Document text
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1003
10031122
(USA/48/M)* Placebo Dose 2/77 05NOV2020 24NOV2020 Neg/Neg/Neg Fever Pos/Neg, 06NOV2020
New or increased
cough
Chills
C4591001 1003
10031167 (USA/57/F)* Placebo Dose 2/67 02NOV2020 11DEC2020 Neg/Neg/Neg New or increased
coughNeg/, 06NOV2020
New or increased
shortness of breath
Sore throa t
Dose 2/112 17DEC2020 16JAN2021 Neg/Neg/Neg Feve r Pos/Pos, 19DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1003
10031186 (USA/33/M) Placebo Dose 2/101 12DEC2020 24DEC2020 Neg/Neg/Neg Fever Pos/Pos, 14DEC2020
New or increased
cough
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 1
FDA-CBER-2021-5683-0220585
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1003
10031204 (USA/39/F)* Placebo Dose 2/95 07DEC2020 12JAN2021 Neg/Neg/Neg New or increased
coughPos/Pos, 11DEC2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1005
10051341 (USA/23/F) Placebo Dose 1/2 22OCT2020 08NOV2020 Neg/Pos/Neg New or increased
coughPos/, 24OCT2020
New or increased
shortness of breath
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1005
10051358 (USA/52/F)* Placebo Dose 2/59 10JAN2021 20JAN2021 Neg/Neg/Neg Fever Pos/, 12JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 2
FDA-CBER-2021-5683-0220586
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Sore throa t
C4591001 1005
10051360
(USA/77/M)* Placebo Dose 2/29 10DEC2020 26DEC2020 Neg/Neg/Neg Fever Pos/, 12DEC2020
New or increased
cough
Sore throa t
C4591001 1005
10051403 (USA/66/F) BNT162b2 (30
μg) Dose 1/4 07NOV2020 13NOV2020 Neg/Neg/Pos New or increased
coughPos/, 09NOV2020
New or increased
muscle pain
Sore throa t
C4591001 1006
10061012
(USA/53/M)* Placebo Dose 2/68 06NOV2020 16NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 06NOV2020
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
C4591001 1006
10061025 (USA/65/F)* Placebo Dose 2/82 21NOV2020 02DEC2020 Neg/Neg/Neg New or increased
coughPos/, 24NOV2020
New or increased
shortness of breath
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 3
FDA-CBER-2021-5683-0220587
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1006
10061066 (USA/39/F)* Placebo Dose 2/59 11NOV2020 Neg/Neg/Neg New or increased
coughPos/, 11NOV2020
Sore throa t
C4591001 1006
10061075 (USA/42/F)* Placebo Dose 2/69 16NOV2020 04JAN2021 Neg/Neg/Neg New or increased
muscle painPos/, 16NOV2020
Sore throa t
C4591001 1006
10061076 (USA/61/F)* Placebo Dose 2/123 11JAN2021 16JAN2021 Neg/Neg/Neg New or increased
shortness of breathPos/, 12JAN2021
Sore throa t
C4591001 1006
10061084 (USA/27/F)* Placebo Dose 2/48 27OCT2020 10NOV2020 Neg/Neg/Neg Fever Pos/, 28OCT2020
New or increased
cough
C4591001 1006
10061091 (USA/20/F)* Placebo Dose 2/50 30OCT2020 10NOV2020 Neg/Neg/Neg New or increased
coughPos/, 01NOV2020
Sore throa t
C4591001 1006
10061114
(USA/21/M)* Placebo Dose 2/35 20OCT2020 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 23OCT2020
New or increased
shortness of breath
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 4
FDA-CBER-2021-5683-0220588
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1006
10061186 (USA/16/M) Placebo Dose 2/6 26DEC2020 14JAN2021 Neg/Neg/Neg Fever Pos/, 30DEC2020
New or increased
muscle pain
Sore throa t
C4591001 1006
10061206
(USA/12/M)* Placebo Dose 2/10 01JAN2021 03JAN2021 Neg/Neg/Neg Fever Pos/, 01JAN2021
C4591001 1006
10061215 (USA/16/M) Placebo Dose 1/24 27DEC2020 10JAN2021 Neg/Neg/Pos New or increased
muscle painPos/, 28DEC2020
Sore throa t
C4591001 1006
10061259 (USA/15/F) Placebo Dose 2/7 11JAN2021 24JAN2021 Neg/Neg/Neg Fever Pos/, 18JAN2021
New or increased
cough
C4591001 1006
10061260 (USA/12/F)* Placebo Dose 2/17 21JAN2021 27JAN2021 Neg/Neg/Neg Sore throat Pos/, 21JAN2021
C4591001 1006
10061284 (USA/14/M) Placebo Dose 2/8 15JAN2021 16JAN2021 Neg/Neg/Pos Diarrhea Pos/, 18JAN2021
C4591001 1007
10071163 (USA/80/F)* Placebo Dose 2/76 14NOV2020 28NOV2020 Neg/Neg/Neg New or increased
coughPos/, 27NOV2020
C4591001 1007
10071246 (USA/30/F)* Placebo Dose 2/129 16JAN2021 19JAN2021 Neg/Neg/Neg Sore throat Pos/, 19JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 5
FDA-CBER-2021-5683-0220589
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1007
10071306 (USA/58/F)* Placebo Dose 2/60 31DEC2020 16JAN2021 Neg/Neg/Neg New or increased
coughPos/, 01JAN2021
New or increased
shortness of breath
Chills
Sore throa t
Diarrhea
C4591001 1007
10071407 (USA/41/M) Placebo Dose 1/12 02NOV2020 12NOV2020 Neg/Neg/Pos New or increased
coughPos/, 06NOV2020
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1007
10071409 (USA/13/M) BNT162b2 (30
μg) Dose 1/10 31OCT2020 04NOV2020 Neg/Neg/Neg Fever Pos/, 02NOV2020
C4591001 1007
10071425 (USA/50/F)* Placebo Dose 2/25 06DEC2020 11DEC2020 Neg/Neg/Neg Sore throat Pos/, 11DEC2020
C4591001 1007
10071448
(USA/16/M)* Placebo Dose 2/46 16JAN2021 24JAN2021 Neg/Neg/Neg Fever Pos/, 19JAN2021
C4591001 1007
10071456 (USA/17/F)* Placebo Dose 2/35 10JAN2021 14JAN2021 Neg/Neg/Neg Sore throat Pos/, 13JAN2021
C4591001 1007
10071505 (USA/12/F) Placebo Dose 2/2 29DEC2020 08JAN2021 Neg/Neg/Pos New loss of taste or
smellPos/, 03JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 6
FDA-CBER-2021-5683-0220590
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1007
10071527 (USA/12/M) Placebo Dose 2/10 07JAN2021 10JAN2021 Neg/Neg/Pos Sore throat Pos/Pos, 10JAN2021
C4591001 1007
10071559 (USA/14/F)* Placebo Dose 2/11 14JAN2021 26JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021
Sore throa t
C4591001 1007
10071603
(USA/13/M)* Placebo Dose 2/35 22FEB2021 28FEB2021 Neg/Neg/Neg Fever Pos/, 23FEB2021
New loss of taste or
smell
Sore throa t
C4591001 1007
10071622 (USA/15/M) BNT162b2 (30
μg) Dose 1/2 31DEC2020 15FEB2021 Neg/Neg/Neg New or increased
muscle painPos/, 04JAN2021
New loss of taste or
smell
C4591001 1007
10071642 (USA/15/M) BNT162b2 (30
μg) Dose 1/7 10JAN2021 20JAN2021 Neg/Neg/Pos New or increased
coughPos/, 12JAN2021
Sore throa t
C4591001 1008
10081011 (USA/55/F)* Placebo Dose 2/52 22OCT2020 31OCT2020 Neg/Neg/Neg New loss of taste or
smellPos/, 26OCT2020
C4591001 1008
10081015
(USA/33/M)* Placebo Dose 2/97 07DEC2020 12DEC2020 Neg/Neg/Neg New or increased
muscle pain Pos/, 14DEC2020
Sore throa t
C4591001 1008
10081044 (USA/58/F)* Placebo Dose 2/66 12NOV2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 7
FDA-CBER-2021-5683-0220591
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
shortness of breath
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1008
10081048 (USA/38/F)* Placebo Dose 2/60 07NOV2020 27NOV2020 Neg/Neg/Neg New or increased
coughPos/, 11NOV2020
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1008
10081060 (USA/71/F)* Placebo Dose 2/78 25NOV2020 04DEC2020 Neg/Neg/Neg New or increased
coughPos/, 01DEC2020
New loss of taste or
smell
C4591001 1008
10081069 (USA/57/F)* Placebo Dose 2/97 15DEC2020 22DEC2020 Neg/Neg/Neg New or increased
coughPos/, 16DEC2020
Sore throa t
C4591001 1008
10081092 (USA/62/F)* Placebo Dose 2/76 29NOV2020 12DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020
New or increased
cough
Sore throa t
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 8
FDA-CBER-2021-5683-0220592
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1008
10081103 (USA/35/F)* Placebo Dose 2/86 10DEC2020 17DEC2020 Neg/Neg/Neg Fever Pos/, 17DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1008
10081123 (USA/57/F)* Placebo Dose 2/103 28DEC2020 22JAN2021 Neg/Neg/Neg New or increased
coughPos/, 30DEC2020
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1008
10081130 (USA/52/F)* Placebo Dose 2/32 17OCT2020 29OCT2020 Neg/Neg/Neg New or increased
shortness of breathPos/, 23OCT2020
C4591001 1008
10081145
(USA/78/M)* Placebo Dose 2/97 26DEC2020 31DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 30DEC2020
C4591001 1008
10081153 (USA/31/F)* Placebo Dose 2/71 01DEC2020 04DEC2020 Neg/Neg/Neg New or increased
coughPos/, 02DEC2020
New loss of taste or
smell
C4591001 1008
10081210 (USA/57/F)* Placebo Dose 2/58 25NOV2020 13DEC2020 Neg/Neg/Neg New or increased
coughPos/, 30NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 9
FDA-CBER-2021-5683-0220593
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1008
10081214
(USA/62/M)* Placebo Dose 2/42 09NOV2020 13NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1008
10081232 (USA/53/F)* Placebo Dose 2/79 16DEC2020 27DEC2020 Neg/Neg/Neg New or increased
coughPos/, 18DEC2020
Sore throa t
C4591001 1008
10081281 (USA/20/F)* Placebo Dose 2/99 06JAN2021 19JAN2021 Neg/Neg/Neg New or increased
coughPos/, 08JAN2021
New or increased
muscle pain
New loss of taste or
smell
C4591001 1008
10081285 (USA/60/F)* Placebo Dose 2/57 27NOV2020 06DEC2020 Neg/Neg/Neg New or increased
coughPos/, 27NOV2020
New or increased
shortness of breath
C4591001 1008
10081319 (USA/79/F)* Placebo Dose 2/31 04NOV2020 08NOV2020 Neg/Neg/Neg Chills Pos/, 06NOV2020
C4591001 1008
10081338 (USA/53/M) Placebo Dose 2/1 06OCT2020 16OCT2020 Neg/Neg/Neg Fever Pos/, 08OCT2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 10
FDA-CBER-2021-5683-0220594
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1008
10081356
(USA/63/M)* Placebo Dose 2/25 31OCT2020 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 04NOV2020
New loss of taste or
smell
C4591001 1008
10081415
(USA/56/M)* Placebo Dose 2/53 04DEC2020 14DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 07DEC2020
C4591001 1008
10081493
(USA/19/M)* Placebo Dose 2/47 29NOV2020 04DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 01DEC2020
Chills
New or increased
muscle pain
C4591001 1008
10081529 (USA/38/M) BNT162b2 (30
μg) Dose 1/2 26SEP2020 Neg/Neg/Un k New or increased
coughPos/, 29SEP2020
New loss of taste or
smell
Sore throa t
C4591001 1008
10081563
(USA/72/M)* Placebo Dose 2/14 08NOV2020 20NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/, 17NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 11
FDA-CBER-2021-5683-0220595
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1008
10081580 (USA/38/M) Placebo Dose 2/7 03NOV2020 12NOV2020 Neg/Neg/Neg New or increased
muscle painPos/, 04NOV2020
New loss of taste or
smell
C4591001 1008
10081596 (USA/38/F)* Placebo Dose 2/61 02JAN2021 09JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021
New or increased
cough
Chills
C4591001 1008
10081612 (USA/38/F)* Placebo Dose 2/24 27NOV2020 05DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020
New or increased
cough
Chills
C4591001 1008
10081639 (USA/63/M) Placebo Dose 1/6 24OCT2020 11NOV2020 Neg/Neg/Neg New or increased
coughPos/, 26OCT2020
Sore throa t
C4591001 1008
10081644 (USA/65/M) Placebo Dose 2/1 10NOV2020 24NOV2020 Neg/Neg/Pos Fever Pos/, 13NOV2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
Vomitin g
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 12
FDA-CBER-2021-5683-0220596
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1008
10081664 (USA/49/F)* Placebo Dose 2/22 02DEC2020 14DEC2020 Neg/Neg/Neg New or increased
coughPos/, 04DEC2020
Sore throa t
C4591001 1008
10081721 (USA/37/F) Placebo Dose 1/13 10NOV2020 19NOV2020 Neg/Neg/Pos New loss of taste or
smellPos/, 11NOV2020
Sore throa t
C4591001 1008
10081725 (USA/68/M) Placebo Dose 1/18 15NOV2020 20NOV2020 Neg/Neg/Pos Fever Pos/, 18NOV2020
New or increased
cough
C4591001 1008
10081871 (USA/14/F) Placebo Dose 1/14 12JAN2021 19JAN2021 Neg/Neg/Neg New or increased
coughPos/, 18JAN2021
Sore throa t
C4591001 1008
10081884 (USA/15/F) Placebo Dose 1/19 18JAN2021 26JAN2021 Neg/Neg/Pos Sore throat Pos/, 20JAN2021
C4591001 1009
10091005
(USA/31/M)* Placebo Dose 2/66 06NOV2020 11NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/, 03NOV2020
C4591001 1009
10091018
(USA/70/M)* Placebo Dose 2/89 01DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 04DEC2020
New loss of taste or
smell
C4591001 1009
10091102 (USA/22/F)* Placebo Dose 2/115 08JAN2021 20JAN2021 Neg/Neg/Neg New loss of taste or
smellPos/, 13JAN2021
C4591001 1009
10091110 (USA/46/F)* Placebo Dose 2/69 21NOV2020 09DEC2020 Neg/Neg/Neg New or increased
coughPos/, 20NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 13
FDA-CBER-2021-5683-0220597
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
C4591001 1009
10091114 (USA/77/F)* Placebo Dose 2/105 27DEC2020 15JAN2021 Neg/Neg/Neg New or increased
coughPos/, 31DEC2020
Diarrhea
C4591001 1009
10091115
(USA/78/M)* Placebo Dose 2/108 30DEC2020 17JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 04JAN2021
C4591001 1009
10091128
(USA/51/M)* Placebo Dose 2/30 15OCT2020 24FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 20OCT2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1009
10091129
(USA/38/M)* BNT162b2 (30
μg) Dose 2/135 28JAN2021 Neg/Neg/Neg Fever Pos/, 08FEB2021
New or increased
cough
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 14
FDA-CBER-2021-5683-0220598
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1009
10091153 (USA/68/M) Placebo Dose 2/66 29NOV2020 06DEC2020 Unk/Neg/Neg New or increased
coughPos/, 01DEC2020
Sore throa t
C4591001 1009
10091208
(USA/15/M)* Placebo Dose 2/66 10JAN2021 14JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 10JAN2021
New or increased
shortness of breath
New or increased
muscle pain
Sore throa t
C4591001 1009
10091211 (USA/44/F) Placebo Dose 1/19 03NOV2020 02DEC2020 Neg/Neg/Neg New or increased
coughPos/, 03NOV2020
Chills
Sore throa t
C4591001 1009
10091214 (USA/47/F)* Placebo Dose 2/24 27NOV2020 09DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 30NOV2020
C4591001 1009
10091235
(USA/16/M)* Placebo Dose 2/17 27NOV2020 01DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 30NOV2020
Sore throa t
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 15
FDA-CBER-2021-5683-0220599
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1009
10091236 (USA/45/F)* Placebo Dose 2/16 26NOV2020 03DEC2020 Neg/Neg/Neg Sore throat Pos/, 30NOV2020
C4591001 1009
10091257 (USA/21/F) Placebo Dose 1/10 05NOV2020 01DEC2020 Neg/Neg/Pos New or increased
coughPos/, 06NOV2020
New or increased
shortness of breath
Chills
C4591001 1009
10091282
(USA/14/M)* Placebo Dose 2/42 01FEB2021 02FEB2021 Neg/Neg/Neg Chills Pos/, 02FEB2021
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1009
10091338 (USA/15/F) Placebo Dose 1/19 01JAN2021 24FEB2021 Neg/Neg/Pos Fever Pos/, 02JAN2021
New or increased
cough
New or increased
muscle pain
Sore throa t
C4591001 1009
10091366 (USA/14/F) Placebo Dose 1/9 25DEC2020 01JAN2021 Neg/Neg/Pos Fever Pos/, 28DEC2020
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 16
FDA-CBER-2021-5683-0220600
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1009
10091412
(USA/15/M)* Placebo Dose 2/29 01MAR2021 Neg/Neg/Neg New or increased
cough Pos/, 01MAR2021
Sore throa t
C4591001 1011
10111085 (USA/57/F) Placebo Dose 2/67 15NOV2020 05DEC2020 Neg/Neg/Neg Fever Pos/, 16NOV2020
New or increased
