Trial Outcomes & Findings for Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects (NCT NCT04523571)

Last Updated: 2023-09-18

Results Overview

Solicited local AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by United States (US) Food and Drug Administration (FDA) criteria along with the 14-day period AE assessment as graded by National Medical Products Administration (NMPA) criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. All the solicited local AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

144 participants

Primary outcome timeframe

Up to 14 days following each dose administration

Results posted on

2023-09-18

Participant Flow

A total of 144 subjects were randomized in this phase I clinical trial, including 72 adult subjects aged 18-55 years old (including boundary value) and 72 elderly subjects aged 65-85 years old (including boundary value). The subjects received either BNT162b1 10 µg (low dose), BNT162b1 30 µg (high dose), or placebo on Day 1 and Day 22, respectively.

All enrolled participants were allocated to treatment.

Participant milestones

Participant milestones
Measure	Low-dose 10 µg, 18-55 Years of Age BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age Placebo: Intramuscular injection
Received 2 Doses STARTED	24	24	24	24	24	24
Received 2 Doses COMPLETED	24	24	24	23	23	24
Received 2 Doses NOT COMPLETED	0	0	0	1	1	0
Received 2 Doses and Completed Follow-up STARTED	24	24	24	23	23	24
Received 2 Doses and Completed Follow-up COMPLETED	23	24	23	22	22	23
Received 2 Doses and Completed Follow-up NOT COMPLETED	1	0	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Low-dose 10 µg, 18-55 Years of Age BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age Placebo: Intramuscular injection
Received 2 Doses Withdrawal by Subject	0	0	1	1	0
Received 2 Doses and Completed Follow-up inoculated with other COVID-19 vaccine	1	1	0	0	0
Received 2 Doses and Completed Follow-up Withdrawal by Subject	0	0	0	0	1
Received 2 Doses and Completed Follow-up Adverse Event	0	0	1	1	0

Baseline Characteristics

Totals are presented by age group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=144 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	72 Participants n=144 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	72 Participants n=144 Participants
Age, Continuous Group, 18-55 years of age	38 years STANDARD_DEVIATION 9.6 • n=24 Participants • Totals are presented by age group.	40 years STANDARD_DEVIATION 9.0 • n=24 Participants • Totals are presented by age group.	42 years STANDARD_DEVIATION 8.7 • n=24 Participants • Totals are presented by age group.	—	—	—	40 years STANDARD_DEVIATION 9.2 • n=72 Participants • Totals are presented by age group.
Age, Continuous Group, 65-85 years of age	—	—	—	71 years STANDARD_DEVIATION 5.0 • n=24 Participants • Totals are presented by age group.	69 years STANDARD_DEVIATION 3.0 • n=24 Participants • Totals are presented by age group.	71 years STANDARD_DEVIATION 4.4 • n=24 Participants • Totals are presented by age group.	70 years STANDARD_DEVIATION 4.2 • n=72 Participants • Totals are presented by age group.
Sex: Female, Male Female	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	72 Participants n=144 Participants
Sex: Female, Male Male	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	12 Participants n=24 Participants	72 Participants n=144 Participants
Race/Ethnicity, Customized Asian	24 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	144 Participants n=144 Participants
Region of Enrollment China	24 participants n=24 Participants	24 participants n=24 Participants	24 participants n=24 Participants	24 participants n=24 Participants	24 participants n=24 Participants	24 participants n=24 Participants	144 participants n=144 Participants
Weight Group 18-55 years of age	69.5 kg STANDARD_DEVIATION 12.05 • n=24 Participants • Totals are presented by age group.	62.8 kg STANDARD_DEVIATION 10.75 • n=24 Participants • Totals are presented by age group.	65.7 kg STANDARD_DEVIATION 13.26 • n=24 Participants • Totals are presented by age group.	—	—	—	66.0 kg STANDARD_DEVIATION 12.21 • n=72 Participants • Totals are presented by age group.
Weight Group 65-85 years of age	—	—	—	61.8 kg STANDARD_DEVIATION 9.83 • n=24 Participants • Totals are presented by age group.	63.8 kg STANDARD_DEVIATION 8.81 • n=24 Participants • Totals are presented by age group.	59.0 kg STANDARD_DEVIATION 8.36 • n=24 Participants • Totals are presented by age group.	61.5 kg STANDARD_DEVIATION 9.11 • n=72 Participants • Totals are presented by age group.
Body mass index (BMI) Group 18-55 years of age	24.7 kg/m^2 STANDARD_DEVIATION 3.18 • n=24 Participants • Totals are presented by age group.	23.0 kg/m^2 STANDARD_DEVIATION 2.71 • n=24 Participants • Totals are presented by age group.	24.3 kg/m^2 STANDARD_DEVIATION 3.43 • n=24 Participants • Totals are presented by age group.	—	—	—	24.0 kg/m^2 STANDARD_DEVIATION 3.16 • n=72 Participants • Totals are presented by age group.
Body mass index (BMI) Group 65-85 years of age	—	—	—	23.9 kg/m^2 STANDARD_DEVIATION 2.95 • n=24 Participants • Totals are presented by age group.	24.8 kg/m^2 STANDARD_DEVIATION 2.85 • n=24 Participants • Totals are presented by age group.	23.5 kg/m^2 STANDARD_DEVIATION 2.45 • n=24 Participants • Totals are presented by age group.	24.1 kg/m^2 STANDARD_DEVIATION 2.77 • n=72 Participants • Totals are presented by age group.

