125742 S1 M5 5351 c4591001 fa interim lab measurements sensitive
Document text
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1003
10031122
(USA/48/M)* Placebo Dose 2/77 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1005
10051341 (USA/23/F) Placebo Dose 1/2 22OCT2020 Neg/Pos/Neg New or increased
cough Pos/
New or increased
shortness of breath
New loss of taste
or smell
Sore throat
Diarrhea
C4591001 1005
10051403 (USA/66/F) BNT162b2 (30
μg) Dose 1/4 07NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Sore throat
C4591001 1006
10061012
(USA/53/M)* Placebo Dose 2/68 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1006
10061066 (USA/39/F)* Placebo Dose 2/59 11NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 1
FDA-CBER-2021-5683-0020181
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1006
10061084 (USA/27/F)* Placebo Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1006
10061091 (USA/20/F)* Placebo Dose 2/50 30OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1006
10061114
(USA/21/M)* Placebo Dose 2/35 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1007
10071407 (USA/41/M) Placebo Dose 1/12 02NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Sore throat
Diarrhea
C4591001 1007
10071409 (USA/13/M) BNT162b2 (30
μg) Dose 1/10 31OCT2020 04NOV2020 Neg/Neg/Unk Fever Pos/
C4591001 1008
10081011 (USA/55/F)* Placebo Dose 2/52 22OCT2020 31OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1008
10081048 (USA/38/F)* Placebo Dose 2/60 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 2
FDA-CBER-2021-5683-0020182
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1008
10081130 (USA/52/F)* Placebo Dose 2/32 17OCT2020 29OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
C4591001 1008
10081214
(USA/62/M)* Placebo Dose 2/42 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1008
10081319 (USA/79/F)* Placebo Dose 2/31 04NOV2020 Neg/Neg/Neg Chills Pos/
C4591001 1008
10081338 (USA/53/M) Placebo Dose 2/1 06OCT2020 16OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 3
FDA-CBER-2021-5683-0020183
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1008
10081356
(USA/63/M)* Placebo Dose 2/25 31OCT2020 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
C4591001 1008
10081529 (USA/38/M) BNT162b2 (30
μg) Dose 1/2 26SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste
or smell
Sore throat
C4591001 1008
10081580 (USA/38/M) Placebo Dose 2/7 03NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste
or smell
C4591001 1008
10081639 (USA/63/M) Placebo Dose 1/6 24OCT2020 Neg/Neg/Unk New or increased
cough Pos/
Sore throat
C4591001 1008
10081721 (USA/37/F) Placebo Dose 1/13 10NOV2020 Neg/Neg/Unk Sore throat Pos/
C4591001 1009
10091128
(USA/51/M)* Placebo Dose 2/30 15OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 4
FDA-CBER-2021-5683-0020184
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
Sore throat
C4591001 1009
10091211 (USA/44/F) Placebo Dose 1/19 03NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Chills
Sore throat
C4591001 1009
10091257 (USA/21/F) Placebo Dose 1/10 05NOV2020 Neg/Neg/Unk New or increased
cough Pos/
New or increased
shortness of breath
Chills
C4591001 1011
10111174 (USA/24/M) Placebo Dose 2/7 04NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
Sore throat
C4591001 1013
10131288
(USA/53/M)* Placebo Dose 2/11 25SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 5
FDA-CBER-2021-5683-0020185
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste
or smell
C4591001 1013
10131475 (USA/49/F)* Placebo Dose 2/23 22OCT2020 25OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1013
10131670
(USA/41/M)† BNT162b2 (30
μg) Dose 1/4 11OCT2020 Neg/Pos/Neg New loss of taste
or smell Pos/
C4591001 1016
10161003 (USA/23/F)* Placebo Dose 2/57 14OCT2020 Neg/Neg/Neg Fever Pos/
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 smell Pos/
Sore throat
C4591001 1016
10161017 (USA/18/F)* Placebo Dose 2/19 07SEP2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 6
FDA-CBER-2021-5683-0020186
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
C4591001 1016
10161035 (USA/70/F)* Placebo Dose 2/67 29OCT2020 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1016
10161048 (USA/52/F)* Placebo Dose 2/75 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1016
10161183 (USA/31/F)* Placebo Dose 2/32 16OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/ (R1 Pos)
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
Diarrhea
Vomiting
C4591001 1016
10161207 (USA/62/F)* Placebo Dose 2/27 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 7
FDA-CBER-2021-5683-0020187
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1016