cough
Sore throa t
C4591001 1011
10111086 (USA/59/M) Placebo Dose 2/64 12NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020
New or increased
cough
Sore throa t
C4591001 1011
10111148 (USA/39/F) Placebo Dose 2/6 06OCT2020 05NOV2020 Neg/Neg/Neg New or increased
coughNeg/ (R1 Pos),
(09NOV2020)
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1011
10111174 (USA/24/M) Placebo Dose 2/7 04NOV2020 14NOV2020 Neg/Neg/Neg Fever Pos/, 05NOV2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 17
FDA-CBER-2021-5683-0220601
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Sore throa t
C4591001 1012
10121006
(USA/52/M)* Placebo Dose 2/71 06NOV2020 23NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 15NOV2020
C4591001 1012
10121042
(USA/63/M)* Placebo Dose 2/71 18NOV2020 Neg/Neg/Neg Fever Pos/, 23NOV2020
New or increased
cough
New loss of taste or
smell
Diarrhea
C4591001 1012
10121059 (USA/28/F)* Placebo Dose 2/95 13DEC2020 10FEB2021 Neg/Neg/Neg New or increased
coughPos/, 15DEC2020
New or increased
shortness of breath
New loss of taste or
smell
Sore throa t
C4591001 1012
10121164
(USA/37/M)* Placebo Dose 2/84 23DEC2020 02JAN2021 Neg/Neg/Neg Fever Pos/, 24DEC2020
New or increased
cough
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 18
FDA-CBER-2021-5683-0220602
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1013
10131014
(USA/29/M)* Placebo Dose 2/131 29DEC2020 05JAN2021 Neg/Neg/Neg Fever Pos/, 05JAN2021
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 1013
10131064 (USA/28/F)* Placebo Dose 2/155 25JAN2021 03FEB2021 Neg/Neg/Neg Fever Pos/, 28JAN2021
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1013
10131166 (USA/50/M) Placebo Dose 2/117 28DEC2020 13JAN2021 Neg/Neg/Un k New or increased
coughPos/, 05JAN2021
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 19
FDA-CBER-2021-5683-0220603
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1013
10131167 (USA/50/F)* Placebo Dose 2/119 30DEC2020 13JAN2021 Neg/Neg/Neg Chills Pos/, 05JAN2021
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1013
10131257 (USA/61/F)* Placebo Dose 2/89 11DEC2020 30DEC2020 Neg/Neg/Neg New or increased
coughPos/, 13DEC2020
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
Vomitin g
C4591001 1013
10131288
(USA/53/M)* Placebo Dose 2/11 25SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/, 28SEP2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 20
FDA-CBER-2021-5683-0220604
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1013
10131296
(USA/44/M)* Placebo Dose 2/72 25NOV2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1013
10131396
(USA/41/M)* Placebo Dose 2/75 05DEC2020 09DEC2020 Neg/Neg/Neg New loss of taste or
smell Pos/, 08DEC2020
C4591001 1013
10131398 (USA/36/M) Placebo Dose 2/86 16DEC2020 21DEC2020 Pos/Neg/Neg New or increased
coughPos/, 17DEC2020
Chills
Sore throa t
C4591001 1013
10131409
(USA/35/M)* Placebo Dose 2/90 21DEC2020 03JAN2021 Neg/Neg/Neg Fever Pos/, 30DEC2020
New or increased
cough
Chills
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 21
FDA-CBER-2021-5683-0220605
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1013
10131460 (USA/56/F)* BNT162b2 (30
μg) Dose 2/93 30DEC2020 27JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1013
10131471
(USA/20/M)* Placebo Dose 2/46 13NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 17NOV2020
Chills
New or increased
muscle pain
C4591001 1013
10131475 (USA/49/F)* Placebo Dose 2/23 22OCT2020 25OCT2020 Neg/Neg/Neg New or increased
coughPos/, 26OCT2020
New or increased
muscle pain
Sore throa t
C4591001 1013
10131539 (USA/70/F)* Placebo Dose 2/94 07JAN2021 17JAN2021 Neg/Neg/Neg New or increased
coughPos/, 08JAN2021
Sore throa t
C4591001 1013
10131540
(USA/71/M)* Placebo Dose 2/91 04JAN2021 06JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021
Chills
C4591001 1013
10131670
(USA/41/M)† BNT162b2 (30
μg) Dose 1/4 11OCT2020 21NOV2020 Neg/Pos/Neg New loss of taste or
smell Pos/, 14OCT2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 22
FDA-CBER-2021-5683-0220606
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1013
10131720
(USA/55/M)* BNT162b2 (30
μg) Dose 2/93 05FEB2021 03MAR2021 Neg/Neg/Neg New or increased
cough Pos/, 09FEB2021
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
Vomitin g
C4591001 1013
10131758
(USA/60/M)* Placebo Dose 2/48 28DEC2020 Neg/Neg/Neg New or increased
shortness of breath Pos/, 30DEC2020
Chills
New or increased
muscle pain
C4591001 1013
10131832 (USA/17/M) Placebo Dose 1/1 02DEC2020 17DEC2020 Neg/Neg/Neg New or increased
coughPos/, 09DEC2020
Chills
Sore throa t
C4591001 1013
10131834 (USA/17/M) BNT162b2 (30
μg) Dose 1/7 08DEC2020 16DEC2020 Neg/Neg/Neg Fever Pos/, 15DEC2020
New or increased
cough
Chills
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 23
FDA-CBER-2021-5683-0220607
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1015
10151094 (USA/50/F)* Placebo Dose 2/123 14JAN2021 Neg/Neg/Neg Fever Pos/, 19JAN2021
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1016
10161003 (USA/23/F)* Placebo Dose 2/57 14OCT2020 26OCT2020 Neg/Neg/Neg Fever Pos/, 16OCT2020
New or increased
cough
Chills
New loss of taste or
smell
C4591001 1016
10161004 (USA/51/F)* BNT162b2 (30
μg) Dose 2/58 15OCT2020 22OCT2020 Neg/Neg/Neg New loss of taste or
smellPos/, 17OCT2020
Sore throa t
C4591001 1016
10161017 (USA/18/F)* Placebo Dose 2/19 07SEP2020 29OCT2020 Neg/Neg/Neg Fever Pos/, 09SEP2020
Chills
New or increased
muscle pain
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 24
FDA-CBER-2021-5683-0220608
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1016
10161035 (USA/70/F)* Placebo Dose 2/67 29OCT2020 29OCT2020 Neg/Neg/Neg New or increased
coughPos/, 30OCT2020
C4591001 1016
10161048 (USA/52/F)* Placebo Dose 2/75 06NOV2020 31JAN2021 Neg/Neg/Neg New or increased
coughPos/, 06NOV2020
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1016
10161114 (USA/22/F)* BNT162b2 (30
μg) Dose 2/122 02JAN2021 08JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021
New or increased
muscle pain
C4591001 1016
10161123 (USA/48/F)* Placebo Dose 2/98 09DEC2020 25DEC2020 Neg/Neg/Neg Fever Pos/, 11DEC2020
Chills
C4591001 1016
10161146 (USA/59/F)* Placebo Dose 2/89 07DEC2020 20DEC2020 Neg/Neg/Neg Fever Pos/, 10DEC2020
New or increased
cough
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1016
10161183 (USA/31/F)* Placebo Dose 2/32 16OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/ (R1 Pos),
16OCT2020
(23OCT2020)
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 25
FDA-CBER-2021-5683-0220609
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
Vomitin g
C4591001 1016
10161207 (USA/62/F)* Placebo Dose 2/27 14OCT2020 01NOV2020 Neg/Neg/Neg New or increased
coughPos/, 16OCT2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1016
10161209 (USA/33/F)* Placebo Dose 2/98 28DEC2020 05JAN2021 Neg/Neg/Neg New or increased
muscle painPos/, 04JAN2021
C4591001 1016
10161305 (USA/16/M) Placebo Dose 2/8 09NOV2020 13NOV2020 Neg/Neg/Pos New or increased
coughPos/, 11NOV2020
New loss of taste or
smell
C4591001 1016
10161316 (USA/15/M) Placebo Dose 1/17 01NOV2020 11NOV2020 Neg/Neg/Pos New or increased
coughPos/, 02NOV2020
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 26
FDA-CBER-2021-5683-0220610
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1016
10161317
(USA/17/M)* Placebo Dose 2/51 26DEC2020 03JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 29DEC2020
New or increased
muscle pain
C4591001 1016
10161319 (USA/12/F) Placebo Dose 2/6 09NOV2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
New or increased
cough
Chills
New loss of taste or
smell
Sore throa t
C4591001 1016
10161341 (USA/44/F) BNT162b2 (30
μg) Dose 1/10 31OCT2020 15NOV2020 Neg/Neg/Pos New or increased
coughPos/, 02NOV2020
New or increased
shortness of breath
Sore throa t
Diarrhea
C4591001 1016
10161379 (USA/13/M) Placebo Dose 1/13 19JAN2021 02FEB2021 Neg/Neg/Neg New or increased
muscle pain Pos/ (R1 Pos),
19JAN2021
(29JAN2021)
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 27
FDA-CBER-2021-5683-0220611
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1018
10181083
(USA/45/M)* Placebo Dose 2/72 06NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 15NOV2020
New or increased
cough
Chills
New or increased
muscle pain
Diarrhea
Vomitin g
C4591001 1018
10181107 (USA/26/F)* BNT162b2 (30
μg) Dose 2/125 02JAN2021 Neg/Neg/Neg New or increased
coughPos/, 05JAN2021
New loss of taste or
smell
C4591001 1018
10181198 (USA/50/F)* Placebo Dose 2/55 04NOV2020 05NOV2020 Neg/Neg/Neg Fever Pos/, 05NOV2020
New or increased
cough
C4591001 1018
10181289
(USA/49/M)* Placebo Dose 2/88 31DEC2020 13JAN2021 Neg/Neg/Neg Fever Pos/, 03JAN2021
New or increased
cough
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 28
FDA-CBER-2021-5683-0220612
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1019
10191038 (USA/47/F)* Placebo Dose 2/61 03NOV2020 18NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020
New or increased
cough
New loss of taste or
smell
Diarrhea
C4591001 1019
10191184
(USA/52/M)* Placebo Dose 2/36 05NOV2020 08DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 05NOV2020
New or increased
muscle pain
Vomitin g
C4591001 1019
10191200
(USA/67/M)* Placebo Dose 2/77 22DEC2020 19JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 28DEC2020
C4591001 1019
10191242 (USA/28/F)* Placebo Dose 2/70 29DEC2020 05JAN2021 Neg/Neg/Neg Fever Pos/, 31DEC2020
New or increased
cough
New loss of taste or
smell
C4591001 1019
10191251
(USA/19/M)* Placebo Dose 2/45 06DEC2020 16DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 10DEC2020
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 29
FDA-CBER-2021-5683-0220613
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1019
10191256
(USA/49/M)* Placebo Dose 2/41 08DEC2020 15DEC2020 Neg/Neg/Neg Fever Pos/, 11DEC2020
New or increased
cough
Chills
Sore throa t
C4591001 1021
10211093
(USA/72/M)* Placebo Dose 2/99 21DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 10JAN2021
C4591001 1021
10211122 (USA/57/F)* Placebo Dose 2/114 12JAN2021 12FEB2021 Neg/Neg/Neg New or increased
coughPos/, 14JAN2021
Sore throa t
C4591001 1022
10221053 (USA/64/F)* Placebo Dose 2/112 03JAN2021 10JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021
New or increased
muscle pain
Vomitin g
C4591001 1024
10241080
(USA/54/M)* Placebo Dose 2/142 03FEB2021 21FEB2021 Neg/Neg/Neg Chills Pos/, 04FEB2021
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1024
10241092 (USA/53/F)* Placebo Dose 2/86 10DEC2020 13DEC2020 Neg/Neg/Neg New or increased
coughPos/, 11DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 30
FDA-CBER-2021-5683-0220614
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1024
10241130
(USA/65/M)† Placebo Dose 1/9 28OCT2020 01NOV2020 Neg/Neg/Pos Fever Pos/, 29OCT2020
New or increased
muscle pain
C4591001 1027
10271086 (USA/46/F)* Placebo Dose 2/77 03DEC2020 18DEC2020 Neg/Neg/Neg New or increased
coughPos/, 07DEC2020
Sore throa t
C4591001 1027
10271202 (USA/57/F)* Placebo Dose 2/68 19DEC2020 01JAN2021 Neg/Neg/Neg New or increased
coughPos/Pos, 21DEC2020
New or increased
muscle pain
C4591001 1028
10281038 (USA/53/F)* Placebo Dose 2/31 10OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/, 13OCT2020
New or increased
cough
Sore throa t
C4591001 1028
10281054
(USA/51/M)* Placebo Dose 2/63 16NOV2020 18DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 20NOV2020
Chills
C4591001 1028
10281057
(USA/63/M)* Placebo Dose 2/93 29DEC2020 08JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 30DEC2020
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 31
FDA-CBER-2021-5683-0220615
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1028
10281100 (USA/47/F)* Placebo Dose 2/19 11OCT2020 21OCT2020 Neg/Neg/Neg New or increased
coughPos/, 13OCT2020
C4591001 1028
10281122 (USA/44/F)* Placebo Dose 2/53 15NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 18NOV2020
New or increased
cough
Chills
New or increased
muscle pain
Vomitin g
C4591001 1028
10281132
(USA/61/M)* Placebo Dose 2/14 11OCT2020 21OCT2020 Neg/Neg/Neg Fever Pos/, 13OCT2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1028
10281138 (USA/38/F)* Placebo Dose 2/25 23OCT2020 03NOV2020 Neg/Neg/Neg Fever Pos/, 27OCT2020
Chills
Sore throa t
Diarrhea
C4591001 1028
10281152
(USA/51/M)* Placebo Dose 2/94 30DEC2020 06JAN2021 Neg/Neg/Neg Fever Pos/, 02JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 32
FDA-CBER-2021-5683-0220616
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1028
10281187
(USA/82/M)* Placebo Dose 2/59 09DEC2020 30DEC2020 Neg/Neg/Neg New loss of taste or
smell Pos/, 09DEC2020
C4591001 1028
10281193 (USA/60/F) Placebo Dose 2/7 14OCT2020 09NOV2020 Neg/Neg/Neg New or increased
coughPos/, 22OCT2020
Chills
C4591001 1028
10281229 (USA/45/M) Placebo Dose 2/3 17OCT2020 25OCT2020 Neg/Neg/Neg New or increased
coughPos/, 18OCT2020
Chills
New loss of taste or
smell
Sore throa t
Vomitin g
C4591001 1028
10281250 (USA/18/M) Placebo Dose 1/11 18OCT2020 23OCT2020 Neg/Neg/Pos Sore throat Pos/, 22OCT2020
C4591001 1028
10281269 (USA/29/F)* Placebo Dose 2/9 19NOV2020 24NOV2020 Neg/Neg/Neg Fever Pos/, 19NOV2020
New or increased
cough
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 33
FDA-CBER-2021-5683-0220617
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1028
10281285 (USA/26/F) Placebo Dose 1/22 17NOV2020 25NOV2020 Neg/Neg/Neg New or increased
coughPos/, 20NOV2020
New or increased
muscle pain
Sore throa t
C4591001 1028
10281294 (USA/23/F) Placebo Dose 1/7 04NOV2020 11NOV2020 Neg/Neg/Pos New or increased
coughPos/, 04NOV2020
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1030
10301025 (USA/66/F)* Placebo Dose 2/85 15DEC2020 24DEC2020 Neg/Neg/Neg Sore throat Pos/, 16DEC2020
C4591001 1030
10301048
(USA/33/M)* Placebo Dose 2/74 05DEC2020 11DEC2020 Neg/Neg/Neg New or increased
muscle pain Pos/, 06DEC2020
Sore throa t
C4591001 1030
10301069 (USA/29/F)* Placebo Dose 2/64 04DEC2020 10DEC2020 Neg/Neg/Neg New or increased
coughPos/, 05DEC2020
New loss of taste or
smell
C4591001 1030
10301088 (USA/39/F)* Placebo Dose 2/87 30DEC2020 12JAN2021 Neg/Neg/Neg Fever Pos/, 02JAN2021
New or increased
cough
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 34
FDA-CBER-2021-5683-0220618
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1030
10301113 (USA/30/F)* Placebo Dose 2/35 12NOV2020 17NOV2020 Neg/Neg/Neg New or increased
coughPos/, 19NOV2020
New loss of taste or
smell
Diarrhea
C4591001 1030
10301123 (USA/45/F)* Placebo Dose 2/64 15DEC2020 30DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 21DEC2020
Sore throa t
C4591001 1030
10301156 (USA/61/F) Placebo Dose 2/5 13NOV2020 20NOV2020 Neg/Neg/Neg New or increased
coughPos/, 15NOV2020
New or increased
muscle pain
C4591001 1036
10361035
(USA/63/M)* BNT162b2 (30