PRIMARY outcome

Timeframe: Up to 14 days following each dose administration

Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 days after dose 1: Number of participants with solicited local AEs	19 Participants	24 Participants	1 Participants	13 Participants	19 Participants	0 Participants
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 days after dose 2: Number of participants with solicited local AEs	17 Participants	20 Participants	1 Participants	15 Participants	15 Participants	0 Participants
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 14 days following each dose administration

Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

Solicited systemic AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by US FDA criteria along with the 14-day period AE assessment as graded by NMPA criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. Except for 1 event (myalgia) occurred in 10 µg group and 1 event (diarrhea) occurred in placebo group, all the solicited systemic AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). All the solicited systemic AEs occurred within 14 days after vaccination were related to investigational vaccine (or placebo), except for 1 event (myalgia) occurred in placebo group and 2 events (both diarrhea; 1 event occurred in 30 µg group, 1 event occurred in placebo group).

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs	9 Participants	16 Participants	3 Participants	3 Participants	15 Participants	2 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 d after dose 2: Number of participants with solicited systemic AEs	15 Participants	21 Participants	3 Participants	7 Participants	17 Participants	1 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 14 d after dose 1: Number of participants with solicited systemic AEs	10 Participants	16 Participants	3 Participants	3 Participants	15 Participants	2 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 14 d after dose 2: Number of participants with solicited systemic AEs	15 Participants	21 Participants	3 Participants	7 Participants	17 Participants	2 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA)	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA)	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA)	0 Participants	5 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA)	3 Participants	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 21-day period after dose 1 vaccination

Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

AEs occurred during the 21-day period after dose 1 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo.	7 participants	7 participants	1 participants	2 participants	5 participants	2 participants

PRIMARY outcome

Timeframe: 28-day period after dose 2 vaccination

Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

AEs occurred during the 28-day period after dose 2 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo.	5 participants	8 participants	0 participants	2 participants	7 participants	0 participants

SECONDARY outcome

Timeframe: From Dose 1 up to Month 12

Population: Safety Analysis Set including all randomized subjects who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)	0 participants	1 participants	1 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Dose 1 up to Month 12

Population: Safety Analysis Set including all randomized subjects who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

"Related" implies the relationship between AE and vaccine is one of "Possibly related", "Probably related" and "Definitely related".

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
The Number of Participants Experiencing Related TEAEs Number of Participants with related TEAEs after dose 1	22 participants	24 participants	4 participants	16 participants	21 participants	4 participants
The Number of Participants Experiencing Related TEAEs Number of Participants with related TEAEs after dose 2	20 participants	22 participants	4 participants	18 participants	21 participants	0 participants

SECONDARY outcome

Timeframe: Hour 24 and Day 7 after dose 1 and Day 7 after dose 2

Population: The safety analysis set included all randomized subjects who receive at least one dose of the investigational vaccine/placebo and have at least one safety evaluation.

