participants Interval 0.0 to 1.6	0.1 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 2.1	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Fever >40.0 C	0 Percentage of participants Interval 0.0 to 1.0	0 Percentage of participants Interval 0.0 to 1.0	1 Percentage of participants Interval 0.0 to 1.1	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 2.1	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Fatigue	53.3 Percentage of participants Interval 47.9 to 58.6	45.5 Percentage of participants Interval 40.2 to 50.8	50.7 Percentage of participants Interval 45.3 to 56.1	49.8 Percentage of participants Interval 46.7 to 52.9	49.1 Percentage of participants Interval 41.5 to 56.8	49.0 Percentage of participants Interval 43.7 to 54.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Headache	36.2 Percentage of participants Interval 31.1 to 41.5	32.7 Percentage of participants Interval 27.8 to 37.8	33.3 Percentage of participants Interval 28.4 to 38.6	34.1 Percentage of participants Interval 31.2 to 37.0	38.7 Percentage of participants Interval 31.4 to 46.4	35.6 Percentage of participants Interval 30.6 to 40.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Chills	8.5 Percentage of participants Interval 5.8 to 12.0	7.7 Percentage of participants Interval 5.1 to 11.0	10.1 Percentage of participants Interval 7.2 to 13.8	8.8 Percentage of participants Interval 7.1 to 10.7	8.1 Percentage of participants Interval 4.5 to 13.2	6.8 Percentage of participants Interval 4.4 to 10.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Vomiting	0.6 Percentage of participants Interval 0.1 to 2.0	0.6 Percentage of participants Interval 0.1 to 2.0	1.2 Percentage of participants Interval 0.3 to 2.9	0.8 Percentage of participants Interval 0.3 to 1.5	0.6 Percentage of participants Interval 0.0 to 3.2	0.9 Percentage of participants Interval 0.2 to 2.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Diarrhea	9.7 Percentage of participants Interval 6.8 to 13.3	8.0 Percentage of participants Interval 5.4 to 11.3	7.8 Percentage of participants Interval 5.2 to 11.2	8.5 Percentage of participants Interval 6.9 to 10.3	9.2 Percentage of participants Interval 5.4 to 14.6	10.0 Percentage of participants Interval 7.0 to 13.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study New/worsened muscle pain	14.5 Percentage of participants Interval 11.0 to 18.7	13.1 Percentage of participants Interval 9.7 to 17.0	16.5 Percentage of participants Interval 12.8 to 20.9	14.7 Percentage of participants Interval 12.6 to 17.0	17.3 Percentage of participants Interval 12.0 to 23.8	16.2 Percentage of participants Interval 12.5 to 20.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study New/worsened joint pain	6.8 Percentage of participants Interval 4.4 to 10.0	6.5 Percentage of participants Interval 4.2 to 9.6	7.0 Percentage of participants Interval 4.5 to 10.2	6.8 Percentage of participants Interval 5.3 to 8.5	7.5 Percentage of participants Interval 4.1 to 12.5	6.6 Percentage of participants Interval 4.2 to 9.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Use of antipyretic/analgesic medication	16.8 Percentage of participants Interval 13.0 to 21.1	14.5 Percentage of participants Interval 11.0 to 18.6	18.8 Percentage of participants Interval 14.9 to 23.4	16.7 Percentage of participants Interval 14.5 to 19.1	22.0 Percentage of participants Interval 16.0 to 28.9	18.2 Percentage of participants Interval 14.3 to 22.7

PRIMARY outcome

Timeframe: Within 7 days after Dose 2

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.

Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 C and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 2 were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=349 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=350 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=343 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1042 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=172 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=348 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Fever >38.4 C to 38.9 C	2.0 Percentage of participants Interval 0.8 to 4.1	2.0 Percentage of participants Interval 0.8 to 4.1	2.3 Percentage of participants Interval 1.0 to 4.5	2.1 Percentage of participants Interval 1.3 to 3.2	1.2 Percentage of participants Interval 0.1 to 4.1	1.4 Percentage of participants Interval 0.5 to 3.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Fever >40.0 C	0 Percentage of participants Interval 0.0 to 1.1	0 Percentage of participants Interval 0.0 to 1.0	0.3 Percentage of participants Interval 0.0 to 1.6	0.1 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 2.1	0 Percentage of participants Interval 0.0 to 2.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Diarrhea	8.3 Percentage of participants Interval 5.6 to 11.7	9.1 Percentage of participants Interval 6.3 to 12.7	7.9 Percentage of participants Interval 5.3 to 11.2	8.4 Percentage of participants Interval 6.8 to 10.3	9.3 Percentage of participants Interval 5.4 to 14.7	6.9 Percentage of participants Interval 4.5 to 10.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Use of antipyretic/analgesic medication	35.2 Percentage of participants Interval 30.2 to 40.5	41.1 Percentage of participants Interval 35.9 to 46.5	40.8 Percentage of participants Interval 35.6 to 46.2	39.1 Percentage of participants Interval 36.1 to 42.1	41.9 Percentage of participants Interval 34.4 to 49.6	37.9 Percentage of participants Interval 32.8 to 43.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Fever >=38.0 C	7.2 Percentage of participants Interval 4.7 to 10.4	6.3 Percentage of participants Interval 4.0 to 9.4	6.7 Percentage of participants Interval 4.3 to 9.9	6.7 Percentage of participants Interval 5.3 to 8.4	8.7 Percentage of participants Interval 5.0 to 14.0	5.7 Percentage of participants Interval 3.5 to 8.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Fever >=38.0 C to 38.4 C	4.6 Percentage of participants Interval 2.6 to 7.3	3.4 Percentage of participants Interval 1.8 to 5.9	3.2 Percentage of participants Interval 1.6 to 5.7	3.7 Percentage of participants Interval 2.7 to 5.1	6.4 Percentage of participants Interval 3.2 to 11.2	4.3 Percentage of participants Interval 2.4 to 7.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Fever >38.9 C to 40.0 C	0.6 Percentage of participants Interval 0.1 to 2.1	0.9 Percentage of participants Interval 0.2 to 2.5	0.9 Percentage of participants Interval 0.2 to 2.5	0.8 Percentage of participants Interval 0.3 to 1.5	1.2 Percentage of participants Interval 0.1 to 4.1	0 Percentage of participants Interval 0.0 to 1.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Fatigue	69.9 Percentage of participants Interval 64.8 to 74.7	66.6 Percentage of participants Interval 61.4 to 71.5	71.4 Percentage of participants Interval 66.3 to 76.2	69.3 Percentage of participants Interval 66.4 to 72.1	69.8 Percentage of participants Interval 62.3 to 76.5	66.7 Percentage of participants Interval 61.4 to 71.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Headache	57.0 Percentage of participants Interval 51.6 to 62.3	56.6 Percentage of participants Interval 51.2 to 61.8	56.9 Percentage of participants Interval 51.4 to 62.2	56.8 Percentage of participants Interval 53.7 to 59.8	56.4 Percentage of participants Interval 48.6 to 63.9	50.6 Percentage of participants Interval 45.2 to 55.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Chills	28.1 Percentage of participants Interval 23.4 to 33.1	31.1 Percentage of participants Interval 26.3 to 36.3	33.8 Percentage of participants Interval 28.8 to 39.1	31.0 Percentage of participants Interval 28.2 to 33.9	28.5 Percentage of participants Interval 21.9 to 35.9	23.6 Percentage of participants Interval 19.2 to 28.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Vomiting	2.3 Percentage of participants Interval 1.0 to 4.5	1.4 Percentage of participants Interval 0.5 to 3.3	2.3 Percentage of participants Interval 1.0 to 4.5	2.0 Percentage of participants Interval 1.3 to 3.1	1.7 Percentage of participants Interval 0.4 to 5.0	1.4 Percentage of participants Interval 0.5 to 3.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study New/worsened muscle pain	32.7 Percentage of participants Interval 27.8 to 37.9	38.6 Percentage of participants Interval 33.4 to 43.9	35.6 Percentage of participants Interval 30.5 to 40.9	35.6 Percentage of participants Interval 32.7 to 38.6	36.0 Percentage of participants Interval 28.9 to 43.7	35.6 Percentage of participants Interval 30.6 to 40.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study New/worsened joint pain	19.2 Percentage of participants Interval 15.2 to 23.7	24.6 Percentage of participants Interval 20.2 to 29.4	19.2 Percentage of participants Interval 15.2 to 23.8	21.0 Percentage of participants Interval 18.6 to 23.6	19.2 Percentage of participants Interval 13.6 to 25.9	19.5 Percentage of participants Interval 15.5 to 24.1

PRIMARY outcome

Timeframe: Within 7 days after any dose

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3).

Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 C and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after any dose were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=347 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1049 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Fever >38.9 C to 40.0 C	0.6 Percentage of participants Interval 0.1 to 2.0	0.9 Percentage of participants Interval 0.2 to 2.5	1.2 Percentage of participants Interval 0.3 to 2.9	0.9 Percentage of participants Interval 0.4 to 1.6	1.2 Percentage of participants Interval 0.1 to 4.1	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Vomiting	2.8 Percentage of participants Interval 1.4 to 5.2	2.0 Percentage of participants Interval 0.8 to 4.1	3.5 Percentage of participants Interval 1.8 to 6.0	2.8 Percentage of participants Interval 1.9 to 3.9	2.3 Percentage of participants Interval 0.6 to 5.8	2.3 Percentage of participants Interval 1.0 to 4.4
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Use of antipyretic/analgesic medication	41.9 Percentage of participants Interval 36.7 to 47.2	43.8 Percentage of participants Interval 38.5 to 49.1	46.4 Percentage of participants Interval 41.1 to 51.8	44.0 Percentage of participants Interval 41.0 to 47.1	51.4 Percentage of participants Interval 43.7 to 59.1	43.6 Percentage of participants Interval 38.3 to 49.0
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Fever >=38.0 C	7.4 Percentage of participants Interval 4.9 to 10.7	6.3 Percentage of participants Interval 4.0 to 9.3	8.4 Percentage of participants Interval 5.7 to 11.8	7.3 Percentage of participants Interval 5.8 to 9.1	9.2 Percentage of participants Interval 5.4 to 14.6	5.7 Percentage of participants Interval 3.5 to 8.7
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Fever >=38.0 C to 38.4 C	4.8 Percentage of participants Interval 2.8 to 7.6	3.4 Percentage of participants Interval 1.8 to 5.9	4.0 Percentage of participants Interval 2.2 to 6.7	4.1 Percentage of participants Interval 3.0 to 5.5	6.4 Percentage of participants Interval 3.2 to 11.1	4.3 Percentage of participants Interval 2.4 to 7.0
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Fever >38.4 C to 38.9 C	2.0 Percentage of participants Interval 0.8 to 4.1	2.0 Percentage of participants Interval 0.8 to 4.1	2.9 Percentage of participants Interval 1.4 to 5.2	2.3 Percentage of participants Interval 1.5 to 3.4	1.7 Percentage of participants Interval 0.4 to 5.0	1.4 Percentage of participants Interval 0.5 to 3.3
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Fever >40.0 C	0 Percentage of participants Interval 0.0 to 1.0	0 Percentage of participants Interval 0.0 to 1.0	0.3 Percentage of participants Interval 0.0 to 1.6	0.1 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 2.1	0 Percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Fatigue	78.6 Percentage of participants Interval 74.0 to 82.8	73.6 Percentage of participants Interval 68.6 to 78.1	81.0 Percentage of participants Interval 76.4 to 85.0	77.8 Percentage of participants Interval 75.1 to 80.3	76.9 Percentage of participants Interval 69.9 to 82.9	75.5 Percentage of participants Interval 70.7 to 79.9
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Headache	66.7 Percentage of participants Interval 61.5 to 71.6	65.1 Percentage of participants Interval 59.8 to 70.0	64.3 Percentage of participants Interval 59.0 to 69.3	65.4 Percentage of participants Interval 62.4 to 68.3	68.8 Percentage of participants Interval 61.3 to 75.6	63.8 Percentage of participants Interval 58.5 to 68.9
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Chills	32.8 Percentage of participants Interval 27.9 to 37.9	34.1 Percentage of participants Interval 29.1 to 39.3	37.2 Percentage of participants Interval 32.1 to 42.5	34.7 Percentage of participants Interval 31.8 to 37.7	32.4 Percentage of participants Interval 25.5 to 39.9	26.2 Percentage of participants Interval 21.7 to 31.1
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study Diarrhea	16.2 Percentage of participants Interval 12.5 to 20.5	14.2 Percentage of participants Interval 10.7 to 18.3	13.8 Percentage of participants Interval 10.4 to 17.9	14.8 Percentage of participants Interval 12.7 to 17.1	15.0 Percentage of participants Interval 10.1 to 21.2	15.4 Percentage of participants Interval 11.8 to 19.6
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study New/worsened muscle pain	38.7 Percentage of participants Interval 33.6 to 44.1	43.5 Percentage of participants Interval 38.2 to 48.8	43.2 Percentage of participants Interval 37.9 to 48.6	41.8 Percentage of participants Interval 38.8 to 44.9	43.9 Percentage of participants Interval 36.4 to 51.7	40.5 Percentage of participants Interval 35.3 to 45.8
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study New/worsened joint pain	23.4 Percentage of participants Interval 19.0 to 28.1	27.3 Percentage of participants Interval 22.7 to 32.2	23.9 Percentage of participants Interval 19.5 to 28.8	24.9 Percentage of participants Interval 22.3 to 27.6	24.3 Percentage of participants Interval 18.1 to 31.4	22.2 Percentage of participants Interval 18.0 to 26.9

