Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults (NCT NCT04588480)

Last Updated: 2023-02-01

Results Overview

Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

160 participants

Primary outcome timeframe

Within 7 days after Dose 1

Results posted on

2023-02-01

Participant Flow

Originally, study was blinded and participants received 2 doses of ribonucleic acid (RNA)-based COVID-19 vaccine (BNT162b2) and placebo. After protocol amendment 3, the study was unblinded and all participants who originally received placebo were offered the opportunity to receive BNT162b2 vaccine before the 6-month follow-up visit.

Participant milestones

Participant milestones
Measure	BNT162b2 Participants received 2 doses of blinded 30 microgram (mcg) BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo Then BNT162b2 Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding. Participants were followed for up to 6 months after last dose of vaccination.
Blinded Phase: Up to 6 Months STARTED	119	41	0
Blinded Phase: Up to 6 Months COMPLETED	119	41	0
Blinded Phase: Up to 6 Months NOT COMPLETED	0	0	0
Unblinded Phase: From 6 to 12 Months STARTED	119	6	35
Unblinded Phase: From 6 to 12 Months COMPLETED	117	3	35
Unblinded Phase: From 6 to 12 Months NOT COMPLETED	2	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BNT162b2 Participants received 2 doses of blinded 30 microgram (mcg) BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo Then BNT162b2 Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding. Participants were followed for up to 6 months after last dose of vaccination.
Unblinded Phase: From 6 to 12 Months Protocol Violation	0	1	0
Unblinded Phase: From 6 to 12 Months Other	2	2	0

Baseline Characteristics

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BNT162b2 n=119 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Total n=160 Participants Total of all reporting groups
Age, Continuous	46.8 Years STANDARD_DEVIATION 16.16 • n=5 Participants	44.8 Years STANDARD_DEVIATION 17.76 • n=7 Participants	46.3 Years STANDARD_DEVIATION 16.55 • n=5 Participants
Age, Customized 20-64 Years	97 Participants n=5 Participants	33 Participants n=7 Participants	130 Participants n=5 Participants
Age, Customized 65-85 Years	22 Participants n=5 Participants	8 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	19 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	22 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants	41 Participants n=7 Participants	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	119 Participants n=5 Participants	41 Participants n=7 Participants	160 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

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.

Outcome measures

Outcome measures
Measure	BNT162b2 n=119 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Redness: Mild	7.6 Percentage of participants Interval 3.5 to 13.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Redness: Moderate	5.9 Percentage of participants Interval 2.4 to 11.7	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Redness: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Redness: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Swelling: Mild	9.2 Percentage of participants Interval 4.7 to 15.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Swelling: Moderate	3.4 Percentage of participants Interval 0.9 to 8.4	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Swelling: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Pain at the injection site: Mild	57.1 Percentage of participants Interval 47.7 to 66.2	2.4 Percentage of participants Interval 0.1 to 12.9
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Pain at the injection site: Moderate	27.7 Percentage of participants Interval 19.9 to 36.7	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Pain at the injection site: Severe	1.7 Percentage of participants Interval 0.2 to 5.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 Pain at the injection site: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6

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" signifies participants evaluable for this outcome measure.

Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.

Outcome measures

Outcome measures
Measure	BNT162b2 n=116 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Redness: Mild	6.0 Percentage of participants Interval 2.5 to 12.0	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Redness: Moderate	4.3 Percentage of participants Interval 1.4 to 9.8	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Redness: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Redness: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Swelling: Mild	4.3 Percentage of participants Interval 1.4 to 9.8	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Swelling: Moderate	4.3 Percentage of participants Interval 1.4 to 9.8	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Swelling: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Pain at the injection site: Mild	50.9 Percentage of participants Interval 41.4 to 60.3	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Pain at the injection site: Moderate	26.7 Percentage of participants Interval 18.9 to 35.7	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Pain at the injection site: Severe	1.7 Percentage of participants Interval 0.2 to 6.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 Pain at the injection site: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6

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.

Systemic events were recorded by participants in e-diary. Fever was categorized as greater than or equal to (\>=)37.5 to 38.4 degrees(deg) Celsius(C), \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.