μg) Dose 2/71 24NOV2020 29NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 01DEC2020
New loss of taste or
smell
Diarrhea
C4591001 1036
10361078 (USA/20/M) Placebo Dose 2/2 01OCT2020 Neg/Neg/Pos New loss of taste or
smellPos/, 22OCT2020
C4591001 1037
10371004 (USA/57/F)* Placebo Dose 2/69 16NOV2020 03FEB2021 Neg/Neg/Neg Chills Pos/, 19NOV2020
C4591001 1037
10371016
(USA/84/M)* Placebo Dose 2/88 05DEC2020 11DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 10DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 35
FDA-CBER-2021-5683-0220619
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1037
10371036
(USA/62/M)* Placebo Dose 2/52 31OCT2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 05NOV2020
New or increased
cough
Chills
C4591001 1037
10371113 (USA/71/F)* Placebo Dose 2/70 29NOV2020 09DEC2020 Neg/Neg/Neg Fever Pos/, 02DEC2020
New or increased
cough
Chills
C4591001 1037
10371146
(USA/78/M)* Placebo Dose 2/96 27DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 30DEC2020
New or increased
shortness of breath
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1037
10371155 (USA/55/M) Placebo Dose 2/75 12DEC2020 Unk/Neg/Neg Fever Pos/, 14DEC2020
New or increased
cough
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 36
FDA-CBER-2021-5683-0220620
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1037
10371187
(USA/78/M)* Placebo Dose 2/69 06DEC2020 14DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 14DEC2020
Chills
C4591001 1037
10371193 (USA/76/F)* Placebo Dose 2/36 05NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 17NOV2020
New or increased
shortness of breath
Chills
Diarrhea
C4591001 1037
10371200 (USA/29/F)* Placebo Dose 2/70 15DEC2020 27DEC2020 Neg/Neg/Neg New or increased
coughPos/, 16DEC2020
New or increased
shortness of breath
Sore throa t
C4591001 1037
10371280
(USA/58/M)* Placebo Dose 2/28 10NOV2020 04DEC2020 Neg/Neg/Neg Fever Pos/, 11NOV2020
New or increased
cough
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 37
FDA-CBER-2021-5683-0220621
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Diarrhea
C4591001 1037
10371307 (USA/43/F)* Placebo Dose 2/59 16DEC2020 25DEC2020 Neg/Neg/Neg New or increased
coughPos/, 18DEC2020
New or increased
muscle pain
C4591001 1037
10371323 (USA/48/F)* Placebo Dose 2/36 02DEC2020 06DEC2020 Neg/Neg/Neg New or increased
coughPos/, 02DEC2020
New or increased
muscle pain
C4591001 1037
10371353
(USA/37/M)* Placebo Dose 2/18 28NOV2020 21DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
New loss of taste or
smell
Diarrhea
C4591001 1038
10381044 (USA/32/F) Placebo Dose 2/79 02DEC2020 13DEC2020 Pos/Neg/Neg New or increased
shortness of breathPos/, 07DEC2020
Chills
C4591001 1038
10381051
(USA/69/M)* Placebo Dose 2/51 07NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 38
FDA-CBER-2021-5683-0220622
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
New or increased
shortness of breath
Sore throa t
C4591001 1038
10381103 (USA/43/F) Placebo Dose 2/5 04OCT2020 03NOV2020 Neg/Neg/Neg New loss of taste or
smellPos/, 08OCT2020
C4591001 1039
10391021 (USA/26/F) Placebo Dose 1/1 25AUG2020 14SEP2020 Neg/Pos/Pos Fever Pos/, 28AUG2020
New or increased
cough
New or increased
shortness of breath
New loss of taste or
smell
Sore throa t
C4591001 1039
10391025 (USA/55/F)* Placebo Dose 2/40 25OCT2020 15NOV2020 Neg/Neg/Neg Sore throat Pos/, 28OCT2020
C4591001 1039
10391244 (USA/17/M) Placebo Dose 1/13 23NOV2020 30NOV2020 Neg/Neg/Neg Fever Pos/, 30NOV2020
New or increased
cough
Chills
C4591001 1039
10391268 (USA/13/F)* Placebo Dose 2/33 29JAN2021 03MAR2021 Neg/Neg/Neg Fever Pos/, 29JAN2021
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 39
FDA-CBER-2021-5683-0220623
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
shortness of breath
Chills
New or increased
muscle pain
C4591001 1042
10421133 (USA/61/F)* Placebo Dose 2/142 28JAN2021 11FEB2021 Neg/Neg/Neg Fever Pos/, 01FEB2021
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1042
10421168 (USA/59/F)* Placebo Dose 2/76 30NOV2020 21DEC2020 Neg/Neg/Neg New or increased
coughPos/, 02DEC2020
New loss of taste or
smell
C4591001 1042
10421223 (USA/71/F)* Placebo Dose 2/90 27DEC2020 16JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020
New or increased
cough
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 40
FDA-CBER-2021-5683-0220624
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1044
10441138
(USA/63/M)* Placebo Dose 2/102 22JAN2021 23JAN2021 Neg/Neg/Neg Fever Pos/, 25JAN2021
C4591001 1044
10441167 (USA/42/F)* Placebo Dose 2/103 05FEB2021 25FEB2021 Neg/Neg/Neg New or increased
shortness of breathPos/, 09FEB2021
New loss of taste or
smell
C4591001 1044
10441242
(USA/17/M)* Placebo Dose 2/49 01FEB2021 07FEB2021 Neg/Neg/Neg Fever Pos/, 04FEB2021
Chills
New or increased
muscle pain
C4591001 1044
10441264 (USA/14/F) Placebo Dose 2/6 02JAN2021 Neg/Neg/Neg New or increased
coughPos/, 04JAN2021
Sore throa t
C4591001 1044
10441374
(USA/15/M)* Placebo Dose 2/13 14FEB2021 17FEB2021 Neg/Neg/Neg Chills Pos/, 16FEB2021
New loss of taste or
smell
Vomitin g
C4591001 1046
10461037
(USA/60/M)* BNT162b2 (30
μg) Dose 2/109 21DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 22DEC2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 41
FDA-CBER-2021-5683-0220625
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1046
10461058 (USA/44/F)* Placebo Dose 2/62 09NOV2020 16NOV2020 Neg/Neg/Neg New or increased
muscle painPos/, 09NOV2020
C4591001 1046
10461101 (USA/31/F)* Placebo Dose 2/98 21DEC2020 24DEC2020 Neg/Neg/Neg Fever Pos/, 21DEC2020
New or increased
cough
New or increased
muscle pain
C4591001 1046
10461124 (USA/36/F)* Placebo Dose 2/105 29DEC2020 04JAN2021 Neg/Neg/Neg Fever Pos/, 29DEC2020
New or increased
cough
New or increased
muscle pain
C4591001 1046
10461203 (USA/55/F)* Placebo Dose 2/53 23NOV2020 30NOV2020 Neg/Neg/Neg New or increased
coughPos/, 24NOV2020
New or increased
muscle pain
C4591001 1046
10461204
(USA/54/M)* Placebo Dose 2/55 23NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 24NOV2020
New or increased
cough
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 42
FDA-CBER-2021-5683-0220626
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1046
10461235
(USA/59/M)* BNT162b2 (30
μg) Dose 2/86 23DEC2020 29DEC2020 Neg/Neg/Neg Fever Pos/, 23DEC2020
New or increased
cough
New or increased
muscle pain
C4591001 1046
10461334 (USA/53/F)* Placebo Dose 2/28 16DEC2020 17DEC2020 Neg/Neg/Neg Fever Pos/, 16DEC2020
New or increased
muscle pain
New loss of taste or
smell
C4591001 1047
10471024 (USA/63/F)* BNT162b2 (30
μg) Dose 2/37 16OCT2020 18OCT2020 Neg/Neg/Neg Fever Pos/, 17OCT2020
Diarrhea
Vomitin g
C4591001 1047
10471079 (USA/21/F)* Placebo Dose 2/87 13DEC2020 25DEC2020 Neg/Neg/Neg Fever Pos/, 15DEC2020
Sore throa t
C4591001 1047
10471080 (USA/43/F)* Placebo Dose 2/56 12NOV2020 20NOV2020 Neg/Neg/Neg New loss of taste or
smellPos/Pos, 13NOV2020
C4591001 1047
10471170
(USA/63/M)* BNT162b2 (30
μg) Dose 2/62 01DEC2020 15JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 03DEC2020
C4591001 1047
10471217 (USA/49/F)* Placebo Dose 2/72 19DEC2020 22DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 22DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 43
FDA-CBER-2021-5683-0220627
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1047
10471252 (USA/63/M) Placebo Dose 1/22 12OCT2020 15NOV2020 Neg/Neg/Pos Fever Pos/, 14OCT2020
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1047
10471327
(USA/35/M)* Placebo Dose 2/59 09JAN2021 13JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021
New or increased
muscle pain
C4591001 1048
10481027
(USA/46/M)* Placebo Dose 2/112 05JAN2021 19JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 11JAN2021
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1048
10481064 (USA/52/F)* Placebo Dose 2/107 06JAN2021 10JAN2021 Neg/Neg/Neg Fever Pos/, 08JAN2021
New or increased
cough
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 44
FDA-CBER-2021-5683-0220628
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1048
10481104 (USA/57/F)* Placebo Dose 2/43 11NOV2020 16DEC2020 Neg/Neg/Neg Fever Pos/, 13NOV2020
Chills
New or increased
muscle pain
C4591001 1048
10481118 (USA/67/F)* Placebo Dose 2/32 02NOV2020 11NOV2020 Neg/Neg/Neg New or increased
coughPos/, 13NOV2020
New loss of taste or
smell
Sore throa t
C4591001 1052
10521082 (USA/38/F)* Placebo Dose 2/110 09JAN2021 10JAN2021 Neg/Neg/Neg Fever Pos/, 12JAN2021
C4591001 1052
10521110 (USA/53/F)* Placebo Dose 2/112 13JAN2021 13JAN2021 Neg/Neg/Neg New or increased
coughPos/, 13JAN2021
New or increased
muscle pain
Sore throa t
C4591001 1054
10541001 (USA/50/F)* Placebo Dose 2/134 19JAN2021 09FEB2021 Neg/Neg/Neg New or increased
coughPos/, 24JAN2021
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Vomitin g
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 45
FDA-CBER-2021-5683-0220629
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1054
10541002
(USA/51/M)* BNT162b2 (30
μg) Dose 2/134 19JAN2021 25JAN2021 Neg/Neg/Neg Fever Pos/, 26JAN2021
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1054
10541035
(USA/29/M)* BNT162b2 (30
μg) Dose 2/81 29NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 04DEC2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1054
10541038 (USA/27/F)* Placebo Dose 2/88 10DEC2020 04FEB2021 Neg/Neg/Neg Fever Pos/, 12DEC2020
New or increased
cough
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 46
FDA-CBER-2021-5683-0220630
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
C4591001 1054
10541137
(USA/42/M)* Placebo Dose 2/100 07JAN2021 13JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 08JAN2021
C4591001 1054
10541146 (USA/65/F)* BNT162b2 (30
μg) Dose 2/62 09DEC2020 12DEC2020 Neg/Neg/Neg New or increased
coughPos/, 11DEC2020
C4591001 1054
10541194 (USA/58/F)* Placebo Dose 2/29 03DEC2020 17DEC2020 Neg/Neg/Neg Sore throat Pos/ (R1 Pos),
05DEC2020
(04JAN2021)
C4591001 1054
10541202
(USA/57/M)* Placebo Dose 2/60 11JAN2021 Neg/Neg/Neg Fever Pos/, 12JAN2021
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1055
10551016 (USA/38/F)* BNT162b2 (30
μg) Dose 2/104 12DEC2020 18DEC2020 Neg/Neg/Neg Sore throat Pos/, 16DEC2020
C4591001 1055
10551099
(USA/30/M)* Placebo Dose 2/100 22DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 27DEC2020
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 47
FDA-CBER-2021-5683-0220631
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1055
10551123
(USA/67/M)* Placebo Dose 2/64 19NOV2020 29NOV2020 Neg/Neg/Neg Fever Pos/, 20NOV2020
New or increased
cough
C4591001 1055
10551203
(USA/49/M)* Placebo Dose 2/48 17NOV2020 27NOV2020 Neg/Neg/Neg New or increased
cough Pos/Pos, 18NOV2020
Chills
New or increased
muscle pain
C4591001 1055
10551228 (USA/39/F)* Placebo Dose 2/48 21NOV2020 14DEC2020 Neg/Neg/Neg Fever Pos/, 22NOV2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1055
10551243
(USA/18/M)* Placebo Dose 2/67 20DEC2020 29DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 22DEC2020
Chills
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 48
FDA-CBER-2021-5683-0220632
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1056
10561041 (USA/49/F)* BNT162b2 (30
μg) Dose 2/116 10JAN2021 01FEB2021 Neg/Neg/Neg New or increased
coughPos/, 15JAN2021
New loss of taste or
smell
C4591001 1056
10561098 (USA/51/F) Placebo Dose 2/85 11DEC2020 07JAN2021 Neg/Neg/Neg Fever Pos/, 15DEC2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1056
10561099 (USA/58/M) Placebo Dose 2/83 09DEC2020 07JAN2021 Neg/Neg/Neg New or increased
coughPos/, 15DEC2020
New or increased
muscle pain
C4591001 1056
10561349 (USA/59/F)* Placebo Dose 2/72 05JAN2021 13JAN2021 Neg/Neg/Neg Fever Pos/, 11JAN2021
New or increased
cough
New or increased
shortness of breath
New loss of taste or
smell
Sore throa t
C4591001 1056
10561502 (USA/64/F)* Placebo Dose 2/65 05JAN2021 17JAN2021 Neg/Neg/Neg New or increased
coughPos/, 07JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 49
FDA-CBER-2021-5683-0220633
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Sore throa t
C4591001 1056
10561514 (USA/30/F)* Placebo Dose 2/9 13NOV2020 18NOV2020 Neg/Neg/Neg Diarrhea Pos/, 17NOV2020
C4591001 1056
10561636 (USA/46/M) Placebo Dose 1/14 11NOV2020 28NOV2020 Neg/Neg/Un k Fever Pos/, 17NOV2020
New or increased
cough
C4591001 1057
10571238 (USA/49/F)* Placebo Dose 2/60 13DEC2020 21DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 15DEC2020
New loss of taste or
smell
Sore throa t
C4591001 1057
10571363 (USA/17/F)* Placebo Dose 2/48 24JAN2021 01FEB2021 Neg/Neg/Neg Fever Pos/, 26JAN2021
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1057
10571428 (USA/14/M) Placebo Dose 1/5 28DEC2020 02JAN2021 Neg/Neg/Pos Fever Pos/, 29DEC2020
Chills
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 50
FDA-CBER-2021-5683-0220634
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1066
10661050
(USA/59/M)* Placebo Dose 2/116 03JAN2021 18JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021
Chills
New or increased
muscle pain
Sore throa t
C4591001 1066
10661129 (USA/44/F)* Placebo Dose 2/73 28NOV2020 21DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 30NOV2020
C4591001 1066
10661163
(USA/24/M)* Placebo Dose 2/56 16NOV2020 28NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 18NOV2020
New loss of taste or
smell
C4591001 1066
10661167 (USA/50/F)* Placebo Dose 2/81 12DEC2020 05JAN2021 Neg/Neg/Neg New loss of taste or
smellPos/, 17DEC2020
C4591001 1066
10661176
(USA/61/M)* Placebo Dose 2/99 31DEC2020 03JAN2021 Neg/Neg/Neg Fever Pos/, 05JAN2021
New or increased
muscle pain
C4591001 1066
10661242
(USA/54/M)* Placebo Dose 2/90 30DEC2020 08JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021
New or increased
muscle pain
C4591001 1066
10661313 (USA/66/F)* Placebo Dose 2/34 17NOV2020 28NOV2020 Neg/Neg/Neg New or increased
coughPos/, 19NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 51
FDA-CBER-2021-5683-0220635
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Chills
New or increased
muscle pain
C4591001 1068
10681003 (USA/42/F)* Placebo Dose 2/108 25DEC2020 11JAN2021 Neg/Neg/Neg New or increased
coughPos/, 31DEC2020
New loss of taste or
smell
C4591001 1068
10681033 (USA/65/M) Placebo Dose 1/23 15SEP2020 23SEP2020 Neg/Neg/Pos Fever Pos/, 17SEP2020
New or increased
cough
Chills
New or increased
muscle pain
Diarrhea
C4591001 1068
10681037 (USA/22/F)* Placebo Dose 2/116 07JAN2021 09JAN2021 Neg/Neg/Neg Sore throat Pos/Pos, 12JAN2021
C4591001 1068
10681082
(USA/58/M)* Placebo Dose 2/42 01NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 02NOV2020
New or increased
cough
New or increased
shortness of breath
Sore throa t
C4591001 1068
10681083 (USA/26/F)* Placebo Dose 2/105 03JAN2021 08JAN2021 Neg/Neg/Neg New or increased
coughPos/Pos, 06JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 52
FDA-CBER-2021-5683-0220636