PRIMARY outcome

Timeframe: Within 7 days after Dose 3

Population: Safety population included all randomized participants who received dose 3 of the study intervention.

Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 C and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 3 were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=31 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=31 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Fever >=38.0 C to 38.4 C	0 Percentage of participants Interval 0.0 to 11.2	6.5 Percentage of participants Interval 0.8 to 21.4	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Fever >38.4 C to 38.9 C	3.2 Percentage of participants Interval 0.1 to 16.7	0 Percentage of participants Interval 0.0 to 11.2	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Fatigue	67.7 Percentage of participants Interval 48.6 to 83.3	83.9 Percentage of participants Interval 66.3 to 94.5	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Vomiting	3.2 Percentage of participants Interval 0.1 to 16.7	0 Percentage of participants Interval 0.0 to 11.2	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Fever >=38.0 C	3.2 Percentage of participants Interval 0.1 to 16.7	6.5 Percentage of participants Interval 0.8 to 21.4	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Fever >38.9 C to 40.0 C	0 Percentage of participants Interval 0.0 to 11.2	0 Percentage of participants Interval 0.0 to 11.2	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Fever >40.0 C	0 Percentage of participants Interval 0.0 to 11.2	0 Percentage of participants Interval 0.0 to 11.2	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Headache	41.9 Percentage of participants Interval 24.5 to 60.9	58.1 Percentage of participants Interval 39.1 to 75.5	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Chills	25.8 Percentage of participants Interval 11.9 to 44.6	19.4 Percentage of participants Interval 7.5 to 37.5	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Diarrhea	16.1 Percentage of participants Interval 5.5 to 33.7	6.5 Percentage of participants Interval 0.8 to 21.4	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study New/worsened muscle pain	41.9 Percentage of participants Interval 24.5 to 60.9	19.4 Percentage of participants Interval 7.5 to 37.5	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study New/worsened joint pain	12.9 Percentage of participants Interval 3.6 to 29.8	12.9 Percentage of participants Interval 3.6 to 29.8	—	—	—	—
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study Use of antipyretic/analgesic medication	32.3 Percentage of participants Interval 16.7 to 51.4	35.5 Percentage of participants Interval 19.2 to 54.6	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months)

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=346 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=1049 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 Participants Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study AEs	5.4 Percentage of participants	6.0 Percentage of participants	5.2 Percentage of participants	5.5 Percentage of participants	10.4 Percentage of participants	6.8 Percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study SAEs	0 Percentage of participants	0 Percentage of participants	0.3 Percentage of participants	0.1 Percentage of participants	0.6 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days)