Results for CS results are displayed by abnormal parameter. Abnormal test results assessed not clinical significant are not presented. Participants with more than one 'CS' parameter are counted for each parameter separately and therefore included multiple times.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - glucose - 24 hours after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - glucose - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - glucose - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - ketone - 24 hours after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - ketone - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - ketone - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - blood - 24 hours after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - blood - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal urine routine test results - blood - Day 7 after dose 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - hematocrit - 24 hours after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - hematocrit - Day 7 after dose 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - hematocrit - Day 7 after dose 2	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1	3 Participants	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - platelet count - 24 hours after dose 1	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - platelet count - Day 7 after dose 1	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis CS abnormal hematology parameter - platelet count - Day 7 after dose 2	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months following first dose

Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.

At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody 7 days after dose 1	53.320 titer Interval 46.68 to 60.905	59.220 titer Interval 41.728 to 84.046	52.841 titer Interval 47.132 to 59.242	—	—	—
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody 21 days after dose 1	4193.710 titer Interval 2664.05 to 6601.681	4531.416 titer Interval 3029.13 to 6778.757	52.594 titer Interval 47.369 to 58.395	859.646 titer Interval 467.549 to 1580.564	2872.861 titer Interval 1685.729 to 4896.002	62.239 titer Interval 47.583 to 81.41
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody 7 days after dose 2	26548.853 titer Interval 18381.541 to 38345.078	41530.498 titer Interval 33984.171 to 50752.518	52.578 titer Interval 47.384 to 58.341	5271.560 titer Interval 2484.575 to 11184.748	23447.197 titer Interval 15268.301 to 36007.348	62.658 titer Interval 47.633 to 82.423
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody 21 days after dose 2	46810.469 titer Interval 41673.251 to 52580.97	49773.381 titer Interval 46947.113 to 52769.794	50.000 titer Interval 50.0 to 50.0	40942.862 titer Interval 33177.42 to 50525.869	44159.581 titer Interval 37139.275 to 52506.91	61.008 titer Interval 45.725 to 81.399
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody Month 3 after dose 1	27143.015 titer Interval 21023.44 to 35043.897	31584.450 titer Interval 26378.938 to 37817.196	50.000 titer Interval 50.0 to 50.0	—	—	—
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody Month 6 after dose 1	4169.448 titer Interval 2978.898 to 5835.815	5693.082 titer Interval 4412.125 to 7345.934	55.088 titer Interval 47.853 to 63.417	2223.699 titer Interval 1565.907 to 3157.811	4970.376 titer Interval 3625.506 to 6814.121	60.931 titer Interval 45.837 to 80.995
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody Month 12 after dose 1	2002.152 titer Interval 1389.905 to 2884.09	2792.605 titer Interval 2118.269 to 3681.61	50.000 titer Interval 50.0 to 50.0	1104.860 titer Interval 698.932 to 1746.542	2847.010 titer Interval 1887.353 to 4294.621	53.105 titer Interval 46.867 to 60.174