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1068
10681110 (USA/30/F)* Placebo Dose 2/22 16OCT2020 02NOV2020 Neg/Neg/Neg New or increased
coughPos/, 21OCT2020
New loss of taste or
smell
C4591001 1068
10681115
(USA/28/M)* Placebo Dose 2/93 31DEC2020 08JAN2021 Neg/Neg/Neg Sore throat Pos/Pos, 04JAN2021
C4591001 1071
10711022
(USA/47/M)* Placebo Dose 2/72 10NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 11NOV2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1071
10711028 (USA/54/F)* Placebo Dose 2/93 03DEC2020 09DEC2020 Neg/Neg/Neg Fever Pos/, 11DEC2020
New or increased
cough
New loss of taste or
smell
C4591001 1071
10711034 (USA/49/F)* Placebo Dose 2/111 20DEC2020 27DEC2020 Neg/Neg/Neg New or increased
coughPos/, 24DEC2020
New loss of taste or
smell
C4591001 1071
10711058 (USA/72/F)* Placebo Dose 2/60 06NOV2020 25NOV2020 Neg/Neg/Neg New or increased
coughPos/, 07NOV2020
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 53
FDA-CBER-2021-5683-0220637
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1071
10711147
(USA/70/M)* Placebo Dose 2/86 22DEC2020 24DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 27DEC2020
New or increased
muscle pain
C4591001 1071
10711197
(USA/61/M)* Placebo Dose 2/31 13NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020
Chills
C4591001 1071
10711198 (USA/54/F)* Placebo Dose 2/31 13NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020
New or increased
cough
C4591001 1071
10711216 (USA/64/F) Placebo Dose 1/4 12OCT2020 17OCT2020 Neg/Neg/Un k Fever Pos/, 13OCT2020
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throa t
C4591001 1071
10711228 (USA/66/F) BNT162b2 (30
μg) Dose 2/5 09NOV2020 26NOV2020 Neg/Neg/Pos Fever Pos/, 10NOV2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 54
FDA-CBER-2021-5683-0220638
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1071
10711249
(USA/44/M)* Placebo Dose 2/59 15JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 19JAN2021
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1072
10721004
(USA/59/M)* Placebo Dose 2/129 15JAN2021 12FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 20JAN2021
C4591001 1072
10721024 (USA/51/F)* BNT162b2 (30
μg) Dose 2/137 25JAN2021 Neg/Neg/Neg New or increased
coughPos/Pos, 26JAN2021
C4591001 1072
10721037 (USA/71/F) Placebo Dose 2/73 18DEC2020 02JAN2021 Neg/Neg/Neg Fever Pos/Pos, 21DEC2020
New or increased
cough
New or increased
shortness of breath
New loss of taste or
smell
C4591001 1072
10721051 (USA/47/F) Placebo Dose 1/12 06SEP2020 20SEP2020 Neg/Neg/Un k Fever Pos/, 10SEP2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 55
FDA-CBER-2021-5683-0220639
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1072
10721057
(USA/70/M)* Placebo Dose 2/41 26OCT2020 16NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 05NOV2020
C4591001 1072
10721064
(USA/77/M)* Placebo Dose 2/85 09DEC2020 26DEC2020 Neg/Neg/Neg Fever Pos/Pos, 15DEC2020
New or increased
cough
C4591001 1072
10721089 (USA/19/F)* Placebo Dose 2/157 26FEB2021 Neg/Neg/Neg New or increased
coughPos/, 01MAR2021
C4591001 1072
10721096
(USA/70/M)* Placebo Dose 2/93 31DEC2020 05FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 01JAN2021
Sore throa t
C4591001 1073
10731029 (USA/43/F)* Placebo Dose 2/104 07DEC2020 11DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 09DEC2020
C4591001 1073
10731036 (USA/50/F)* Placebo Dose 2/82 17NOV2020 02DEC2020 Neg/Neg/Neg Fever Pos/, 19NOV2020
New loss of taste or
smell
Sore throa t
C4591001 1073
10731060 (USA/78/F)* Placebo Dose 2/127 04JAN2021 10JAN2021 Neg/Neg/Neg Fever Pos/, 07JAN2021
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 56
FDA-CBER-2021-5683-0220640
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1073
10731067 (USA/24/F)* Placebo Dose 2/127 06JAN2021 09JAN2021 Neg/Neg/Neg New or increased
coughPos/, 08JAN2021
New or increased
muscle pain
C4591001 1073
10731068
(USA/39/M)* Placebo Dose 2/126 05JAN2021 08JAN2021 Neg/Neg/Neg New or increased
shortness of breath Pos/, 06JAN2021
Sore throa t
C4591001 1073
10731085 (USA/51/F)* Placebo Dose 2/105 14DEC2020 16DEC2020 Neg/Neg/Neg New or increased
coughPos/, 16DEC2020
New loss of taste or
smell
C4591001 1073
10731093 (USA/48/F)* BNT162b2 (30
μg) Dose 2/77 24NOV2020 05DEC2020 Neg/Neg/Neg Chills Pos/, 27NOV2020
New or increased
muscle pain
C4591001 1073
10731098
(USA/70/M)* Placebo Dose 2/100 16DEC2020 20DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 17DEC2020
C4591001 1073
10731103
(USA/49/M)* Placebo Dose 2/133 18JAN2021 22JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 20JAN2021
New loss of taste or
smell
C4591001 1073
10731123 (USA/73/F)* Placebo Dose 2/69 22NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 25NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 57
FDA-CBER-2021-5683-0220641
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1073
10731124
(USA/76/M)* Placebo Dose 2/67 20NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 25NOV2020
New or increased
muscle pain
Sore throa t
C4591001 1077
10771175
(USA/61/M)* Placebo Dose 2/85 15DEC2020 05JAN2021 Neg/Neg/Neg Fever Pos/, 21DEC2020
New or increased
cough
Chills
New loss of taste or
smell
C4591001 1077
10771176 (USA/61/F)* BNT162b2 (30
μg) Dose 2/90 20DEC2020 03JAN2021 Neg/Neg/Neg Fever Pos/, 21DEC2020
New or increased
cough
C4591001 1077
10771189
(USA/51/M)* Placebo Dose 2/51 11NOV2020 01DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 15NOV2020
Diarrhea
C4591001 1077
10771195 (USA/73/F)* Placebo Dose 2/40 01NOV2020 29NOV2020 Neg/Neg/Neg Fever Pos/, 07NOV2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 58
FDA-CBER-2021-5683-0220642
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1077
10771239
(USA/59/M)* Placebo Dose 2/58 04DEC2020 07DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020
New or increased
cough
New or increased
muscle pain
C4591001 1079
10791046 (USA/55/F)* Placebo Dose 2/62 26OCT2020 17DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 30OCT2020
C4591001 1079
10791054 (USA/28/F)* Placebo Dose 2/63 29OCT2020 14NOV2020 Neg/Neg/Neg New or increased
coughPos/, 30OCT2020
C4591001 1079
10791098
(USA/53/M)* Placebo Dose 2/111 22DEC2020 04JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 07JAN2021
Sore throa t
C4591001 1079
10791123 (USA/61/F)* Placebo Dose 2/135 13JAN2021 18JAN2021 Neg/Neg/Neg New or increased
coughPos/, 22JAN2021
New or increased
muscle pain
C4591001 1079
10791162 (USA/20/M) Placebo Dose 2/45 09OCT2020 17OCT2020 Neg/Neg/Neg Fever Pos/, 12OCT2020
Sore throa t
C4591001 1079
10791230 (USA/19/M) Placebo Dose 2/83 13DEC2020 20DEC2020 Neg/Pos/Neg New or increased
coughPos/, 18DEC2020
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 59
FDA-CBER-2021-5683-0220643
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1079
10791255
(USA/58/M)* Placebo Dose 2/96 01JAN2021 03JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021
Chills
C4591001 1079
10791257
(USA/45/M)* Placebo Dose 2/98 05JAN2021 08FEB2021 Neg/Neg/Neg Fever Pos/, 06JAN2021
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Diarrhea
C4591001 1079
10791296 (USA/40/F)* Placebo Dose 2/29 26NOV2020 10DEC2020 Neg/Neg/Neg New or increased
coughPos/Pos, 01DEC2020
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1080
10801135
(USA/28/M)* Placebo Dose 2/126 28JAN2021 17FEB2021 Neg/Neg/Neg Fever Pos/, 11FEB2021
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 60
FDA-CBER-2021-5683-0220644
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1081
10811014
(USA/63/M)* Placebo Dose 2/103 12DEC2020 20FEB2021 Neg/Neg/Neg New loss of taste or
smell Pos/, 15DEC2020
C4591001 1081
10811043 (USA/58/F)* Placebo Dose 2/90 06DEC2020 21DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 08DEC2020
C4591001 1081
10811077 (USA/50/F)* Placebo Dose 2/132 19JAN2021 02FEB2021 Neg/Neg/Neg Fever Pos/, 23JAN2021
New or increased
cough
Chills
C4591001 1081
10811086 (USA/45/F)* Placebo Dose 2/117 09JAN2021 05FEB2021 Neg/Neg/Neg Fever Pos/, 14JAN2021
New or increased
cough
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 61
FDA-CBER-2021-5683-0220645
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1081
10811151 (USA/79/F)* Placebo Dose 2/10 30SEP2020 14OCT2020 Neg/Neg/Neg New or increased
coughPos/, 14OCT2020
C4591001 1081
10811173
(USA/66/M)* Placebo Dose 2/99 31DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 04JAN2021
Diarrhea
C4591001 1081
10811196 (USA/48/F)* Placebo Dose 2/90 29DEC2020 26JAN2021 Neg/Neg/Neg New or increased
coughPos/, 31DEC2020
New loss of taste or
smell
Sore throa t
C4591001 1081
10811210
(USA/51/M)* BNT162b2 (30
μg) Dose 2/85 31DEC2020 21JAN2021 Neg/Neg/Neg New loss of taste or
smell Pos/ (R1 Pos),
02JAN2021
(03JAN2021)
C4591001 1082
10821016 (USA/46/F)* Placebo Dose 2/44 06OCT2020 27OCT2020 Neg/Neg/Neg Fever Pos/, 07OCT2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1082
10821026
(USA/48/M)* Placebo Dose 2/81 13NOV2020 24DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 18NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 62
FDA-CBER-2021-5683-0220646
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1082
10821143
(USA/41/M)* Placebo Dose 2/48 11NOV2020 05DEC2020 Neg/Neg/Neg Fever Pos/, 13NOV2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1082
10821162
(USA/72/M)* Placebo Dose 2/50 27NOV2020 23DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020
Chills
C4591001 1082
10821221 (USA/49/F) Placebo Dose 1/16 14NOV2020 10DEC2020 Neg/Neg/Un k New or increased
coughPos/, 19NOV2020
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1083
10831029 (USA/50/M) Placebo Dose 1/96 07NOV2020 12NOV2020 Neg/Neg/Un k New or increased
coughPos/, 09NOV2020
Chills
C4591001 1083
10831060 (USA/45/M) Placebo Dose 1/119 02DEC2020 17DEC2020 Neg/Neg/Un k Fever Pos/, 04DEC2020
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 63
FDA-CBER-2021-5683-0220647
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Diarrhea
C4591001 1083
10831181 (USA/35/F)* Placebo Dose 2/99 28DEC2020 03JAN2021 Neg/Neg/Neg New or increased
coughPos/, 30DEC2020
New or increased
shortness of breath
New loss of taste or
smell
C4591001 1084
10841016
(USA/43/M)* Placebo Dose 2/130 31DEC2020 05JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 07JAN2021
Sore throa t
C4591001 1084
10841089
(USA/28/M)* Placebo Dose 2/85 20NOV2020 02DEC2020 Neg/Neg/Neg Fever Pos/, 24NOV2020
New or increased
cough
C4591001 1084
10841188 (USA/48/F)* Placebo Dose 2/83 25NOV2020 07DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020
New or increased
cough
New or increased
shortness of breath
Vomitin g
C4591001 1084
10841302 (USA/65/F)* Placebo Dose 2/56 12NOV2020 30NOV2020 Neg/Neg/Neg New or increased
coughPos/, 16NOV2020
New or increased
shortness of breath
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 64
FDA-CBER-2021-5683-0220648
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1084
10841392 (USA/72/F)* Placebo Dose 2/80 25DEC2020 27DEC2020 Neg/Neg/Neg Fever Pos/, 29DEC2020
New or increased
cough
Chills
New loss of taste or
smell
C4591001 1085
10851004 (USA/49/F)* Placebo Dose 2/120 17DEC2020 18DEC2020 Neg/Neg/Neg Sore throat Pos/, 18DEC2020
C4591001 1085
10851027 (USA/50/F)* Placebo Dose 2/101 02DEC2020 25FEB2021 Neg/Neg/Neg New or increased
shortness of breathPos/, 04DEC2020
New or increased
muscle pain
C4591001 1085
10851177
(USA/70/M)* Placebo Dose 2/107 01JAN2021 05JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 05JAN2021
C4591001 1085
10851258
(USA/58/M)* Placebo Dose 2/100 30DEC2020 03JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021
C4591001 1085
10851286 (USA/52/F) Placebo Dose 1/24 02OCT2020 13OCT2020 Neg/Neg/Pos Sore throat Pos/, 06OCT2020
C4591001 1085
10851293 (USA/63/F)* Placebo Dose 2/37 07NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
New or increased
cough
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 65
FDA-CBER-2021-5683-0220649
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1085
10851347 (USA/77/F)* Placebo Dose 2/75 22DEC2020 29DEC2020 Neg/Neg/Neg New or increased
coughPos/, 29DEC2020
C4591001 1085
10851374 (USA/17/F)* Placebo Dose 2/48 03JAN2021 07JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021
Sore throa t
C4591001 1087
10871089 (USA/21/F) Placebo Dose 1/19 04SEP2020 30SEP2020 Neg/Neg/Un k Fever Pos/, 07SEP2020
C4591001 1087
10871209 (USA/50/F) BNT162b2 (30
μg) Dose 1/7 31AUG2020 03SEP2020 Neg/Neg/Un k Fever Pos/, 02SEP2020
New or increased
muscle pain
C4591001 1087
10871572
(USA/54/M)* Placebo Dose 2/88 31JAN2021 15FEB2021 Neg/Neg/Neg Fever Pos/, 01FEB2021
New or increased
cough
New or increased
muscle pain
C4591001 1088
10881011 (USA/48/F)* Placebo Dose 2/89 27NOV2020 19DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 66
FDA-CBER-2021-5683-0220650
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1088
10881016 (USA/50/F)* Placebo Dose 2/119 28DEC2020 02JAN2021 Neg/Neg/Neg New or increased
coughPos/, 29DEC2020
C4591001 1088
10881024 (USA/32/F)* Placebo Dose 2/96 06DEC2020 20DEC2020 Neg/Neg/Neg Fever Pos/, 09DEC2020
Chills
Sore throa t
C4591001 1088
10881075 (USA/68/F)* Placebo Dose 2/83 02DEC2020 13DEC2020 Neg/Neg/Neg New or increased
coughPos/, 07DEC2020
C4591001 1088
10881077 (USA/43/M) BNT162b2 (30
μg) Dose 2/83 02DEC2020 12DEC2020 Neg/Neg/Neg New or increased
coughPos/, 08DEC2020
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
C4591001 1088
10881086 (USA/69/F)* Placebo Dose 2/106 28DEC2020 04JAN2021 Neg/Neg/Neg Fever Pos/, 29DEC2020
New or increased
cough
New or increased
muscle pain
Sore throa t
C4591001 1088
10881091 (USA/66/F) Placebo Dose 2/132 25JAN2021 03MAR2021 Neg/Neg/Un k Fever Pos/, 28JAN2021
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 67
FDA-CBER-2021-5683-0220651
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1088
10881097
(USA/57/M)* Placebo Dose 2/83 07DEC2020 17DEC2020 Neg/Neg/Neg Fever Pos/, 08DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1088
10881126
(USA/65/M)* Placebo Dose 2/68 29NOV2020 01DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 30NOV2020
C4591001 1088
10881142 (USA/61/F)* Placebo Dose 2/94 25DEC2020 29DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 29DEC2020
C4591001 1088
10881148 (USA/28/F)* Placebo Dose 2/73 04DEC2020 10DEC2020 Neg/Neg/Neg Fever Pos/, 09DEC2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1088
10881164 (USA/58/F)* Placebo Dose 2/46 13NOV2020 03DEC2020 Neg/Neg/Neg New or increased
coughPos/, 18NOV2020
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 68
FDA-CBER-2021-5683-0220652
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1088
10881188 (USA/67/F)* Placebo Dose 2/84 21DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 23DEC2020
New or increased
muscle pain
C4591001 1088
10881219
(USA/63/M)* Placebo Dose 2/17 25OCT2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 26OCT2020