Outcome measures

Outcome measures
Measure	BNT162b2 n=119 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fever: >= 37.5 to 38.4 deg C	11.8 Percentage of participants Interval 6.6 to 19.0	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fever: >38.4 to 38.9 deg C	2.5 Percentage of participants Interval 0.5 to 7.2	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fever: >38.9 to 40.0 deg C	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fever: >40.0 deg C	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fatigue: Mild	22.7 Percentage of participants Interval 15.5 to 31.3	7.3 Percentage of participants Interval 1.5 to 19.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fatigue: Moderate	16.8 Percentage of participants Interval 10.6 to 24.8	2.4 Percentage of participants Interval 0.1 to 12.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fatigue: Severe	0.8 Percentage of participants Interval 0.0 to 4.6	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Fatigue: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Headache: Mild	21.8 Percentage of participants Interval 14.8 to 30.4	7.3 Percentage of participants Interval 1.5 to 19.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Headache: Moderate	10.1 Percentage of participants Interval 5.3 to 17.0	7.3 Percentage of participants Interval 1.5 to 19.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Headache: Severe	0.8 Percentage of participants Interval 0.0 to 4.6	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Headache: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Chills: Mild	16.0 Percentage of participants Interval 9.9 to 23.8	4.9 Percentage of participants Interval 0.6 to 16.5
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Chills: Moderate	8.4 Percentage of participants Interval 4.1 to 14.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Chills: Severe	0.8 Percentage of participants Interval 0.0 to 4.6	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Chills: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Vomiting: Mild	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Vomiting: Moderate	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Vomiting: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Diarrhea: Mild	3.4 Percentage of participants Interval 0.9 to 8.4	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Diarrhea: Moderate	1.7 Percentage of participants Interval 0.2 to 5.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 Diarrhea: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened muscle pain: Mild	10.1 Percentage of participants Interval 5.3 to 17.0	2.4 Percentage of participants Interval 0.1 to 12.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened muscle pain: Moderate	4.2 Percentage of participants Interval 1.4 to 9.5	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened muscle pain: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened muscle pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened joint pain: Mild	9.2 Percentage of participants Interval 4.7 to 15.9	4.9 Percentage of participants Interval 0.6 to 16.5
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened joint pain: Moderate	4.2 Percentage of participants Interval 1.4 to 9.5	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened joint pain: Severe	0.8 Percentage of participants Interval 0.0 to 4.6	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 New or worsened joint pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6

PRIMARY outcome

Timeframe: Within 7 days after Dose 2

Systemic events were recorded by participants in an e-diary. Fever was categorized as \>= 37.5 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.

Outcome measures

Outcome measures
Measure	BNT162b2 n=116 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fever: >= 37.5 to 38.4 deg C	25.0 Percentage of participants Interval 17.4 to 33.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fever: >38.4 to 38.9 deg C	6.9 Percentage of participants Interval 3.0 to 13.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fever: >38.9 to 40.0 deg C	0.9 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fever: >40.0 deg C	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fatigue: Mild	25.9 Percentage of participants Interval 18.2 to 34.8	2.4 Percentage of participants Interval 0.1 to 12.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fatigue: Moderate	31.0 Percentage of participants Interval 22.8 to 40.3	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fatigue: Severe	3.4 Percentage of participants Interval 0.9 to 8.6	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Fatigue: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Headache: Mild	25.0 Percentage of participants Interval 17.4 to 33.9	7.3 Percentage of participants Interval 1.5 to 19.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Headache: Moderate	17.2 Percentage of participants Interval 10.9 to 25.4	4.9 Percentage of participants Interval 0.6 to 16.5
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Headache: Severe	1.7 Percentage of participants Interval 0.2 to 6.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Headache: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Chills: Mild	24.1 Percentage of participants Interval 16.7 to 33.0	2.4 Percentage of participants Interval 0.1 to 12.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Chills: Moderate	19.8 Percentage of participants Interval 13.0 to 28.3	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Chills: Severe	1.7 Percentage of participants Interval 0.2 to 6.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Chills: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Vomiting: Mild	0.9 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Vomiting: Moderate	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Vomiting: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Diarrhea: Mild	5.2 Percentage of participants Interval 1.9 to 10.9	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Diarrhea: Moderate	0.0 Percentage of participants Interval 0.0 to 3.1	2.4 Percentage of participants Interval 0.1 to 12.9
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 Diarrhea: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened muscle pain: Mild	9.5 Percentage of participants Interval 4.8 to 16.3	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened muscle pain: Moderate	6.9 Percentage of participants Interval 3.0 to 13.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened muscle pain: Severe	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened muscle pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened joint pain: Mild	12.9 Percentage of participants Interval 7.4 to 20.4	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened joint pain: Moderate	11.2 Percentage of participants Interval 6.1 to 18.4	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened joint pain: Severe	0.9 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 8.6
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 New or worsened joint pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 3.1	0.0 Percentage of participants Interval 0.0 to 8.6