SECONDARY outcome

Timeframe: Up to 12 months following first dose

At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody 7 days after dose 1	50.000 titer Interval 50.0 to 50.0	52.903 titer Interval 47.074 to 59.453	56.644 titer Interval 48.999 to 65.482	—	—	—
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody 21 days after dose 1	13095.167 titer Interval 8395.009 to 20426.827	13046.378 titer Interval 8950.882 to 19015.777	56.699 titer Interval 49.052 to 65.537	3040.808 titer Interval 1569.768 to 5890.369	10370.854 titer Interval 5955.358 to 18060.142	74.476 titer Interval 55.679 to 99.618
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody 7 days after dose 2	38314.550 titer Interval 30173.509 to 48652.107	47324.691 titer Interval 43213.653 to 51826.824	57.377 titer Interval 49.028 to 67.146	10748.566 titer Interval 5512.317 to 20958.821	38256.083 titer Interval 30078.753 to 48656.534	75.817 titer Interval 55.962 to 102.715
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody 21 days after dose 2	49710.291 titer Interval 46764.743 to 52841.369	51200.000 titer Interval 51200.0 to 51200.0	60.605 titer Interval 48.454 to 75.804	46980.825 titer Interval 42021.855 to 52525.0	50977.162 titer Interval 50528.938 to 51429.363	65.756 titer Interval 53.237 to 81.218
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Month 3 after dose 1	40236.195 titer Interval 32999.573 to 49059.768	43050.715 titer Interval 38767.819 to 47806.766	60.439 titer Interval 49.911 to 73.188	—	—	—
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Month 6 after dose 1	8249.604 titer Interval 6186.091 to 11001.449	9608.488 titer Interval 7410.049 to 12459.167	61.768 titer Interval 50.272 to 75.894	4114.353 titer Interval 2716.614 to 6231.25	7187.827 titer Interval 5138.636 to 10054.194	54.780 titer Interval 48.06 to 62.439
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Month 12 after dose 1	2324.072 titer Interval 1677.862 to 3219.163	2804.882 titer Interval 2191.409 to 3590.094	56.083 titer Interval 47.501 to 66.216	1536.143 titer Interval 921.738 to 2560.094	2768.366 titer Interval 1880.754 to 4074.881	63.175 titer Interval 50.876 to 78.447

SECONDARY outcome

Timeframe: Up to 12 months following first dose

At Day 7, Day 21 after first dose, at Day 7, Day 21 after second dose, and at Month 3, 6, and 12 after first dose.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) 7 days after dose 1	5.000 titer Interval 5.0 to 5.0	5.000 titer Interval 5.0 to 5.0	5.000 titer Interval 5.0 to 5.0	—	—	—
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) 21 days after dose 1	18.877 titer Interval 10.586 to 33.664	14.557 titer Interval 9.712 to 21.817	5.000 titer Interval 5.0 to 5.0	6.965 titer Interval 5.037 to 9.633	10.946 titer Interval 7.213 to 16.612	5.000 titer Interval 5.0 to 5.0
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) 7 days after dose 2	56.569 titer Interval 31.503 to 101.579	119.865 titer Interval 81.547 to 176.187	5.000 titer Interval 5.0 to 5.0	14.357 titer Interval 8.689 to 23.721	49.394 titer Interval 26.334 to 92.647	5.000 titer Interval 5.0 to 5.0
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) 21 days after dose 2	232.905 titer Interval 151.299 to 358.525	253.984 titer Interval 184.601 to 349.445	5.000 titer Interval 5.0 to 5.0	80.000 titer Interval 49.173 to 130.153	160.000 titer Interval 96.736 to 264.637	5.000 titer Interval 5.0 to 5.0
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) Month 3 after dose 1	54.958 titer Interval 38.115 to 79.245	87.241 titer Interval 64.445 to 118.099	5.000 titer Interval 5.0 to 5.0	—	—	—
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) Month 6 after dose 1	16.339 titer Interval 11.274 to 23.679	27.479 titer Interval 20.383 to 37.046	5.000 titer Interval 5.0 to 5.0	10.000 titer Interval 7.219 to 13.852	20.612 titer Interval 13.303 to 31.937	5.000 titer Interval 5.0 to 5.0
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) Month 12 after dose 1	7.858 titer Interval 6.027 to 10.244	11.892 titer Interval 8.903 to 15.885	5.000 titer Interval 5.0 to 5.0	6.040 titer Interval 4.976 to 7.333	12.081 titer Interval 8.154 to 17.899	5.000 titer Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: Up to 12 months following the first dose