New or increased
cough
New or increased
muscle pain
C4591001 1088
10881233
(USA/47/M)* Placebo Dose 2/15 02NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/, 04NOV2020
New or increased
cough
Chills
Sore throa t
C4591001 1089
10891100 (USA/33/F)* Placebo Dose 2/115 24DEC2020 05FEB2021 Neg/Neg/Neg Fever Pos/, 28DEC2020
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1089
10891110 (USA/59/F)* Placebo Dose 2/158 04FEB2021 20FEB2021 Neg/Neg/Neg Fever Pos/, 11FEB2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 69
FDA-CBER-2021-5683-0220653
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Diarrhea
Vomitin g
C4591001 1089
10891115
(USA/55/M)* BNT162b2 (30
μg) Dose 2/140 21JAN2021 25FEB2021 Neg/Neg/Neg New loss of taste or
smell Pos/, 26JAN2021
C4591001 1089
10891217 (USA/64/F) BNT162b2 (30
μg) Dose 1/5 04SEP2020 12SEP2020 Neg/Neg/Pos New or increased
coughPos/, 11SEP2020
New or increased
shortness of breath
C4591001 1089
10891235 (USA/29/F)* Placebo Dose 2/47 08NOV2020 18NOV2020 Neg/Neg/Neg New or increased
coughPos/, 12NOV2020
Sore throa t
C4591001 1089
10891314 (USA/57/F)* Placebo Dose 2/56 30NOV2020 11DEC2020 Neg/Neg/Neg New or increased
coughPos/, 30NOV2020
Sore throa t
Diarrhea
C4591001 1090
10901022 (USA/52/F)* BNT162b2 (30
μg) Dose 2/114 19DEC2020 07JAN2021 Neg/Neg/Neg New loss of taste or
smellPos/, 31DEC2020
C4591001 1090
10901075
(USA/73/M)* Placebo Dose 2/96 01DEC2020 18DEC2020 Neg/Neg/Neg Diarrhea Pos/, 21DEC2020
C4591001 1090
10901086
(USA/55/M)* Placebo Dose 2/165 08FEB2021 Neg/Neg/Neg New or increased
muscle pain Pos/, 10FEB2021
C4591001 1090
10901121 (USA/58/F)* Placebo Dose 2/49 18OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/, 20OCT2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 70
FDA-CBER-2021-5683-0220654
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
C4591001 1090
10901278
(USA/46/M)* Placebo Dose 2/81 10DEC2020 22DEC2020 Neg/Neg/Neg Fever Pos/, 14DEC2020
New or increased
muscle pain
Diarrhea
C4591001 1090
10901349
(USA/53/M)* Placebo Dose 2/105 11JAN2021 16JAN2021 Neg/Neg/Neg New loss of taste or
smell Pos/, 12JAN2021
C4591001 1090
10901353
(USA/63/M)* Placebo Dose 2/40 08NOV2020 29NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020
New or increased
cough
C4591001 1090
10901528 (USA/53/F)* Placebo Dose 2/43 24DEC2020 24JAN2021 Neg/Neg/Neg New or increased
coughPos/, 28DEC2020
C4591001 1091
10911003
(USA/59/M)* Placebo Dose 2/135 01JAN2021 10JAN2021 Neg/Neg/Neg New or increased
muscle pain Pos/, 14JAN2021
C4591001 1091
10911014 (USA/52/M) Placebo Dose 2/76 03NOV2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 03NOV2020
Chills
Diarrhea
C4591001 1091
10911071 (USA/66/F)* Placebo Dose 2/164 10FEB2021 27FEB2021 Neg/Neg/Neg New or increased
coughPos/, 18FEB2021
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 71
FDA-CBER-2021-5683-0220655
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1091
10911119 (USA/44/F)* Placebo Dose 2/121 31DEC2020 21JAN2021 Neg/Neg/Neg Sore throat Pos/Pos, 05JAN2021
C4591001 1091
10911183
(USA/26/M)* Placebo Dose 2/62 17NOV2020 26NOV2020 Neg/Neg/Neg Fever Pos/, 18NOV2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1091
10911198
(USA/34/M)* Placebo Dose 2/93 17DEC2020 30DEC2020 Neg/Neg/Neg Fever Pos/, 18DEC2020
New or increased
cough
New or increased
muscle pain
New loss of taste or
smell
C4591001 1091
10911203
(USA/43/M)* Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Unk/Pos, 05NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 72
FDA-CBER-2021-5683-0220656
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1091
10911327 (USA/40/F)* Placebo Dose 2/38 18NOV2020 25NOV2020 Neg/Neg/Neg New or increased
coughPos/, 20NOV2020
New or increased
shortness of breath
New loss of taste or
smell
C4591001 1091
10911365 (USA/73/F)* Placebo Dose 2/50 24DEC2020 07JAN2021 Neg/Neg/Neg Fever Pos/, 26DEC2020
New or increased
cough
Sore throa t
Diarrhea
C4591001 1091
10911371
(USA/31/M)* Placebo Dose 2/14 24NOV2020 09DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 26NOV2020
New or increased
muscle pain
C4591001 1091
10911387 (USA/17/F) BNT162b2 (30
μg) Dose 1/2 06NOV2020 29JAN2021 Neg/Neg/Un k Fever Pos/, 08NOV2020
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1091
10911404 (USA/13/F)* Placebo Dose 2/27 23JAN2021 Neg/Neg/Neg New or increased
shortness of breathPos/, 25JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 73
FDA-CBER-2021-5683-0220657
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1091
10911407 (USA/12/M) Placebo Dose 2/6 02JAN2021 16JAN2021 Neg/Neg/Neg New or increased
coughPos/, 06JAN2021
New or increased
muscle pain
Diarrhea
C4591001 1092
10921021 (USA/60/F)* Placebo Dose 2/48 27OCT2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 29OCT2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1092
10921055 (USA/19/F)* Placebo Dose 2/88 10DEC2020 20DEC2020 Neg/Neg/Neg New or increased
coughPos/, 14DEC2020
New loss of taste or
smell
C4591001 1092
10921079
(USA/67/M)* Placebo Dose 2/122 15JAN2021 04FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 03FEB2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 74
FDA-CBER-2021-5683-0220658
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1092
10921089 (USA/63/F)* BNT162b2 (30
μg) Dose 2/101 25DEC2020 01JAN2021 Neg/Neg/Neg Chills Pos/, 27DEC2020
C4591001 1092
10921092
(USA/66/M)* Placebo Dose 2/66 21NOV2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 25NOV2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
Vomitin g
C4591001 1092
10921130
(USA/53/M)* Placebo Dose 2/18 09OCT2020 Neg/Neg/Neg Fever Pos/, 12OCT2020
New or increased
cough
New or increased
shortness of breath
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1092
10921158 (USA/23/M) Placebo Dose 1/10 12SEP2020 21SEP2020 Neg/Neg/Pos New or increased
coughPos/, 13SEP2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 75
FDA-CBER-2021-5683-0220659
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1092
10921176
(USA/68/M)* Placebo Dose 2/86 24DEC2020 17JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020
New or increased
cough
New loss of taste or
smell
C4591001 1092
10921242
(USA/69/M)* Placebo Dose 2/9 12NOV2020 10JAN2021 Neg/Neg/Neg New or increased
cough Pos/ (R1 Pos),
17NOV2020
(01DEC2020)
New or increased
muscle pain
New loss of taste or
smell
C4591001 1092
10921258 (USA/60/F)* Placebo Dose 2/52 01JAN2021 14JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
C4591001 1092
10921268 (USA/64/F) BNT162b2 (30
μg) Dose 1/2 23OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/, 26OCT2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 76
FDA-CBER-2021-5683-0220660
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1093
10931014 (USA/68/M) Placebo Dose 2/1 08SEP2020 16SEP2020 Neg/Neg/Neg New or increased
shortness of breathPos/, 16SEP2020
Chills
New or increased
muscle pain
C4591001 1093
10931019
(USA/28/M)* Placebo Dose 2/87 03DEC2020 12DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 04DEC2020
New or increased
shortness of breath
Chills
New loss of taste or
smell
Sore throa t
Diarrhea
Vomitin g
C4591001 1093
10931028
(USA/38/M)* Placebo Dose 2/69 17NOV2020 23NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 18NOV2020
Sore throa t
C4591001 1093
10931050 (USA/62/M) Placebo Dose 1/24 16SEP2020 10NOV2020 Neg/Neg/Un k New or increased
coughPos/, 21SEP2020
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 77
FDA-CBER-2021-5683-0220661
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1093
10931081 (USA/67/F)* Placebo Dose 2/19 05OCT2020 19OCT2020 Neg/Neg/Neg Sore throat Pos/, 06OCT2020
C4591001 1093
10931121 (USA/37/F) Placebo Dose 2/50 23NOV2020 01DEC2020 Neg/Neg/Neg New or increased
coughPos/, 30NOV2020
Chills
New loss of taste or
smell
C4591001 1093
10931148 (USA/21/F) Placebo Dose 2/1 12OCT2020 18OCT2020 Neg/Neg/Pos New loss of taste or
smellPos/, 13OCT2020
Diarrhea
C4591001 1093
10931177 (USA/55/F)* Placebo Dose 2/15 23NOV2020 27NOV2020 Neg/Neg/Neg New or increased
shortness of breathPos/, 30NOV2020
Chills
New or increased
muscle pain
C4591001 1093
10931189
(USA/74/M)* Placebo Dose 2/26 04DEC2020 15DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1093
10931199 (USA/47/M) Placebo Dose 2/5 17NOV2020 19NOV2020 Neg/Neg/Neg New or increased
shortness of breathPos/, 18NOV2020
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 78
FDA-CBER-2021-5683-0220662
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1093
10931216
(USA/35/M)* Placebo Dose 2/11 30NOV2020 02DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 02DEC2020
C4591001 1094
10941056 (USA/58/F)* Placebo Dose 2/68 21NOV2020 22DEC2020 Neg/Neg/Neg New or increased
coughPos/, 25NOV2020
C4591001 1094
10941163 (USA/53/F)* Placebo Dose 2/61 19DEC2020 19JAN2021 Neg/Neg/Neg Sore throat Pos/, 22DEC2020
C4591001 1094
10941171
(USA/71/M)* Placebo Dose 2/60 25DEC2020 12JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 28DEC2020
C4591001 1095
10951002 (USA/20/F)* Placebo Dose 2/140 07JAN2021 08JAN2021 Neg/Neg/Neg Fever Pos/, 11JAN2021
Chills
C4591001 1095
10951060
(USA/36/M)* Placebo Dose 2/104 08DEC2020 07JAN2021 Neg/Neg/Neg Fever Pos/, 09DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Diarrhea
Vomitin g
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 79
FDA-CBER-2021-5683-0220663
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1095
10951098 (USA/59/F)* Placebo Dose 2/71 06NOV2020 17DEC2020 Neg/Neg/Neg New or increased
coughPos/, 10NOV2020
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1095
10951117
(USA/70/M)* Placebo Dose 2/96 15DEC2020 02JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 19DEC2020
C4591001 1095
10951196
(USA/50/M)* Placebo Dose 2/88 18DEC2020 21DEC2020 Neg/Neg/Neg Fever Pos/, 21DEC2020
New or increased
cough
C4591001 1095
10951223
(USA/42/M)* Placebo Dose 2/95 27DEC2020 01JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 30DEC2020
New or increased
muscle pain
C4591001 1095
10951238 (USA/63/F)* Placebo Dose 2/19 02NOV2020 20DEC2020 Neg/Neg/Neg New or increased
coughPos/, 09NOV2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 80
FDA-CBER-2021-5683-0220664
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Diarrhea
C4591001 1095
10951260
(USA/25/M)* Placebo Dose 2/9 05NOV2020 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 09NOV2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1096
10961021 (USA/67/F)* Placebo Dose 2/98 08DEC2020 09JAN2021 Neg/Neg/Neg Chills Pos/, 18DEC2020
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1096
10961072
(USA/49/M)* Placebo Dose 2/98 22DEC2020 08JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 28DEC2020
Chills
C4591001 1096
10961164 (USA/62/F)* BNT162b2 (30
μg) Dose 2/104 29DEC2020 25JAN2021 Neg/Neg/Neg New or increased
shortness of breathPos/, 05JAN2021
New or increased
muscle pain
New loss of taste or
smell
C4591001 1096
10961172
(USA/51/M)* Placebo Dose 2/49 06NOV2020 08NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 81
FDA-CBER-2021-5683-0220665
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
C4591001 1096
10961258 (USA/55/F)* Placebo Dose 2/25 22OCT2020 26OCT2020 Neg/Neg/Neg New or increased
coughPos/Pos, 26OCT2020
New or increased
muscle pain
Sore throa t
C4591001 1096
10961388 (USA/17/F) Placebo Dose 1/4 12OCT2020 15OCT2020 Neg/Neg/Pos Sore throat Pos/, 14OCT2020
C4591001 1097
10971038
(USA/64/M)* Placebo Dose 2/79 04DEC2020 15DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 08DEC2020
Sore throa t
C4591001 1097
10971103 (USA/72/F) Placebo Dose 1/18 25SEP2020 03OCT2020 Neg/Neg/Pos Fever Pos/, 05OCT2020
New or increased
cough
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 1097
10971104 (USA/73/M) BNT162b2 (30
μg) Dose 1/18 25SEP2020 06OCT2020 Neg/Neg/Pos Fever Pos/, 05OCT2020
New or increased
cough
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 82
FDA-CBER-2021-5683-0220666
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1098
10981028
(USA/58/M)* Placebo Dose 2/102 21DEC2020 02JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 22DEC2020
New or increased
muscle pain
Sore throa t
C4591001 1098
10981029 (USA/36/M) BNT162b2 (30
μg) Dose 1/11 31AUG2020 01SEP2020 Neg/Neg/Un k Fever Pos/, 31AUG2020
C4591001 1098
10981046 (USA/66/F)* BNT162b2 (30
μg) Dose 2/70 23NOV2020 23NOV2020 Neg/Neg/Neg New or increased
coughPos/, 25NOV2020
C4591001 1098
10981058 (USA/69/F)* Placebo Dose 2/130 23JAN2021 06FEB2021 Neg/Neg/Neg Fever Pos/, 04FEB2021
New or increased
muscle pain
C4591001 1098
10981062 (USA/63/F)* Placebo Dose 2/32 17OCT2020 20OCT2020 Neg/Neg/Neg New or increased
muscle painPos/, 19OCT2020
C4591001 1098
10981187
(USA/23/M)* Placebo Dose 2/124 07FEB2021 18FEB2021 Neg/Neg/Neg Fever Pos/, 10FEB2021
Chills
New or increased
muscle pain
Sore throa t
C4591001 1098
10981216
(USA/52/M)* Placebo Dose 2/42 23NOV2020 29NOV2020 Neg/Neg/Neg Sore throat Pos/, 25NOV2020
C4591001 1101
11011024 (USA/54/F) Placebo Dose 1/11 19SEP2020 07OCT2020 Neg/Neg/Un k Fever Pos/, 01OCT2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 83
FDA-CBER-2021-5683-0220667
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
New or increased
muscle pain
C4591001 1101
11011041 (USA/54/F)* Placebo Dose 2/107 15JAN2021 21JAN2021 Neg/Neg/Neg New loss of taste or
smellPos/, 19JAN2021
C4591001 1101
11011095
(USA/60/M)* Placebo Dose 2/20 02NOV2020 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 04NOV2020
C4591001 1101
11011105 (USA/22/F)* Placebo Dose 2/18 19NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 24NOV2020
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1107
11071037
(USA/59/M)* Placebo Dose 2/124 26DEC2020 29JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 03JAN2021
New or increased
muscle pain
C4591001 1107
11071121
(USA/77/M)* Placebo Dose 2/98 14DEC2020 30DEC2020 Neg/Neg/Neg Chills Pos/, 27DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 84
FDA-CBER-2021-5683-0220668
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1107
11071170 (USA/61/F)* Placebo Dose 2/101 23DEC2020 02JAN2021 Neg/Neg/Neg Sore throat Pos/, 27DEC2020
C4591001 1107
11071171
(USA/39/M)* Placebo Dose 2/58 10NOV2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 11NOV2020
Chills
C4591001 1107
11071190 (USA/42/F)* Placebo Dose 2/82 13DEC2020 28DEC2020 Neg/Neg/Neg New or increased
coughPos/, 14DEC2020
New or increased
muscle pain
New loss of taste or
smell
C4591001 1109
11091067
(USA/42/M)* Placebo Dose 2/84 11NOV2020 28NOV2020 Neg/Neg/Neg New or increased
shortness of breath Pos/, 11NOV2020
Sore throa t
C4591001 1109
11091092
(USA/18/M)* Placebo Dose 2/70 31OCT2020 24NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
New or increased
cough
Sore throa t
C4591001 1109
11091147 (USA/46/F)* Placebo Dose 2/151 20JAN2021 26JAN2021 Neg/Neg/Neg Sore throat Pos/, 22JAN2021
C4591001 1109