PRIMARY outcome

Timeframe: Dose 1 up to 1 month after Dose 2

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 temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 95% confidence interval (CI) based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	BNT162b2 n=119 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Adverse Events (AEs) From Dose 1 up to 1 Month After Dose 2	10.9 Percentage of participants Interval 5.9 to 18.0	7.3 Percentage of participants Interval 1.5 to 19.9

PRIMARY outcome

Timeframe: Dose 1 up to 12 months after Dose 2

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

SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered an important medical event. Percentage of participants with SAEs and the associated 95% CI based on the Clopper and Pearson method was presented.

Outcome measures

Outcome measures
Measure	BNT162b2 n=119 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 up to 12 Months After Dose 2	1.7 Percentage of participants Interval 0.2 to 5.9	0 Percentage of participants Interval 0.0 to 8.6

PRIMARY outcome

Timeframe: Within 1 day after Dose 1

The pre-defined criteria for laboratory parameters included: hemoglobin (HGB), hematocrit, erythrocytes(ery.) less than (\<)0.8\* lower limit of normal (LLN); ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration \<0.9\*LLN and \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN and \>1.75\*ULN; leukocytes \<0.6\*LLN and \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN and \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; bilirubin \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN; urea nitrogen, creatinine \>1.3\*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 n=9 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=3 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category 20-64 Years: Monocytes	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category 65-85 Years: Lymphocytes	22.2 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category 65-85 Years: Monocytes	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category 65-85 Years: Creatinine	11.1 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Within 7 days after Dose 1

The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. \<0.8\* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration \<0.9\*LLN and \>1.1\*ULN; platelets \<0.5\*LLN and \>1.75\*ULN; leukocytes \<0.6\*LLN and \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN and \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; bilirubin \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN; urea nitrogen, creatinine \>1.3\*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.

Outcome measures

Outcome measures
Measure	BNT162b2 n=9 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=3 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 1 by Age Category 65-85 Years: Lymphocytes	0.0 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 1 by Age Category 20-64 Years: Eosinophils	11.1 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Within 7 days after Dose 2

The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. \<0.8\* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration \<0.9\*LLN and \>1.1\*ULN; platelets \<0.5\*LLN and \>1.75\*ULN; leukocytes \<0.6\*LLN and \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN and \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; bilirubin \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN; urea nitrogen, creatinine \>1.3\*ULN. Categories with at least 1 non-zero data value were reported (only 65-85 years: Lymphocytes category was reported).

Outcome measures

Outcome measures
Measure	BNT162b2 n=9 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=3 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 2 by Age Category	22.2 Percentage of participants	33.3 Percentage of participants

PRIMARY outcome

Timeframe: From baseline (observation prior to Dose 1) up to 1 day after Dose 1

Hematology parameters: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, white blood cell (WBC) decrease, WBC increase. Chemistry parameters: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, blood urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	BNT162b2 n=9 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=3 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 20-64 Years- Lymphocytes: Normal (at baseline) to Grade 1 (at post baseline)	22.2 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 20-64 Years- Neutrophil Decrease: Normal (at baseline) to Grade 1 (at post baseline)	55.6 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 20-64 Years- WBC Decrease: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- Alanine Aminotransferase Increased: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years-Aspartate Aminotransferase Increased: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- Hemoglobin: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- Lymphocytes: Normal (at baseline) to Grade 1 (at post baseline)	33.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- Neutrophil Decrease: Normal (at baseline) to Grade 1 (at post baseline)	22.2 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- Neutrophil Decrease: Normal (at baseline) to Grade 2 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- Urea Nitrogen: Normal (at baseline) to Grade 1 (at post baseline)	0.0 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category 65-85 Years- WBC Decrease: Normal (at baseline) to Grade 1 (at post baseline)	33.3 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: From baseline (observation prior to Dose 1) up to 7 days after Dose 1

Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from baseline to 7 days after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	BNT162b2 n=9 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=3 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 20-64 Years- Hemoglobin: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 20-64 Years- Neutrophil Decrease: Grade 1 (at baseline) to Normal (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 65-85 Years- Alanine Aminotransferase Increased: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 65-85 Years-Aspartate Aminotransferase Increased: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 65-85 Years- Hemoglobin: Normal (at baseline) to Grade 1 (at post baseline)	11.1 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 65-85 Years- Hemoglobin: Grade 1 (at baseline) to Grade 2 (at post baseline)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 65-85 Years- Lymphocytes: Normal (at baseline) to Grade 1 (at post baseline)	0.0 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category 65-85 Years- WBC Decrease: Normal (at baseline) to Grade 1 (at post baseline)	0.0 Percentage of participants	33.3 Percentage of participants

PRIMARY outcome

Timeframe: Before Dose 2 up to 7 days after Dose 2

Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3= severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from before dose 2 to 7 days after dose 2 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	BNT162b2 n=9 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=3 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 20-64 Years- Alanine Aminotransferase Increased: Grade 1 (before dose 2) to Normal (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 20-64 Years- Eosinophils: Grade 1 (before dose 2) to Normal (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 20-64 Years- Hemoglobin: Normal (before dose 2) to Grade 1 (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 20-64 Years- Hemoglobin: Grade 1 (before dose 2) to Normal (post dose 2)	11.1 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 20-64 Years- Neutrophil Decrease: Grade 1 (before dose 2) to Normal (post dose 2)	22.2 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 20-64 Years- WBC Decrease: Grade 1 (before dose 2) to Normal (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years-Aspartate Aminotransferase Increased: Normal (before dose 2) to Grade 1 (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- Bilirubin: Grade 1 (before dose 2) to Normal (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- Hemoglobin: Normal (before dose 2) to Grade 1 (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- Hemoglobin: Grade 1 (before dose 2) to Grade 2 (post dose 2)	11.1 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- Lymphocytes: Normal (before dose 2) to Grade 1 (post dose 2)	0.0 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- Neutrophil Decrease: Normal (before dose 2) to Grade 1 (post dose 2)	22.2 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- Urea Nitrogen: Normal (before dose 2) to Grade 1 (post dose 2)	0.0 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category 65-85 Years- WBC Decrease: Normal (before dose 2) to Grade 1 (post dose 2)	11.1 Percentage of participants	33.3 Percentage of participants

PRIMARY outcome

Timeframe: 1 month after Dose 2

Population: Evaluable immunogenicity population (EIP): all randomized participants who received 2 doses of the assigned vaccine, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), had at least 1 valid and determinate immunogenicity result from the blood collection within an appropriate window after Dose 2 (within 28-42 days after Dose 2) and had no other major protocol deviations as determined by clinician.

GMT of SARS-CoV-2 neutralizing titer was calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student's t distribution. GMT of SARS-CoV-2 neutralization titer 50% (NT50) was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	BNT162b2 n=116 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 2	524.5 Titer Interval 459.7 to 598.4	10.6 Titer Interval 9.8 to 11.4

PRIMARY outcome

Timeframe: Before vaccination up to 1 month after Dose 2

Population: EIP: all randomized participants who received 2 doses of the assigned vaccine, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), had at least 1 valid and determinate immunogenicity result from the blood collection within an appropriate window after Dose 2 (within 28-42 days after Dose 2) and had no other major protocol deviations as determined by clinician.