At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline 7 days after dose 1	0.960 fold rise Interval 0.899 to 1.025	0.998 fold rise Interval 0.993 to 1.002	0.992 fold rise Interval 0.976 to 1.008	—	—	—
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline 21 days after dose 1	75.535 fold rise Interval 45.607 to 125.103	76.351 fold rise Interval 48.641 to 119.845	0.988 fold rise Interval 0.962 to 1.013	16.501 fold rise Interval 8.998 to 30.26	52.377 fold rise Interval 30.969 to 88.586	0.997 fold rise Interval 0.991 to 1.002
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline 7 days after dose 2	478.186 fold rise Interval 316.204 to 723.147	699.755 fold rise Interval 473.456 to 1034.219	0.987 fold rise Interval 0.961 to 1.014	101.189 fold rise Interval 47.897 to 213.776	427.484 fold rise Interval 281.104 to 650.09	1.003 fold rise Interval 0.998 to 1.008
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline 21 days after dose 2	843.129 fold rise Interval 696.113 to 1021.194	838.640 fold rise Interval 586.916 to 1198.328	0.939 fold rise Interval 0.824 to 1.07	785.911 fold rise Interval 631.437 to 978.175	805.108 fold rise Interval 655.534 to 988.81	0.977 fold rise Interval 0.896 to 1.065
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline Month 3 after dose 1	488.888 fold rise Interval 359.289 to 665.234	532.172 fold rise Interval 371.322 to 762.699	0.939 fold rise Interval 0.824 to 1.07	—	—	—
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline Month 6 after dose 1	75.098 fold rise Interval 50.105 to 112.558	95.924 fold rise Interval 66.863 to 137.614	1.028 fold rise Interval 0.939 to 1.126	42.685 fold rise Interval 29.5 to 61.762	90.619 fold rise Interval 64.457 to 127.399	0.966 fold rise Interval 0.886 to 1.054
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline Month 12 after dose 1	35.898 fold rise Interval 23.326 to 55.246	47.053 fold rise Interval 33.587 to 65.918	0.936 fold rise Interval 0.817 to 1.073	21.169 fold rise Interval 13.164 to 34.039	51.688 fold rise Interval 34.959 to 76.423	0.842 fold rise Interval 0.664 to 1.069

SECONDARY outcome

Timeframe: Up to 12 months following first dose

At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline 7 days after dose 1	1.000 fold rise Interval 1.0 to 1.0	1.001 fold rise Interval 0.998 to 1.005	0.985 fold rise Interval 0.968 to 1.003	—	—	—
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline 21 days after dose 1	261.903 fold rise Interval 167.9 to 408.537	246.976 fold rise Interval 172.957 to 352.672	0.986 fold rise Interval 0.964 to 1.009	51.597 fold rise Interval 28.409 to 93.71	150.858 fold rise Interval 74.5 to 305.479	1.001 fold rise Interval 0.985 to 1.018
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline 7 days after dose 2	766.291 fold rise Interval 603.47 to 973.042	895.886 fold rise Interval 778.927 to 1030.407	0.998 fold rise Interval 0.973 to 1.023	182.382 fold rise Interval 96.77 to 343.735	556.487 fold rise Interval 351.897 to 880.024	1.020 fold rise Interval 0.981 to 1.059
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline 21 days after dose 2	994.206 fold rise Interval 935.295 to 1056.827	969.249 fold rise Interval 865.101 to 1085.934	1.054 fold rise Interval 0.99 to 1.122	797.173 fold rise Interval 645.312 to 984.773	741.532 fold rise Interval 498.207 to 1103.699	0.884 fold rise Interval 0.753 to 1.038
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline Month 3 after dose 1	804.724 fold rise Interval 659.991 to 981.195	814.977 fold rise Interval 706.611 to 939.963	1.051 fold rise Interval 0.97 to 1.14	—	—	—
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline Month 6 after dose 1	164.992 fold rise Interval 123.722 to 220.029	181.895 fold rise Interval 145.883 to 226.796	1.061 fold rise Interval 0.889 to 1.267	69.813 fold rise Interval 47.788 to 101.988	104.557 fold rise Interval 65.75 to 166.268	0.764 fold rise Interval 0.615 to 0.95
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline Month 12 after dose 1	46.481 fold rise Interval 33.557 to 64.383	53.098 fold rise Interval 42.807 to 65.863	0.970 fold rise Interval 0.893 to 1.053	25.871 fold rise Interval 16.436 to 40.724	41.548 fold rise Interval 25.869 to 66.729	0.835 fold rise Interval 0.69 to 1.01