Population: Safety population included all randomized participants who received Dose 3 of the study intervention.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=31 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=31 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study AEs	6.5 Percentage of participants	3.2 Percentage of participants	—	—	—	—
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study SAEs	0 Percentage of participants	0 Percentage of participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (prior to Dose 1 of Primary study)

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study	20.5 Titer Interval 20.5 to 20.5	20.5 Titer Interval 20.5 to 20.5	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 2 of primary study

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study	971.4 Titer Interval 750.5 to 1257.4	749.0 Titer Interval 575.2 to 975.3	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study	263.5 Titer Interval 186.9 to 371.3	224.2 Titer Interval 176.4 to 285.1	—	—	—	—

PRIMARY outcome

Timeframe: 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study	2159.3 Titer Interval 1568.4 to 2972.8	1283.4 Titer Interval 939.4 to 1753.5	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study	2035.5 Titer Interval 1502.2 to 2758.1	943.3 Titer Interval 699.1 to 1272.7	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (prior to Dose 1 of Primary study)

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Month after Dose 2 of primary study

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Before Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study	103.0 Titer Interval 75.4 to 140.8	94.0 Titer Interval 67.5 to 130.8	—	—	—	—

PRIMARY outcome

Timeframe: 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study	1614.1 Titer Interval 1172.8 to 2221.6	1729.8 Titer Interval 1160.0 to 2579.4	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study	1358.4 Titer Interval 968.5 to 1905.1	1411.1 Titer Interval 950.1 to 2095.9	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (prior to Dose 1 of Primary study)

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study	3.4 Unit per milliliter Interval 2.0 to 5.7	3.4 Unit per milliliter Interval 2.3 to 5.1	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 2 of primary study

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study	6529.1 Unit per milliliter Interval 5212.9 to 8177.6	3796.9 Unit per milliliter Interval 1899.8 to 7588.4	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study	1834.5 Unit per milliliter Interval 1458.5 to 2307.5	1851.6 Unit per milliliter Interval 1441.9 to 2377.8	—	—	—	—

PRIMARY outcome

Timeframe: 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study	10756.9 Unit per milliliter Interval 8478.9 to 13647.0	10412.3 Unit per milliliter Interval 7733.0 to 14020.0	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study	7983.0 Unit per milliliter Interval 6266.0 to 10170.6	6676.9 Unit per milliliter Interval 5242.6 to 8503.6	—	—	—	—

PRIMARY outcome

Timeframe: From 1 Month after Dose 2 to 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study	1.6 Fold rise Interval 1.3 to 2.0	2.7 Fold rise Interval 1.3 to 5.9	—	—	—	—

PRIMARY outcome

Timeframe: From 1 Month after Dose 2 to 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study	1.2 Fold rise Interval 1.0 to 1.5	1.8 Fold rise Interval 0.9 to 3.6	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3 to 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study	5.9 Fold rise Interval 4.9 to 7.0	5.6 Fold rise Interval 4.4 to 7.2	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3 to 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study	4.4 Fold rise Interval 3.7 to 5.2	3.6 Fold rise Interval 2.9 to 4.5	—	—	—	—

PRIMARY outcome

Timeframe: From 1 Month after Dose 2 to 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study	2.2 Fold rise Interval 1.6 to 3.0	1.7 Fold rise Interval 1.3 to 2.2	—	—	—	—

PRIMARY outcome

Timeframe: From 1 Month after Dose 2 to 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study	2.1 Fold rise Interval 1.6 to 2.7	1.2 Fold rise Interval 0.9 to 1.6	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3 to 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study	8.2 Fold rise Interval 5.3 to 12.7	5.7 Fold rise Interval 4.5 to 7.3	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3 to 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study	7.7 Fold rise Interval 5.6 to 10.7	4.2 Fold rise Interval 3.2 to 5.5	—	—	—	—

PRIMARY outcome

Timeframe: From 1 Month after Dose 2 to 1 Week after Dose 3

Population: Data for this outcome was not analyzed as the immunogenicity samples from 1 month after dose 2 were not tested for SARS-CoV-2 B.1.351-strain as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From 1 Month after Dose 2 to 1 Month after Dose 3