11091229 (USA/69/F)* Placebo Dose 2/82 26NOV2020 12JAN2021 Neg/Neg/Neg New or increased
coughPos/, 28NOV2020
C4591001 1109
11091233 (USA/59/F)* BNT162b2 (30
μg) Dose 2/115 26DEC2020 28DEC2020 Neg/Neg/Neg Sore throat Pos/, 29DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 85
FDA-CBER-2021-5683-0220669
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1109
11091309 (USA/24/F)* Placebo Dose 2/124 11JAN2021 21JAN2021 Neg/Neg/Neg New or increased
coughPos/, 15JAN2021
New or increased
shortness of breath
New loss of taste or
smell
C4591001 1109
11091316
(USA/47/M)* Placebo Dose 2/115 05JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 08JAN2021
New or increased
shortness of breath
Chills
New or increased
muscle pain
C4591001 1109
11091323
(USA/64/M)* Placebo Dose 2/47 31OCT2020 02NOV2020 Neg/Neg/Neg Fever Pos/, 03NOV2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1109
11091346
(USA/64/M)* Placebo Dose 2/99 24DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 04JAN2021
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 86
FDA-CBER-2021-5683-0220670
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1109
11091415 (USA/48/F)* Placebo Dose 2/93 27DEC2020 18JAN2021 Neg/Neg/Neg Fever Pos/, 29DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
Sore throa t
C4591001 1109
11091416 (USA/46/F)* Placebo Dose 2/41 03NOV2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 11NOV2020
New or increased
cough
Sore throa t
C4591001 1109
11091448 (USA/46/F)* Placebo Dose 2/9 06OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/ (R1 Pos),
09OCT2020
(23OCT2020)
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throa t
C4591001 1109
11091482
(USA/63/M)* Placebo Dose 2/28 29OCT2020 13NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 03NOV2020
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220671
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1109
11091556 (USA/41/M) Placebo Dose 1/8 11OCT2020 16OCT2020 Neg/Neg/Neg New loss of taste or
smellPos/, 12OCT2020
C4591001 1110
11101006 (USA/34/F) BNT162b2 (30
μg) Dose 1/2 01AUG2020 16AUG2020 Neg/Neg/Pos New or increased
coughPos/, 11AUG2020
Chills
New loss of taste or
smell
Vomitin g
C4591001 1110
11101050
(USA/47/M)* BNT162b2 (30
μg) Dose 2/76 10NOV2020 12JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 12NOV2020
Chills
Sore throa t
C4591001 1110
11101072 (USA/42/M) Placebo Dose 2/4 28SEP2020 21JAN2021 Neg/Neg/Pos New loss of taste or
smellPos/, 01OCT2020
Sore throa t
Diarrhea
C4591001 1110
11101079 (USA/71/F)* Placebo Dose 2/88 28NOV2020 13DEC2020 Neg/Neg/Neg New or increased
coughPos/, 04DEC2020
New or increased
muscle pain
New loss of taste or
smell
C4591001 1110
11101108
(USA/58/M)* Placebo Dose 2/95 11DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 15DEC2020
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 88
FDA-CBER-2021-5683-0220672
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
New loss of taste or
smell
C4591001 1110
11101111
(USA/45/M)* Placebo Dose 2/108 25DEC2020 06JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 02JAN2021
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 1110
11101136
(USA/62/M)* Placebo Dose 2/52 04NOV2020 15JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 06NOV2020
Chills
Diarrhea
C4591001 1110
11101162
(USA/51/M)* BNT162b2 (30
μg) Dose 2/34 24OCT2020 04NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 26OCT2020
New loss of taste or
smell
C4591001 1110
11101232
(USA/62/M)* BNT162b2 (30
μg) Dose 2/113 21JAN2021 15FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 22JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220673
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
C4591001 1110
11101325 (USA/42/F)* Placebo Dose 2/75 04JAN2021 26JAN2021 Neg/Neg/Neg New or increased
coughPos/, 07JAN2021
New or increased
muscle pain
C4591001 1111
11111010
(USA/75/M)* Placebo Dose 2/45 04OCT2020 05OCT2020 Neg/Neg/Neg Fever Pos/, 06OCT2020
Chills
C4591001 1111
11111128 (USA/60/F)* Placebo Dose 2/127 12JAN2021 19JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021
New or increased
muscle pain
Sore throa t
C4591001 1111
11111150
(USA/57/M)* Placebo Dose 2/43 02NOV2020 17NOV2020 Neg/Neg/Neg Chills Pos/, 17NOV2020
New or increased
muscle pain
C4591001 1111
11111186
(USA/88/M)* Placebo Dose 2/79 29DEC2020 05JAN2021 Neg/Neg/Neg Sore throat Pos/, 05JAN2021
Diarrhea
C4591001 1112
11121003 (USA/64/F)* Placebo Dose 2/116 12DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 15DEC2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 90
FDA-CBER-2021-5683-0220674
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
Diarrhea
C4591001 1112
11121064
(USA/42/M)* Placebo Dose 2/131 02JAN2021 18JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 06JAN2021
Diarrhea
C4591001 1112
11121210 (USA/69/F) Placebo Dose 2/88 21DEC2020 06JAN2021 Neg/Neg/Neg New loss of taste or
smellPos/, 21DEC2020
C4591001 1112
11121224 (USA/45/F)* Placebo Dose 2/76 07DEC2020 28DEC2020 Neg/Neg/Neg New or increased
coughPos/, 15DEC2020
New loss of taste or
smell
C4591001 1112
11121245 (USA/41/F)* Placebo Dose 2/91 30DEC2020 02JAN2021 Neg/Neg/Neg New or increased
coughPos/, 04JAN2021
Chills
C4591001 1112
11121301
(USA/47/M)* Placebo Dose 2/27 28NOV2020 19DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 29NOV2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1114
11141008
(USA/22/M)* Placebo Dose 2/80 19NOV2020 23NOV2020 Neg/Neg/Neg Fever Pos/, 20NOV2020
C4591001 1114
11141014 (USA/20/F)* BNT162b2 (30
μg) Dose 2/123 01JAN2021 21JAN2021 Neg/Neg/Neg New or increased
coughPos/, 06JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 91
FDA-CBER-2021-5683-0220675
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1114
11141024 (USA/18/F)* Placebo Dose 2/126 07JAN2021 31JAN2021 Neg/Neg/Neg New or increased
coughPos/, 11JAN2021
C4591001 1114
11141075 (USA/40/F)* Placebo Dose 2/110 28DEC2020 16FEB2021 Neg/Neg/Neg Fever Pos/, 04JAN2021
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1116
11161072 (USA/52/F)* Placebo Dose 2/81 10DEC2020 Neg/Neg/Neg New or increased
coughPos/, 14DEC2020
New loss of taste or
smell
C4591001 1116
11161075
(USA/73/M)* Placebo Dose 2/43 03NOV2020 19JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 05NOV2020
New or increased
shortness of breath
Chills
C4591001 1116
11161104 (USA/38/F)* Placebo Dose 2/140 07FEB2021 01MAR2021 Neg/Neg/Neg New or increased
coughPos/, 09FEB2021
C4591001 1116
11161111 (USA/71/F)* Placebo Dose 2/111 12JAN2021 04FEB2021 Neg/Neg/Neg New or increased
coughPos/, 21JAN2021
C4591001 1116
11161160
(USA/47/M)* Placebo Dose 2/103 08JAN2021 18JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 13JAN2021
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 92
FDA-CBER-2021-5683-0220676
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
New loss of taste or
smell
C4591001 1116
11161184
(USA/77/M)* Placebo Dose 2/72 09DEC2020 24DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 15DEC2020
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1116
11161207 (USA/58/F)* Placebo Dose 2/64 02DEC2020 25DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1116
11161224 (USA/52/F)* Placebo Dose 2/46 14NOV2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220677
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1116
11161250 (USA/62/F)* Placebo Dose 2/55 01DEC2020 11DEC2020 Neg/Neg/Neg New or increased
coughPos/, 03DEC2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1116
11161253 (USA/61/M) Placebo Dose 1/8 25SEP2020 06OCT2020 Neg/Neg/Pos Fever Pos/, 28SEP2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1116
11161275 (USA/58/F)* Placebo Dose 2/80 01JAN2021 09JAN2021 Neg/Neg/Neg Fever Pos/, 03JAN2021
Chills
Diarrhea
C4591001 1116
11161283 (USA/72/F)* Placebo Dose 2/39 20NOV2020 02DEC2020 Neg/Neg/Neg Sore throat Pos/, 02DEC2020
C4591001 1116
11161322 (USA/23/M) Placebo Dose 2/7 20OCT2020 Neg/Neg/Neg Fever Pos/, 26OCT2020
New or increased
cough
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220678
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1117
11171010 (USA/72/F)* Placebo Dose 2/34 11OCT2020 19OCT2020 Neg/Neg/Neg Fever Pos/, 11OCT2020
New or increased
cough
C4591001 1117
11171028
(USA/67/M)* Placebo Dose 2/62 10NOV2020 01DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 13NOV2020
New or increased
muscle pain
C4591001 1117
11171031 (USA/74/F)* Placebo Dose 2/82 29NOV2020 07DEC2020 Neg/Neg/Neg Sore throat Pos/, 05DEC2020
C4591001 1117
11171120
(USA/60/M)* Placebo Dose 2/67 11DEC2020 16DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 15DEC2020
Chills
New loss of taste or
smell
C4591001 1117
11171121 (USA/34/F)* Placebo Dose 2/42 16NOV2020 11JAN2021 Neg/Neg/Neg New or increased
coughPos/, 22NOV2020
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 95
FDA-CBER-2021-5683-0220679
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1117
11171141 (USA/73/F)* Placebo Dose 2/53 04DEC2020 25DEC2020 Neg/Neg/Neg New or increased
coughPos/, 06DEC2020
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1117
11171173
(USA/61/M)* Placebo Dose 2/38 22NOV2020 09DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 30NOV2020
Sore throa t
C4591001 1118
11181014 (USA/38/F)* Placebo Dose 2/119 28DEC2020 13JAN2021 Neg/Neg/Neg New or increased
coughPos/, 30DEC2020
Chills
New loss of taste or
smell
Sore throa t
C4591001 1118
11181076 (USA/33/F)* Placebo Dose 2/110 27DEC2020 08JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220680
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Diarrhea
C4591001 1118
11181088
(USA/73/M)* Placebo Dose 2/36 20OCT2020 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 29OCT2020
New or increased
muscle pain
C4591001 1120
11201091 (USA/67/F)* Placebo Dose 2/135 15JAN2021 19JAN2021 Neg/Neg/Neg Fever Pos/, 20JAN2021
New or increased
muscle pain
C4591001 1120
11201101 (USA/48/F)* Placebo Dose 2/133 04JAN2021 07FEB2021 Neg/Neg/Neg New or increased
coughPos/, 06JAN2021
New or increased
muscle pain
Diarrhea
Vomitin g
C4591001 1120
11201115 (USA/19/F)* Placebo Dose 2/73 06NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1120
11201154 (USA/35/F)* Placebo Dose 2/168 17FEB2021 Neg/Neg/Neg Fever Pos/, 19FEB2021
C4591001 1120
11201191
(USA/23/M)* Placebo Dose 2/86 26NOV2020 28NOV2020 Neg/Neg/Neg Fever Pos/, 27NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220681
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Chills
Sore throa t
C4591001 1120
11201335 (USA/63/F) Placebo Dose 1/8 23OCT2020 11NOV2020 Neg/Neg/Pos Fever Pos/, 26OCT2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Diarrhea
C4591001 1120
11201339 (USA/41/F) Placebo Dose 2/1 04NOV2020 23NOV2020 Neg/Neg/Neg New or increased
coughPos/, 10NOV2020
New or increased
muscle pain
Sore throa t
C4591001 1120
11201353 (USA/59/F)* Placebo Dose 2/98 18FEB2021 10MAR2021 Neg/Neg/Neg New or increased
coughPos/, 04MAR2021
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1120
11201374 (USA/71/F)* Placebo Dose 2/49 28DEC2020 04JAN2021 Neg/Neg/Neg New or increased
coughPos/, 30DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220682
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1121
11211069
(USA/45/M)* Placebo Dose 2/71 01DEC2020 20DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 04DEC2020
C4591001 1121
11211070 (USA/43/F)* Placebo Dose 2/56 16NOV2020 20DEC2020 Neg/Neg/Neg New or increased
coughPos/, 27NOV2020
New or increased
muscle pain
C4591001 1121
11211094
(USA/28/M)* Placebo Dose 2/86 23DEC2020 Neg/Neg/Neg New or increased
shortness of breath Pos/, 23DEC2020
New loss of taste or
smell
C4591001 1121
11211105
(USA/52/M)* Placebo Dose 2/39 05NOV2020 10DEC2020 Neg/Neg/Neg Fever Pos/, 06NOV2020
New or increased
cough
Sore throa t
C4591001 1122
11221025
(USA/40/M)* Placebo Dose 2/32 01NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 03NOV2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220683
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1123
11231025 (USA/60/F)* Placebo Dose 2/77 08NOV2020 13DEC2020 Neg/Neg/Neg New or increased
coughPos/, 11NOV2020
New loss of taste or
smell
Sore throa t
C4591001 1123
11231073 (USA/25/F)* Placebo Dose 2/10 10SEP2020 25SEP2020 Neg/Neg/Neg New or increased
coughPos/Pos, 11SEP2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1123
11231085 (USA/20/M) Placebo Dose 1/4 16AUG2020 27AUG2020 Neg/Neg/Pos New or increased
muscle painPos/, 17AUG2020
C4591001 1123
11231086 (USA/35/F)* Placebo Dose 2/57 27OCT2020 18NOV2020 Neg/Neg/Neg New or increased
coughPos/, 28OCT2020
New or increased
muscle pain
C4591001 1123
11231102 (USA/52/F)* Placebo Dose 2/88 28NOV2020 11DEC2020 Neg/Neg/Neg Diarrhea Pos/, 01DEC2020
C4591001 1123
11231103
(USA/63/M)* BNT162b2 (30
μg) Dose 2/105 15DEC2020 26DEC2020 Neg/Neg/Neg Fever Pos/, 23DEC2020
New or increased
cough
Diarrhea
C4591001 1123
11231117 (USA/55/F)* Placebo Dose 2/64 10NOV2020 22NOV2020 Neg/Neg/Neg Chills Pos/, 11NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 100
FDA-CBER-2021-5683-0220684
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1123
11231123 (USA/47/F)* Placebo Dose 2/84 01DEC2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
Vomitin g
C4591001 1123
11231132 (USA/32/F)* Placebo Dose 2/99 15DEC2020 26DEC2020 Neg/Neg/Neg New or increased
coughPos/, 16DEC2020
Chills
New or increased
muscle pain
C4591001 1123
11231144 (USA/53/F) BNT162b2 (30
μg) Dose 1/9 28AUG2020 19SEP2020 Neg/Neg/Un k Fever Pos/, 30AUG2020
New or increased
cough
New or increased
shortness of breath
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220685
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Sore throa t
C4591001 1123
11231156 (USA/33/F)* Placebo Dose 2/55 07NOV2020 30NOV2020 Neg/Neg/Neg New or increased
coughPos/, 12NOV2020
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
C4591001 1123
11231182
(USA/65/M)* Placebo Dose 2/108 30DEC2020 08JAN2021 Neg/Neg/Neg New loss of taste or
smell Pos/, 30DEC2020
Sore throa t
C4591001 1123
11231214 (USA/60/F)* Placebo Dose 2/34 26OCT2020 01DEC2020 Neg/Neg/Neg New or increased
coughPos/, 05NOV2020
New or increased
shortness of breath
Chills
New loss of taste or
smell
Sore throa t
C4591001 1123
11231232 (USA/39/F)* BNT162b2 (30
μg) Dose 2/83 21DEC2020 08JAN2021 Neg/Neg/Neg New or increased
shortness of breathPos/, 23DEC2020
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220686
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1123
11231234
(USA/29/M)* Placebo Dose 2/32 02NOV2020 12NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 03NOV2020
New or increased
muscle pain
Sore throa t
C4591001 1123
11231255
(USA/76/M)* Placebo Dose 2/20 24OCT2020 01NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 02NOV2020
C4591001 1123
11231256 (USA/72/F)* Placebo Dose 2/20 24OCT2020 25NOV2020 Neg/Neg/Neg New or increased
coughPos/, 02NOV2020
C4591001 1123