SECONDARY outcome

Timeframe: Up to 12 months following first dose

At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. 21 days after dose 2	46.581 fold rise Interval 30.26 to 71.705	50.797 fold rise Interval 36.92 to 69.889	1.000 fold rise Interval 1.0 to 1.0	16.000 fold rise Interval 9.835 to 26.031	32.000 fold rise Interval 19.347 to 52.927	1.000 fold rise Interval 1.0 to 1.0
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. Month 6 after dose 1	3.268 fold rise Interval 2.255 to 4.736	5.496 fold rise Interval 4.077 to 7.409	1.000 fold rise Interval 1.0 to 1.0	2.000 fold rise Interval 1.444 to 2.77	4.122 fold rise Interval 2.661 to 6.387	1.000 fold rise Interval 1.0 to 1.0
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. Month 12 after dose 1	1.572 fold rise Interval 1.205 to 2.049	2.378 fold rise Interval 1.781 to 3.177	1.000 fold rise Interval 1.0 to 1.0	1.208 fold rise Interval 0.995 to 1.467	2.416 fold rise Interval 1.631 to 3.58	1.000 fold rise Interval 1.0 to 1.0
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. 7 days after dose 1	1.000 fold rise Interval 1.0 to 1.0	1.000 fold rise Interval 1.0 to 1.0	1.000 fold rise Interval 1.0 to 1.0	—	—	—
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. 21 days after dose 1	3.775 fold rise Interval 2.117 to 6.733	2.911 fold rise Interval 1.942 to 4.363	1.000 fold rise Interval 1.0 to 1.0	1.393 fold rise Interval 1.007 to 1.927	2.189 fold rise Interval 1.443 to 3.322	1.000 fold rise Interval 1.0 to 1.0
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. 7 days after dose 2	11.314 fold rise Interval 6.301 to 20.316	23.973 fold rise Interval 16.309 to 35.237	1.000 fold rise Interval 1.0 to 1.0	2.871 fold rise Interval 1.738 to 4.744	9.879 fold rise Interval 5.267 to 18.529	1.000 fold rise Interval 1.0 to 1.0
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. Month 3 after dose 1	10.992 fold rise Interval 7.623 to 15.849	17.448 fold rise Interval 12.889 to 23.62	1.000 fold rise Interval 1.0 to 1.0	—	—	—

SECONDARY outcome

Timeframe: Up to 21 days after dose 2

At Day 7, Day 21 after dose 1, and at Day 7, Day 21 after dose 2.

Outcome measures

Outcome measures
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 Participants BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 Participants Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=23 Participants BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 Participants Placebo: Intramuscular injection
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1	12 Participants	11 Participants	0 Participants	3 Participants	8 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2	18 Participants	23 Participants	0 Participants	11 Participants	18 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2	24 Participants	24 Participants	0 Participants	21 Participants	22 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-S1 IgG antibody - 7 days after dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-S1 IgG antibody - 21 days after dose 1	24 Participants	24 Participants	0 Participants	21 Participants	22 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-S1 IgG antibody - 7 days after dose 2	24 Participants	24 Participants	0 Participants	22 Participants	23 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-S1 IgG antibody - 21 days after dose 2	24 Participants	24 Participants	0 Participants	23 Participants	23 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-RBD IgG antibody - 7 days after dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-RBD IgG antibody - 21 days after dose 1	24 Participants	24 Participants	0 Participants	22 Participants	22 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-RBD IgG antibody - 7 days after dose 2	24 Participants	24 Participants	0 Participants	23 Participants	23 Participants	0 Participants
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline SCR of anti-RBD IgG antibody - 21 days after dose 2	24 Participants	24 Participants	0 Participants	23 Participants	23 Participants	0 Participants

Adverse Events

Low-dose 10 µg, 18-55 Years of Age

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

High-dose 30 µg, 18-55 Years of Age

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo, 18-55 Years of Age

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Low-dose 10 µg, 65-85 Years of Age

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

High-dose 30 µg, 65-85 Years of Age

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo, 65-85 Years of Age

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 participants at risk Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 participants at risk Placebo: Intramuscular injection
Endocrine disorders Hyperthyroidism	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Endocrine disorders Thyroid mass	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Congenital, familial and genetic disorders Thyroglossal cyst	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.