GMFR was defined as the result after vaccination divided by the result before vaccination. GMFR and the corresponding 2-sided 95% CIs was calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFR of SARS-CoV-2 NT50 was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	BNT162b2 n=116 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
Geometric Mean Fold Rises (GMFRs) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After Dose 2	51.5 Fold rise Interval 45.2 to 58.7	1.1 Fold rise Interval 1.0 to 1.1

SECONDARY outcome

Timeframe: NT50: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days after Dose 2

GMTs of SARS-CoV-2 neutralizing titers were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student's t distribution. GMTs of SARS-CoV-2 NT50 and neutralization titer 90% (NT90) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	BNT162b2 n=116 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: Baseline	10.2 Titer Interval 9.8 to 10.6	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: 21 days after Dose 1	29.2 Titer Interval 24.3 to 35.2	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: 7 days after Dose 2	408.2 Titer Interval 352.0 to 473.3	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: 14 days after Dose 2	379.4 Titer Interval 335.3 to 429.3	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: 6 months after Dose 2	145.6 Titer Interval 126.1 to 168.2	20.5 Titer Interval 20.5 to 20.5
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: 12 months after Dose 2	74.2 Titer Interval 59.6 to 92.3	63.8 Titer Interval 0.5 to 8440.7
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: Baseline	10.1 Titer Interval 9.9 to 10.2	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: 21 days after Dose 1	11.4 Titer Interval 10.5 to 12.5	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: 7 days after Dose 2	104.3 Titer Interval 90.1 to 120.7	10.0 Titer Interval 10.0 to 10.0
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: 14 days after Dose 2	95.8 Titer Interval 84.8 to 108.2	10.0 Titer Interval 10.0 to 10.0

SECONDARY outcome

Timeframe: NT50: Before vaccination up to 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2

GMFR was defined as the result after vaccination divided by the result before vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFRs of SARS-CoV-2 NT50 and NT90 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	BNT162b2 n=116 Participants Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 Participants Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: before vaccination up to 21 days after Dose 1	2.9 Fold rise Interval 2.4 to 3.4	1.0 Fold rise Interval 1.0 to 1.0
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: before vaccination up to 7 days after Dose 2	40.1 Fold rise Interval 34.6 to 46.5	1.0 Fold rise Interval 1.0 to 1.0
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: before vaccination up to 14 days after Dose 2	37.2 Fold rise Interval 32.9 to 42.1	1.0 Fold rise Interval 1.0 to 1.0
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: before vaccination up to 6 months after Dose 2	14.3 Fold rise Interval 12.4 to 16.5	2.1 Fold rise Interval 2.1 to 2.1
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT50: before vaccination up to 12 months after Dose 2	7.3 Fold rise Interval 5.9 to 9.1	6.4 Fold rise Interval 0.0 to 844.1
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: before vaccination up to 21 days after Dose 1	1.1 Fold rise Interval 1.1 to 1.2	1.0 Fold rise Interval 1.0 to 1.0
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: before vaccination up to 7 days after Dose 2	10.3 Fold rise Interval 8.9 to 12.0	1.0 Fold rise Interval 1.0 to 1.0
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 NT90: before vaccination up to 14 days after Dose 2	9.5 Fold rise Interval 8.4 to 10.7	1.0 Fold rise Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 1, 6 and 12 months after Dose 2

Population: Data was not analyzed as there were no participants with or without confirmed COVID-19 before Dose 2 prior to unblinding.

GMTs of SARS-CoV-2 neutralizing titers was planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student's t distribution.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2 and 1, 6 and 12 months after Dose 2

Population: Data was not analyzed as there were no participants with or without confirmed COVID-19 before Dose 2 prior to unblinding.

GMFR was defined as the result after vaccination divided by the result before vaccination. GMFRs and the corresponding 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution).

Outcome measures

Outcome data not reported

Adverse Events

BNT162b2

Serious events: 2 serious events

Other events: 111 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo Then BNT162b2

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BNT162b2 n=119 participants at risk Participants received 2 doses of blinded 30 mcg BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo n=41 participants at risk Participants received 2 doses of placebo (normal sterile saline solution) as an intramuscular injection separated by 21 days. Participants were followed up to 12 months after last dose of vaccination.	Placebo Then BNT162b2 n=35 participants at risk Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding. Participants were followed for up to 6 months after last dose of vaccination.
Infections and infestations Pneumonia	0.84% 1/119 • Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm. Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.	0.00% 0/41 • Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm. Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.	0.00% 0/35 • Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm. Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.84% 1/119 • Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm. Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.	0.00% 0/41 • Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm. Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.	0.00% 0/35 • Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm. Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.

Other adverse events

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