11231284
(USA/67/M)* Placebo Dose 2/12 24OCT2020 24NOV2020 Neg/Neg/Neg Fever Pos/, 26OCT2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1123
11231313 (USA/42/F) Placebo Dose 1/13 06OCT2020 01NOV2020 Neg/Neg/Pos Fever Pos/, 07OCT2020
New or increased
cough
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220687
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
C4591001 1123
11231339 (USA/35/F)* Placebo Dose 2/38 02DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 09DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1123
11231357 (USA/51/F)* Placebo Dose 2/44 11DEC2020 18FEB2021 Neg/Neg/Neg New or increased
coughPos/, 15DEC2020
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1123
11231386 (USA/33/F) BNT162b2 (30
μg) Dose 1/8 26OCT2020 09NOV2020 Neg/Neg/Pos Fever Pos/, 02NOV2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 104
FDA-CBER-2021-5683-0220688
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1123
11231501 (USA/12/F) Placebo Dose 1/18 14JAN2021 02FEB2021 Neg/Neg/Neg Fever Pos/, 19JAN2021
New or increased
cough
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1124
11241007 (USA/60/F)* Placebo Dose 2/85 23NOV2020 03DEC2020 Neg/Neg/Neg Fever Pos/, 24NOV2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1124
11241052 (USA/39/F)* Placebo Dose 2/101 18DEC2020 31DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 21DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220689
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1124
11241117 (USA/57/F)* Placebo Dose 2/60 14NOV2020 19NOV2020 Neg/Neg/Neg New or increased
shortness of breathPos/, 15NOV2020
C4591001 1124
11241128
(USA/67/M)* Placebo Dose 2/88 17DEC2020 Neg/Neg/Neg Fever Pos/, 18JAN2021
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1124
11241176
(USA/49/M)* Placebo Dose 2/72 03DEC2020 20DEC2020 Neg/Neg/Neg Fever Pos/, 04DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1125
11251006
(USA/35/M)* Placebo Dose 2/42 11OCT2020 12OCT2020 Neg/Neg/Neg Fever Pos/, 11OCT2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 106
FDA-CBER-2021-5683-0220690
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
cough
Chills
C4591001 1125
11251014 (USA/45/F)* Placebo Dose 2/59 30OCT2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Diarrhea
C4591001 1125
11251023
(USA/49/M)* Placebo Dose 2/56 27OCT2020 18NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 06NOV2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
C4591001 1125
11251028 (USA/39/F)* Placebo Dose 2/27 29SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos/, 01OCT2020
Chills
New or increased
muscle pain
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 107
FDA-CBER-2021-5683-0220691
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1125
11251038
(USA/28/M)* Placebo Dose 2/74 16NOV2020 Neg/Neg/Neg Diarrhea Pos/, 23NOV2020
C4591001 1125
11251049
(USA/52/M)* Placebo Dose 2/50 27OCT2020 24DEC2020 Neg/Neg/Neg New loss of taste or
smell Pos/, 02NOV2020
Sore throa t
C4591001 1125
11251088
(USA/67/M)* Placebo Dose 2/92 14DEC2020 10JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 23DEC2020
New or increased
shortness of breath
C4591001 1125
11251098 (USA/33/F)* Placebo Dose 2/78 02DEC2020 Neg/Neg/Neg New or increased
coughPos/, 03DEC2020
C4591001 1125
11251106 (USA/44/F)* Placebo Dose 2/68 20NOV2020 04DEC2020 Neg/Neg/Neg New or increased
coughPos/, 20NOV2020
Sore throa t
C4591001 1125
11251107 (USA/69/M) Placebo Dose 2/3 22OCT2020 19NOV2020 Neg/Neg/Neg Fever Pos/Pos, 28OCT2020
Chills
C4591001 1125
11251109 (USA/46/F)* Placebo Dose 2/51 04NOV2020 18NOV2020 Neg/Neg/Neg Fever Pos/, 05NOV2020
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220692
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1125
11251114
(USA/59/M)* Placebo Dose 2/38 22OCT2020 26OCT2020 Neg/Neg/Neg Fever Pos/Pos, 28OCT2020
C4591001 1125
11251124
(USA/39/M)* Placebo Dose 2/53 08NOV2020 10NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
Chills
New or increased
muscle pain
C4591001 1125
11251148 (USA/54/F) BNT162b2 (30
μg) Dose 1/13 14SEP2020 23SEP2020 Neg/Neg/Neg New loss of taste or
smellPos/, 16SEP2020
C4591001 1125
11251177 (USA/50/F)* BNT162b2 (30
μg) Dose 2/68 29NOV2020 13DEC2020 Neg/Neg/Neg New or increased
coughPos/, 03DEC2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1125
11251208 (USA/51/F)* Placebo Dose 2/43 13NOV2020 18NOV2020 Neg/Neg/Neg New or increased
coughPos/Pos, 19NOV2020
New loss of taste or
smell
C4591001 1125
11251215
(USA/43/M)* Placebo Dose 2/25 06NOV2020 13NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 11NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 109
FDA-CBER-2021-5683-0220693
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1125
11251218 (USA/41/F)* Placebo Dose 2/37 20NOV2020 04DEC2020 Neg/Neg/Neg Chills Pos/, 23NOV2020
New loss of taste or
smell
C4591001 1125
11251222 (USA/85/F) BNT162b2 (30
μg) Dose 1/6 02NOV2020 Neg/Neg/Neg New or increased
coughPos/, 05NOV2020
C4591001 1125
11251238 (USA/17/F) Placebo Dose 1/12 02NOV2020 13NOV2020 Neg/Neg/Pos New loss of taste or
smellPos/, 03NOV2020
C4591001 1126
11261017 (USA/34/F)* Placebo Dose 2/50 20OCT2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 21OCT2020
New or increased
muscle pain
C4591001 1126
11261179
(USA/60/M)* Placebo Dose 2/85 30DEC2020 28JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1126
11261287 (USA/15/M) Placebo Dose 1/15 30DEC2020 11JAN2021 Neg/Neg/Pos Fever Pos/, 04JAN2021
C4591001 1127
11271099 (USA/23/F) Placebo Dose 1/21 08SEP2020 16SEP2020 Neg/Neg/Pos New or increased
coughPos/, 10SEP2020
New or increased
shortness of breath
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 110
FDA-CBER-2021-5683-0220694
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New loss of taste or
smell
Sore throa t
C4591001 1128
11281156
(USA/53/M)* Placebo Dose 2/115 31DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Diarrhea
C4591001 1128
11281165 (USA/26/F)* Placebo Dose 2/46 29OCT2020 03NOV2020 Neg/Neg/Neg New or increased
coughPos/, 02NOV2020
Sore throa t
C4591001 1128
11281194
(USA/82/M)* Placebo Dose 2/112 05JAN2021 19JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 21JAN2021
Vomitin g
C4591001 1128
11281224
(USA/46/M)* Placebo Dose 2/88 14DEC2020 29DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 17DEC2020
New or increased
shortness of breath
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220695
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Sore throa t
C4591001 1128
11281281 (USA/36/F)* Placebo Dose 2/51 12NOV2020 13NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020
New or increased
muscle pain
Sore throa t
C4591001 1128
11281312
(USA/40/M)* Placebo Dose 2/66 04DEC2020 15JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 08DEC2020
New loss of taste or
smell
Sore throa t
C4591001 1128
11281375 (USA/57/F)* Placebo Dose 2/81 27DEC2020 29DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 28DEC2020
C4591001 1129
11291044 (USA/62/F)* Placebo Dose 2/92 24NOV2020 09DEC2020 Neg/Neg/Neg New or increased
coughPos/, 24NOV2020
New loss of taste or
smell
Diarrhea
C4591001 1131
11311036 (USA/62/F)* Placebo Dose 2/112 29DEC2020 13JAN2021 Neg/Neg/Neg Fever Pos/, 30DEC2020
New or increased
cough
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 112
FDA-CBER-2021-5683-0220696
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1131
11311039 (USA/69/F)* Placebo Dose 2/107 23DEC2020 26DEC2020 Neg/Neg/Neg New or increased
coughPos/, 28DEC2020
Diarrhea
C4591001 1131
11311045
(USA/40/M)* Placebo Dose 2/143 31JAN2021 07FEB2021 Neg/Neg/Neg Fever Pos/, 01FEB2021
New or increased
cough
Chills
Diarrhea
Vomitin g
C4591001 1131
11311100
(USA/64/M)* Placebo Dose 2/58 12NOV2020 30NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1131
11311113 (USA/40/F)* Placebo Dose 2/59 21NOV2020 23NOV2020 Neg/Neg/Neg New or increased
coughPos/, 23NOV2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 113
FDA-CBER-2021-5683-0220697
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
shortness of breath
C4591001 1131
11311138 (USA/45/F)* Placebo Dose 2/45 07NOV2020 01DEC2020 Neg/Neg/Neg New or increased
coughPos/, 10NOV2020
New or increased
shortness of breath
C4591001 1131
11311160 (USA/27/F)* Placebo Dose 2/52 18NOV2020 02DEC2020 Neg/Neg/Neg New or increased
coughPos/, 23NOV2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throa t
C4591001 1131
11311170 (USA/60/F)* BNT162b2 (30
μg) Dose 2/58 27NOV2020 22FEB2021 Neg/Neg/Neg New or increased
coughPos/, 29NOV2020
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1131
11311241
(USA/50/M)* Placebo Dose 2/63 03JAN2021 10JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 11JAN2021
New or increased
shortness of breath
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 114
FDA-CBER-2021-5683-0220698
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1131
11311269
(USA/16/M)* Placebo Dose 2/45 28JAN2021 04FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 28JAN2021
New or increased
shortness of breath
Chills
C4591001 1133
11331097 (USA/46/F)* Placebo Dose 2/143 18JAN2021 08FEB2021 Neg/Neg/Neg Fever Pos/, 02FEB2021
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
C4591001 1133
11331209
(USA/30/M)* Placebo Dose 2/32 10OCT2020 15OCT2020 Neg/Neg/Neg New or increased
cough Pos/, 13OCT2020
Sore throa t
C4591001 1133
11331333 (USA/46/F)* Placebo Dose 2/108 08JAN2021 09FEB2021 Neg/Neg/Neg New or increased
coughPos/, 18JAN2021
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220699
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1133
11331335
(USA/51/M)* Placebo Dose 2/108 08JAN2021 27JAN2021 Neg/Neg/Neg Fever Pos/, 18JAN2021
New or increased
cough
New or increased
muscle pain
C4591001 1133
11331445 (USA/61/F)* Placebo Dose 2/73 18DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 11JAN2021
Chills
New or increased
muscle pain
Diarrhea
C4591001 1133
11331511
(USA/30/M)* BNT162b2 (30
μg) Dose 2/50 02DEC2020 10DEC2020 Neg/Neg/Neg New or increased
shortness of breath Pos/, 07DEC2020
New loss of taste or
smell
C4591001 1133
11331525
(USA/45/M)* Placebo Dose 2/16 26NOV2020 27NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 01DEC2020
New or increased
muscle pain
C4591001 1133
11331526
(USA/55/M)* Placebo Dose 2/20 30NOV2020 16DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 01DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 116
FDA-CBER-2021-5683-0220700
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
C4591001 1133
11331562 (USA/31/F) Placebo Dose 1/20 14NOV2020 19NOV2020 Neg/Neg/Neg New loss of taste or
smellPos/, 16NOV2020
C4591001 1133
11331604
(USA/54/M)* Placebo Dose 2/19 07DEC2020 15DEC2020 Neg/Neg/Neg New loss of taste or
smell Pos/, 14DEC2020
C4591001 1134
11341022
(USA/66/M)* Placebo Dose 2/29 29SEP2020 03OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/, 30SEP2020
Sore throa t
C4591001 1134
11341031
(USA/31/M)* Placebo Dose 2/92 30NOV2020 05DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 01DEC2020
New loss of taste or
smell
C4591001 1134
11341035 (USA/59/F)* Placebo Dose 2/114 23DEC2020 06JAN2021 Neg/Neg/Neg Fever Pos/, 24DEC2020
New or increased
cough
Diarrhea
C4591001 1134
11341086 (USA/41/F)* Placebo Dose 2/134 19JAN2021 15FEB2021 Neg/Neg/Neg New or increased
coughPos/, 20JAN2021
C4591001 1134
11341174 (USA/36/F) BNT162b2 (30
μg) Dose 1/135 07JAN2021 12MAR2021 Neg/Neg/Neg New or increased
coughPos/, 08JAN2021
New or increased
shortness of breath
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220701
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Diarrhea
C4591001 1134
11341190 (USA/52/F)* Placebo Dose 2/94 19DEC2020 31DEC2020 Neg/Neg/Neg Fever Pos/, 20DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1134
11341254 (USA/29/F)* Placebo Dose 2/106 07JAN2021 03FEB2021 Neg/Neg/Neg New or increased
coughNeg/ (R1 Pos),
(19JAN2021)
New or increased
shortness of breath
Sore throa t
C4591001 1134
11341406
(USA/48/M)* Placebo Dose 2/43 14DEC2020 07JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020
New or increased
cough
New or increased
shortness of breath
Chills
C4591001 1134
11341411
(USA/69/M)* Placebo Dose 2/18 20NOV2020 21NOV2020 Neg/Neg/Neg Fever Pos/, 21NOV2020
C4591001 1135
11351001 (USA/18/M) Placebo Dose 2/83 15NOV2020 07DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 17NOV2020
New loss of taste or
smell
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 118
FDA-CBER-2021-5683-0220702
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1135
11351023 (USA/37/F) Placebo Dose 2/128 30DEC2020 06JAN2021 Neg/Neg/Neg New or increased
coughPos/, 02JAN2021
New or increased
shortness of breath
C4591001 1135
11351029
(USA/27/M)* Placebo Dose 2/84 18NOV2020 24NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 20NOV2020
C4591001 1135
11351038
(USA/48/M)* Placebo Dose 2/97 07DEC2020 15DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 08DEC2020
Chills
New or increased
muscle pain
C4591001 1135
11351041 (USA/29/F)* Placebo Dose 2/122 27DEC2020 22JAN2021 Neg/Neg/Neg New or increased
coughPos/, 29DEC2020
New or increased
shortness of breath
Diarrhea
C4591001 1135
11351045 (USA/57/F)* Placebo Dose 2/106 08DEC2020 22FEB2021 Neg/Neg/Neg New or increased
coughPos/, 10DEC2020
New loss of taste or
smell
C4591001 1135
11351082 (USA/39/F)* Placebo Dose 2/116 21DEC2020 08JAN2021 Neg/Neg/Neg New or increased
coughPos/, 24DEC2020
New or increased
shortness of breath
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 119
FDA-CBER-2021-5683-0220703
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Diarrhea
Vomitin g
C4591001 1135
11351111 (USA/53/F)* Placebo Dose 2/128 05JAN2021 12JAN2021 Neg/Neg/Neg New or increased
muscle painPos/, 06JAN2021
C4591001 1135
11351148 (USA/35/M) Placebo Dose 2/3 10SEP2020 20SEP2020 Neg/Neg/Neg Fever Pos/, 15SEP2020
New or increased
cough
New or increased
muscle pain
Sore throa t
C4591001 1135
11351177 (USA/46/F)* Placebo Dose 2/70 18NOV2020 28NOV2020 Neg/Neg/Neg Fever Pos/, 19NOV2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
Vomitin g
C4591001 1135
11351207 (USA/33/F)* Placebo Dose 2/30 13OCT2020 28OCT2020 Neg/Neg/Neg New or increased
muscle painPos/, 19OCT2020
New loss of taste or
smell
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 120
FDA-CBER-2021-5683-0220704
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1135
11351230
(USA/38/M)* Placebo Dose 2/48 15NOV2020 18NOV2020 Neg/Neg/Neg Fever Pos/, 17NOV2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1135
11351237 (USA/75/F)* Placebo Dose 2/99 28DEC2020 31DEC2020 Neg/Neg/Neg New or increased
coughPos/, 29DEC2020
C4591001 1135
11351294
(USA/42/M)* Placebo Dose 2/95 26DEC2020 29DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 29DEC2020
New or increased
muscle pain
C4591001 1135
11351361 (USA/24/F)* Placebo Dose 2/106 20JAN2021 28JAN2021 Neg/Neg/Neg New or increased