Other adverse events

Other adverse events
Measure	Low-dose 10 µg, 18-55 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	High-dose 30 µg, 18-55 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	Placebo, 18-55 Years of Age n=24 participants at risk Placebo: Intramuscular injection	Low-dose 10 µg, 65-85 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	High-dose 30 µg, 65-85 Years of Age n=24 participants at risk BNT162b1: Intramuscular injection	Placebo, 65-85 Years of Age n=24 participants at risk Placebo: Intramuscular injection
General disorders Vaccination site pain	87.5% 21/24 • Number of events 36 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	95.8% 23/24 • Number of events 42 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	66.7% 16/24 • Number of events 25 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	87.5% 21/24 • Number of events 34 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Pyrexia	58.3% 14/24 • Number of events 14 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	87.5% 21/24 • Number of events 33 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	29.2% 7/24 • Number of events 8 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	79.2% 19/24 • Number of events 31 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Fatigue	54.2% 13/24 • Number of events 16 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	66.7% 16/24 • Number of events 23 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	33.3% 8/24 • Number of events 10 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Malaise	33.3% 8/24 • Number of events 8 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	37.5% 9/24 • Number of events 12 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 5 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Vaccination site erythema	25.0% 6/24 • Number of events 7 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	33.3% 8/24 • Number of events 11 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Vaccination site swelling	20.8% 5/24 • Number of events 5 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	29.2% 7/24 • Number of events 9 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	20.8% 5/24 • Number of events 5 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Chills	16.7% 4/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	29.2% 7/24 • Number of events 9 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 5 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Temperature intolerance	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	25.0% 6/24 • Number of events 7 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 5 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Vaccination site discomfort	12.5% 3/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Vaccination site pruritus	8.3% 2/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Vaccination site induration	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Pain	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Chest pain	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Peripheral swelling	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
General disorders Vaccination site rash	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Nervous system disorders Headache	45.8% 11/24 • Number of events 12 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	79.2% 19/24 • Number of events 25 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Nervous system disorders Dizziness	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	25.0% 6/24 • Number of events 7 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 4/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	41.7% 10/24 • Number of events 14 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 2/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	41.7% 10/24 • Number of events 14 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Nausea	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 5 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Diarrhoea	8.3% 2/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Vomiting	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Eructation	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Haemorrhoids	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Gastrointestinal disorders Toothache	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Metabolism and nutrition disorders Decreased appetite	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	16.7% 4/24 • Number of events 4 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Infections and infestations Nasopharyngitis	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	12.5% 3/24 • Number of events 3 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Infections and infestations Cervicitis	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Infections and infestations Urethritis	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Infections and infestations Urinary tract infection	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Blood and lymphatic system disorders Lymphadenopathy	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Blood and lymphatic system disorders Neutropenia	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Injury, poisoning and procedural complications Limb injury	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Injury, poisoning and procedural complications Wound	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Investigations Blood uric acid increased	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	8.3% 2/24 • Number of events 2 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Investigations Blood pressure increased	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Cardiac disorders Palpitations	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Ear and labyrinth disorders Tinnitus	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Endocrine disorders Hypothyroidism	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Hepatobiliary disorders Hepatic failure	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Renal and urinary disorders Nephrolithiasis	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Renal and urinary disorders Dysuria	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Renal and urinary disorders Micturition urgency	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Renal and urinary disorders Pollakiuria	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.
Eye disorders Swelling of eyelid	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	4.2% 1/24 • Number of events 1 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.	0.00% 0/24 • From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose) Treatment-emergent AEs (TEAEs) are presented, including solicited and unsolicited AEs. An TEAE is defined as any AE with an onset date on or after the first dose (if the AE was absent before the first dose) or worsened after the first dose (if the AE was present before the first dose). AEs with an onset date more than 28 days after the last dose will be considered as treatment emergent only if assessed as related to the vaccine (BNT162b1 or placebo) by the investigator.

Additional Information

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