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Before Dose 3 to 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study	15.7 Fold rise Interval 11.2 to 22.0	18.4 Fold rise Interval 13.8 to 24.6	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3 to 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=26 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study	13.2 Fold rise Interval 9.6 to 18.1	15.0 Fold rise Interval 11.3 to 19.9	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 2

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

Seroresponse was defined as greater than equal to (\>=) 4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study	100 Percentage of participants Interval 87.2 to 100.0	100 Percentage of participants Interval 86.3 to 100.0	—	—	—	—

PRIMARY outcome

Timeframe: Before Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Seroresponse to Reference Strain Before Dose 3: Booster Study	92.6 Percentage of participants Interval 75.7 to 99.1	92.0 Percentage of participants Interval 74.0 to 99.0	—	—	—	—

PRIMARY outcome

Timeframe: 1 Week after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study	100.0 Percentage of participants Interval 87.2 to 100.0	100.0 Percentage of participants Interval 86.3 to 100.0	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 3

Population: Booster evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, Dose 2 - primary study, Dose 3 - booster study within predefined window, had at least 1 valid immunogenicity result from blood sample collected within appropriate window at 1 month after Dose 3, were negative for both SARS-CoV-2 test at Dose 1,1-month post Dose 2, 3, and had no other protocol deviations determined by clinician. Here, "N" = participants evaluable for this outcome measure.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=27 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=25 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Percentage of Participants With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study	100.0 Percentage of participants Interval 87.2 to 100.0	100.0 Percentage of participants Interval 86.3 to 100.0	—	—	—	—

PRIMARY outcome

Timeframe: 1 Month after Dose 2

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at baseline and 1 month after dose 2 as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Before Dose 3

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Week after Dose 3

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Month after Dose 3

Population: Data for this outcome was not analyzed as the immunogenicity samples were not tested for SARS-CoV-2 B.1.351-strain at Baseline as the South African strain was no longer of clinical interest and required responses have been well understood from other studies.

Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (before Dose 1), 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test during study and had no other protocol deviations determined by clinician. Here, N=participants evaluable for this outcome measure and n=participants evaluable at specified time points.

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\* LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=324 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=311 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=310 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=945 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=160 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study Baseline	3.1 Unit per milliliter Interval 2.7 to 3.5	2.6 Unit per milliliter Interval 2.3 to 3.0	2.6 Unit per milliliter Interval 2.2 to 3.0	2.8 Unit per milliliter Interval 2.5 to 3.0	2.6 Unit per milliliter Interval 2.1 to 3.2	—
Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study 1 Month After Dose 2	6269.8 Unit per milliliter Interval 5717.7 to 6875.2	6222.3 Unit per milliliter Interval 5721.5 to 6766.9	6818.9 Unit per milliliter Interval 6280.9 to 7403.1	6428.7 Unit per milliliter Interval 6116.6 to 6756.8	6098.9 Unit per milliliter Interval 5446.0 to 6830.1	—

SECONDARY outcome

Timeframe: From Baseline (before Dose 1) up to 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=323 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=311 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=310 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots n=944 Participants Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=160 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study	2036.6 Fold rise Interval 1744.5 to 2377.7	2367.1 Fold rise Interval 2028.6 to 2762.2	2645.2 Fold rise Interval 2271.2 to 3080.8	2331.9 Fold rise Interval 2133.7 to 2548.5	2373.8 Fold rise Interval 1901.2 to 2963.9	—

SECONDARY outcome

Timeframe: Baseline (before Dose 1), 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\* LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=324 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=318 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Titers (GMT) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study Baseline	20.5 Titer Interval 20.5 to 20.5	20.5 Titer Interval 20.5 to 20.5	—	—	—	—
Geometric Mean Titers (GMT) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study 1 Month after Dose 2	969.6 Titer Interval 905.7 to 1038.0	913.0 Titer Interval 843.4 to 988.3	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline (before Dose 1) up to 1 Month after Dose 2

Population: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 at 1 month after Dose 2 to the geometric mean titers of SARS-CoV-2 at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\* LLOQ.