coughPos/, 25JAN2021
Chills
New or increased
muscle pain
Sore throa t
C4591001 1135
11351388 (USA/63/F)* Placebo Dose 2/65 12DEC2020 30DEC2020 Neg/Neg/Neg New or increased
coughPos/, 15DEC2020
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 121
FDA-CBER-2021-5683-0220705
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1135
11351390
(USA/60/M)* Placebo Dose 2/56 03DEC2020 15DEC2020 Neg/Neg/Neg Fever Pos/, 04DEC2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1135
11351400
(USA/37/M)* Placebo Dose 2/57 08DEC2020 01JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 11DEC2020
Chills
New or increased
muscle pain
New loss of taste or
smell
Vomitin g
C4591001 1135
11351426
(USA/57/M)* Placebo Dose 2/69 23DEC2020 02JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 02JAN2021
Chills
New loss of taste or
smell
C4591001 1135
11351451 (USA/50/F)* Placebo Dose 2/30 08DEC2020 21DEC2020 Neg/Neg/Neg New or increased
coughPos/, 09DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 122
FDA-CBER-2021-5683-0220706
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Chills
New or increased
muscle pain
C4591001 1135
11351527
(USA/43/M)* Placebo Dose 2/81 01FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 04FEB2021
C4591001 1135
11351534 (USA/37/F)* Placebo Dose 2/30 15DEC2020 11JAN2021 Neg/Neg/Neg New or increased
coughPos/, 21DEC2020
C4591001 1136
11361011
(USA/72/M)* Placebo Dose 2/62 18NOV2020 02DEC2020 Neg/Neg/Neg New or increased
muscle pain Pos/, 25NOV2020
C4591001 1136
11361012
(USA/39/M)* Placebo Dose 2/82 28NOV2020 21DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 30NOV2020
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
C4591001 1140
11401028 (USA/53/F)* Placebo Dose 2/91 09DEC2020 18DEC2020 Neg/Neg/Neg New or increased
coughPos/, 10DEC2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1140
11401039 (USA/53/F)* Placebo Dose 2/121 22DEC2020 03JAN2021 Neg/Neg/Neg New or increased
muscle painPos/, 25DEC2020
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 123
FDA-CBER-2021-5683-0220707
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1140
11401063
(USA/49/M)* BNT162b2 (30
μg) Dose 2/108 11DEC2020 23DEC2020 Neg/Neg/Neg Sore throat Pos/, 13DEC2020
C4591001 1140
11401135
(USA/54/M)* Placebo Dose 2/110 26DEC2020 29DEC2020 Neg/Neg/Neg Fever Pos/, 29DEC2020
Chills
New or increased
muscle pain
Sore throa t
C4591001 1140
11401263 (USA/66/F)* Placebo Dose 2/67 31DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/, 02JAN2021
Sore throa t
C4591001 1140
11401281
(USA/23/M)* Placebo Dose 2/65 05JAN2021 31JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021
New or increased
cough
Chills
Sore throa t
C4591001 1141
11411006 (USA/25/M) BNT162b2 (30
μg) Dose 2/119 17DEC2020 19DEC2020 Pos/Neg/Neg New or increased
coughPos/, 20DEC2020
New or increased
shortness of breath
Chills
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220708
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1141
11411020 (USA/29/M) Placebo Dose 2/6 29AUG2020 04SEP2020 Neg/Neg/Neg New or increased
coughPos/, 30AUG2020
New or increased
muscle pain
Sore throa t
C4591001 1141
11411032 (USA/22/F)* Placebo Dose 2/72 20NOV2020 29NOV2020 Neg/Neg/Neg New loss of taste or
smellPos/, 24NOV2020
Sore throa t
C4591001 1141
11411045 (USA/46/F)* Placebo Dose 2/81 16NOV2020 05JAN2021 Neg/Neg/Neg Fever Neg/ (R1 Pos),
(20DEC2020)
New or increased
cough
Chills
New loss of taste or
smell
Sore throa t
C4591001 1141
11411088
(USA/52/M)* Placebo Dose 2/29 07OCT2020 10OCT2020 Neg/Neg/Neg Fever Pos/, 08OCT2020
Chills
Sore throa t
C4591001 1141
11411161 (USA/25/F)* Placebo Dose 2/47 08NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020
New or increased
cough
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 125
FDA-CBER-2021-5683-0220709
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Diarrhea
Vomitin g
C4591001 1141
11411162
(USA/20/M)* Placebo Dose 2/44 05NOV2020 09NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 08NOV2020
Sore throa t
C4591001 1141
11411175 (USA/28/F)* Placebo Dose 2/51 14NOV2020 30NOV2020 Neg/Neg/Neg New or increased
coughPos/, 17NOV2020
Chills
New or increased
muscle pain
C4591001 1141
11411195 (USA/36/F)* Placebo Dose 2/94 15JAN2021 Neg/Neg/Neg Fever Pos/ (R1 Pos),
26JAN2021
(03FEB2021)
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
Diarrhea
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 126
FDA-CBER-2021-5683-0220710
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1141
11411204 (USA/21/F)* Placebo Dose 2/61 30NOV2020 13DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1141
11411221 (USA/46/F)* Placebo Dose 2/76 21DEC2020 02JAN2021 Neg/Neg/Neg Fever Pos/, 22DEC2020
Chills
New or increased
muscle pain
C4591001 1141
11411242 (USA/22/F)* Placebo Dose 2/25 08NOV2020 30NOV2020 Neg/Neg/Neg New or increased
coughPos/, 20NOV2020
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 1142
11421120
(USA/68/M)* Placebo Dose 2/96 12DEC2020 31DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 15DEC2020
New or increased
muscle pain
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 127
FDA-CBER-2021-5683-0220711
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1142
11421148
(USA/59/M)* Placebo Dose 2/59 11NOV2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1142
11421197 (USA/48/F) Placebo Dose 2/70 08DEC2020 14DEC2020 Neg/Neg/Neg Fever Pos/, 09DEC2020
New or increased
shortness of breath
Chills
C4591001 1142
11421255
(USA/48/M)* Placebo Dose 2/68 20DEC2020 10JAN2021 Neg/Neg/Neg New or increased
shortness of breath Pos/, 23DEC2020
New or increased
muscle pain
C4591001 1142
11421388
(USA/15/M)* Placebo Dose 2/25 19FEB2021 Neg/Neg/Neg Sore throat Pos/, 19FEB2021
C4591001 1145
11451056 (USA/67/F)* Placebo Dose 2/59 14NOV2020 20NOV2020 Neg/Neg/Neg New or increased
muscle painPos/, 16NOV2020
C4591001 1146
11461004 (USA/40/F)* Placebo Dose 2/84 24NOV2020 28DEC2020 Neg/Neg/Neg New or increased
coughPos/, 27NOV2020
New loss of taste or
smell
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 128
FDA-CBER-2021-5683-0220712
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1146
11461070 (USA/54/F)* Placebo Dose 2/116 03JAN2021 08JAN2021 Neg/Neg/Neg New or increased
coughPos/, 07JAN2021
New loss of taste or
smell
Diarrhea
C4591001 1146
11461071
(USA/54/M)* BNT162b2 (30
μg) Dose 2/116 03JAN2021 08JAN2021 Neg/Neg/Neg Sore throat Pos/, 11JAN2021
C4591001 1146
11461156
(USA/60/M)* Placebo Dose 2/54 09NOV2020 23NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020
New or increased
cough
New or increased
muscle pain
C4591001 1146
11461235
(USA/65/M)* Placebo Dose 2/60 03DEC2020 08DEC2020 Neg/Neg/Neg New or increased
cough Unk/Pos, 03DEC2020
New or increased
muscle pain
C4591001 1146
11461268
(USA/42/M)* Placebo Dose 2/73 20JAN2021 27JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 21JAN2021
Sore throa t
C4591001 1146
11461309 (USA/52/F)* Placebo Dose 2/17 28NOV2020 02DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 28NOV2020
Sore throa t
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 129
FDA-CBER-2021-5683-0220713
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1146
11461379
(USA/45/M)* Placebo Dose 2/17 03DEC2020 Neg/Neg/Neg Sore throat Pos/, 05DEC2020
Diarrhea
C4591001 1147
11471004 (USA/62/M) Placebo Dose 1/22 24AUG2020 28AUG2020 Neg/Neg/Un k New or increased
coughPos/, 26AUG2020
Sore throa t
C4591001 1147
11471021 (USA/35/F)* Placebo Dose 2/108 13DEC2020 20DEC2020 Neg/Neg/Neg New loss of taste or
smellPos/Pos, 24DEC2020
C4591001 1147
11471025
(USA/35/M)* Placebo Dose 2/101 04DEC2020 18DEC2020 Neg/Neg/Neg Fever Pos/, 05DEC2020
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1147
11471035 (USA/52/M) Placebo Dose 1/18 23AUG2020 11SEP2020 Neg/Neg/Un k New or increased
coughPos/Pos, 24AUG2020
Chills
Sore throa t
C4591001 1147
11471176
(USA/20/M)* Placebo Dose 2/106 23DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 26DEC2020
New or increased
cough
Chills
090177e196af7327\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0220714
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1147
11471205
(USA/57/M)* Placebo Dose 2/79 08DEC2020 11DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 09DEC2020
C4591001 1147
11471228 (USA/59/F)* BNT162b2 (30
μg) Dose 2/74 11DEC2020 18DEC2020 Neg/Neg/Neg Sore throat Pos/, 13DEC2020
C4591001 1147
11471280 (USA/12/M) Placebo Dose 1/6 09JAN2021 12JAN2021 Neg/Neg/Un k Fever Pos/, 10JAN2021
Chills
C4591001 1149
11491066 (USA/40/M) Placebo Dose 1/13 24AUG2020 04SEP2020 Neg/Neg/Neg Fever Pos/, 30AUG2020
New or increased
cough
C4591001 1149
11491113
(USA/69/M)* BNT162b2 (30
μg) Dose 2/44 23OCT2020 24OCT2020 Neg/Neg/Neg Fever Pos/, 26OCT2020
Chills
Vomitin g
C4591001 1149
11491135
(USA/71/M)* Placebo Dose 2/76 28NOV2020 23JAN2021 Neg/Neg/Neg Fever Pos/, 01DEC2020
New or increased
cough
Chills
New or increased
muscle pain
Sore throa t
Diarrhea
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FDA-CBER-2021-5683-0220715
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1149
11491160 (USA/34/F)* Placebo Dose 2/112 06JAN2021 22JAN2021 Neg/Neg/Neg New or increased
coughPos/, 08JAN2021
Chills
New or increased
muscle pain
Sore throa t
C4591001 1149
11491260
(USA/60/M)* Placebo Dose 2/77 24DEC2020 01JAN2021 Neg/Neg/Neg New or increased
shortness of breath Pos/, 04JAN2021
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1149
11491263 (USA/24/F)* BNT162b2 (30
μg) Dose 2/96 12JAN2021 26JAN2021 Neg/Neg/Neg New or increased
muscle painPos/, 14JAN2021
Sore throa t
Diarrhea
C4591001 1149
11491265
(USA/59/M)* Placebo Dose 2/107 26JAN2021 13FEB2021 Neg/Neg/Neg Fever Pos/, 03FEB2021
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
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FDA-CBER-2021-5683-0220716
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1149
11491340 (USA/47/F)* Placebo Dose 2/30 18DEC2020 20DEC2020 Neg/Neg/Neg New or increased
muscle painPos/, 19DEC2020
New loss of taste or
smell
C4591001 1150
11501009
(USA/29/M)* Placebo Dose 2/123 09JAN2021 17JAN2021 Neg/Neg/Neg New or increased
cough Pos/, 11JAN2021
New loss of taste or
smell
C4591001 1150
11501055 (USA/42/F)* Placebo Dose 2/107 30DEC2020 08JAN2021 Neg/Neg/Neg New or increased
coughPos/, 30DEC2020
Sore throa t
C4591001 1150
11501093 (USA/45/F)* Placebo Dose 2/84 16DEC2020 09JAN2021 Neg/Neg/Neg New loss of taste or
smellPos/, 28DEC2020
C4591001 1150
11501204
(USA/14/M)* Placebo Dose 2/32 04FEB2021 Neg/Neg/Neg New or increased
cough Pos/, 05FEB2021
Sore throa t
C4591001 1150
11501291 (USA/15/M) Placebo Dose 1/2 12JAN2021 26JAN2021 Neg/Neg/Neg New or increased
coughPos/, 13JAN2021
Sore throa t
C4591001 1152
11521010 (USA/34/F)* Placebo Dose 2/87 27NOV2020 27DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020
New or increased
shortness of breath
New loss of taste or
smell
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FDA-CBER-2021-5683-0220717
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1152
11521032 (USA/22/F)* Placebo Dose 2/113 22DEC2020 16JAN2021 Neg/Neg/Neg New or increased
coughPos/, 28DEC2020
New or increased
muscle pain
New loss of taste or
smell
C4591001 1152
11521039 (USA/39/F)* Placebo Dose 2/93 03DEC2020 20DEC2020 Neg/Neg/Neg New or increased
coughPos/, 15DEC2020
New or increased
shortness of breath
New loss of taste or
smell
C4591001 1152
11521063 (USA/35/F)* Placebo Dose 2/117 26DEC2020 10JAN2021 Neg/Neg/Neg New or increased
coughPos/, 06JAN2021
New loss of taste or
smell
C4591001 1152
11521082 (USA/62/F)* Placebo Dose 2/115 25DEC2020 20JAN2021 Neg/Neg/Neg New or increased
coughUnk/Pos, 07JAN2021
Diarrhea
C4591001 1152
11521226
(USA/47/M)* Placebo Dose 2/68 21NOV2020 10DEC2020 Neg/Neg/Neg New or increased
cough Pos/, 24NOV2020
Chills
New or increased
muscle pain
New loss of taste or
smell
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FDA-CBER-2021-5683-0220718
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1152
11521265
(USA/77/M)* BNT162b2 (30
μg) Dose 2/53 12NOV2020 30NOV2020 Neg/Neg/Neg New or increased
cough Pos/, 24NOV2020
C4591001 1152
11521309 (USA/31/F)* Placebo Dose 2/69 29NOV2020 15DEC2020 Neg/Neg/Neg New or increased
shortness of breathPos/, 30NOV2020
Chills
Sore throa t
Diarrhea
C4591001 1152
11521322
(USA/20/M)* Placebo Dose 2/109 08JAN2021 22JAN2021 Neg/Neg/Neg New loss of taste or
smell Pos/, 12JAN2021
Sore throa t
C4591001 1152
11521339
(USA/35/M)* Placebo Dose 2/64 26NOV2020 12DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020
New or increased
muscle pain
New loss of taste or
smell
Sore throa t
C4591001 1152
11521342 (USA/57/F)* Placebo Dose 2/98 28DEC2020 Neg/Neg/Neg New or increased
coughPos/, 06JAN2021
Sore throa t
C4591001 1152
11521363
(USA/19/M)* Placebo Dose 2/9 06OCT2020 10OCT2020 Neg/Neg/Neg New or increased
cough Pos/, 07OCT2020
C4591001 1152
11521372 (USA/28/F)* Placebo Dose 2/32 29OCT2020 07NOV2020 Neg/Neg/Neg New or increased
coughPos/, 31OCT2020
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FDA-CBER-2021-5683-0220719
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
Chills
New or increased
muscle pain
Sore throa t
C4591001 1152
11521413 (USA/27/F)* Placebo Dose 2/105 11JAN2021 Neg/Neg/Neg Fever Pos/, 14JAN2021
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 1152
11521455 (USA/53/F)* Placebo Dose 2/83 28DEC2020 13JAN2021 Neg/Neg/Neg New or increased
muscle painPos/, 14JAN2021
New loss of taste or
smell
C4591001 1152
11521473
(USA/60/M)* Placebo Dose 2/76 28DEC2020 19FEB2021 Neg/Neg/Neg Chills Pos/, 13JAN2021
New loss of taste or
smell
Sore throa t
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FDA-CBER-2021-5683-0220720
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1152
11521501 (USA/27/F)* Placebo Dose 2/13 10NOV2020 12NOV2020 Neg/Neg/Neg New or increased
coughPos/, 16NOV2020
C4591001 1152
11521573 (USA/59/F)* Placebo Dose 2/48 03JAN2021 Neg/Neg/Neg New or increased
coughPos/, 06JAN2021
Chills
New or increased
muscle pain
Diarrhea
C4591001 1152
11521666 (USA/15/F)* Placebo Dose 2/17 15JAN2021 23JAN2021 Neg/Neg/Neg New or increased
coughPos/, 21JAN2021
New or increased
muscle pain
New loss of taste or
smell
C4591001 1156
11561006 (USA/45/M) BNT162b2 (30
μg) Dose 1/11 30AUG2020 01SEP2020 Neg/Pos/Neg New or increased
coughPos/Pos, 02SEP2020
C4591001 1156
11561033 (USA/55/F) Placebo Dose 1/11 05SEP2020 26SEP2020 Neg/Neg/Pos New or increased
coughPos/, 08SEP2020
New loss of taste or
smell
C4591001 1156
11561044 (USA/63/M) Placebo Dose 1/6 01SEP2020 29SEP2020 Neg/Neg/Neg Fever Pos/, 03SEP2020
New or increased
cough
New or increased
shortness of breath
Chills
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16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 –
Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb),
Swab Da
…[truncated]