Outcome measures

Outcome measures
Measure	BNT162b2 30 mcg: US Lot 1 n=324 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=318 Participants Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	Pooled US Lots Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study	47.3 Fold rise Interval 44.2 to 50.6	44.5 Fold rise Interval 41.1 to 48.2	—	—	—	—

Adverse Events

BNT162b2 30 mcg: US Lot 1

Serious events: 0 serious events

Other events: 341 other events

Deaths: 0 deaths

BNT162b2 30 mcg: US Lot 2

Serious events: 0 serious events

Other events: 336 other events

Deaths: 0 deaths

BNT162b2 30 mcg: US Lot 3

Serious events: 1 serious events

Other events: 335 other events

Deaths: 0 deaths

BNT162b2 30 mcg: EU Lot

Serious events: 1 serious events

Other events: 165 other events

Deaths: 0 deaths

BNT162b2 20 mcg: US Lot 1

Serious events: 0 serious events

Other events: 342 other events

Deaths: 0 deaths

BNT162b2 30 mcg: Booster Dose

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

BNT162b2.B.1.351 30 mcg: Booster Dose

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BNT162b2 30 mcg: US Lot 1 n=351 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=347 participants at risk；n=346 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 participants at risk Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: Booster Dose n=31 participants at risk Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.	BNT162b2.B.1.351 30 mcg: Booster Dose n=31 participants at risk Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Nervous system disorders Migrainosus	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/346 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.58% 1/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.29% 1/346 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.

Other adverse events

Other adverse events
Measure	BNT162b2 30 mcg: US Lot 1 n=351 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 2 n=352 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: US Lot 3 n=347 participants at risk；n=346 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: EU Lot n=173 participants at risk Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 20 mcg: US Lot 1 n=351 participants at risk Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.	BNT162b2 30 mcg: Booster Dose n=31 participants at risk Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.	BNT162b2.B.1.351 30 mcg: Booster Dose n=31 participants at risk Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Gastrointestinal disorders Diarrhoea	16.2% 57/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	14.2% 50/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	13.8% 48/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	15.0% 26/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	15.4% 54/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	16.1% 5/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.5% 2/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Gastrointestinal disorders Vomiting	2.8% 10/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	2.0% 7/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.5% 12/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	2.3% 4/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	2.3% 8/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.2% 1/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
General disorders Chills	32.8% 115/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	34.1% 120/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	37.2% 129/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	32.4% 56/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	26.2% 92/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	25.8% 8/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	19.4% 6/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
General disorders Fatigue	78.6% 276/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	73.6% 259/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	81.0% 281/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	76.9% 133/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	75.5% 265/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	67.7% 21/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	83.9% 26/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
General disorders Injection site erythema	4.6% 16/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	5.4% 19/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.6% 23/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	4.6% 8/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	4.6% 16/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	9.7% 3/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.2% 1/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
General disorders Injection site pain	90.9% 319/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	85.8% 302/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	91.1% 316/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	91.3% 158/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	89.5% 314/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	90.3% 28/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	93.5% 29/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
General disorders Injection site swelling	6.0% 21/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	8.8% 31/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	7.2% 25/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	4.6% 8/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.3% 22/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.5% 2/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.5% 2/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
General disorders Pyrexia	7.4% 26/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.2% 22/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	8.4% 29/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	9.2% 16/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	5.7% 20/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.2% 1/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	6.5% 2/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Musculoskeletal and connective tissue disorders Arthralgia	23.4% 82/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	27.3% 96/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	23.9% 83/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	24.3% 42/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	22.2% 78/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	12.9% 4/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	12.9% 4/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Musculoskeletal and connective tissue disorders Myalgia	38.7% 136/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	43.5% 153/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	43.2% 150/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	43.9% 76/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	40.5% 142/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	41.9% 13/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	19.4% 6/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Nervous system disorders Headache	66.7% 234/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	65.1% 229/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	64.3% 223/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	68.8% 119/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	63.8% 224/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	41.9% 13/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	58.1% 18/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Nervous system disorders Syncope	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	1.2% 2/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign abdominal neoplasm	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.2% 1/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.2% 1/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.28% 1/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.29% 1/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	1.7% 3/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.57% 2/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/352 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/347 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/173 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/351 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	0.00% 0/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.	3.2% 1/31 • AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.

Additional Information

BioNTech clinical trials patient information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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