10161305 (USA/16/M) Placebo Dose 2/8 09NOV2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste
or smell
C4591001 1016
10161316 (USA/15/M) Placebo Dose 1/17 01NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
Diarrhea
C4591001 1016
10161319 (USA/12/F) Placebo Dose 2/6 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New loss of taste
or smell
Sore throat
C4591001 1016
10161341 (USA/44/F) BNT162b2 (30
μg) Dose 1/10 31OCT2020 Neg/Neg/Pos New or increased
cough Pos/
New or increased
shortness of breath
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 8
FDA-CBER-2021-5683-0020188
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
Diarrhea
C4591001 1018
10181198 (USA/50/F)* Placebo Dose 2/55 04NOV2020 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1019
10191038 (USA/47/F)* Placebo Dose 2/61 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste
or smell
C4591001 1019
10191184
(USA/52/M)* Placebo Dose 2/36 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Vomiting
C4591001 1024
10241130
(USA/65/M)† Placebo Dose 1/9 28OCT2020 Neg/Neg/Pos Fever Pos/
New or increased
muscle pain
C4591001 1028
10281038 (USA/53/F)* Placebo Dose 2/31 10OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 9
FDA-CBER-2021-5683-0020189
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1028
10281100 (USA/47/F)* Placebo Dose 2/19 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1028
10281132
(USA/61/M)* Placebo Dose 2/14 11OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1028
10281138 (USA/38/F)* Placebo Dose 2/25 23OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Sore throat
Diarrhea
C4591001 1028
10281193 (USA/60/F) Placebo Dose 2/7 14OCT2020 09NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1028
10281229 (USA/45/M) Placebo Dose 2/3 17OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New loss of taste
or smell
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 10
FDA-CBER-2021-5683-0020190
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Vomiting
C4591001 1028
10281250 (USA/18/M) Placebo Dose 1/11 18OCT2020 Neg/Neg/Pos Sore throat Pos/
C4591001 1028
10281294 (USA/23/F) Placebo Dose 1/7 04NOV2020 Neg/Neg/Unk New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1036
10361078 (USA/20/M) Placebo Dose 2/2 01OCT2020 Neg/Neg/Pos New loss of taste
or smell Pos/
C4591001 1037
10371036
(USA/62/M)* Placebo Dose 2/52 31OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1037
10371280
(USA/58/M)* Placebo Dose 2/28 10NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 11
FDA-CBER-2021-5683-0020191
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1038
10381051
(USA/69/M)* Placebo Dose 2/51 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1038
10381103 (USA/43/F) Placebo Dose 2/5 04OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1039
10391021 (USA/26/F) Placebo Dose 1/1 25AUG2020 14SEP2020 Neg/Pos/Pos Fever Pos/
New or increased
cough
New or increased
shortness of breath
New loss of taste
or smell
Sore throat
C4591001 1039
10391025 (USA/55/F)* Placebo Dose 2/40 25OCT2020 03NOV2020 Neg/Neg/Neg New loss of taste
or smell Pos/
Sore throat
C4591001 1046
10461058 (USA/44/F)* Placebo Dose 2/62 09NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1047
10471024 (USA/63/F)* BNT162b2 (30
μg) Dose 2/37 16OCT2020 18OCT2020 Neg/Neg/Neg Fever Pos/
Diarrhea
Vomiting
C4591001 1047
10471252 (USA/63/M) Placebo Dose 1/22 12OCT2020 Neg/Neg/Unk Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 12
FDA-CBER-2021-5683-0020192
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1068
10681033 (USA/65/M) Placebo Dose 1/23 15SEP2020 21OCT2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Diarrhea
C4591001 1068
10681082
(USA/58/M)* Placebo Dose 2/42 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Sore throat
C4591001 1068
10681110 (USA/30/F)* Placebo Dose 2/22 16OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 13
FDA-CBER-2021-5683-0020193
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1071
10711022
(USA/47/M)* Placebo Dose 2/72 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1071
10711058 (USA/72/F)* Placebo Dose 2/60 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1071
10711216 (USA/64/F) Placebo Dose 1/4 12OCT2020 17OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1071
10711228 (USA/66/F) BNT162b2 (30
μg) Dose 2/5 09NOV2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
C4591001 1072
10721051 (USA/47/F) Placebo Dose 1/12 06SEP2020 20SEP2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 14
FDA-CBER-2021-5683-0020194
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
Sore throat
C4591001 1072
10721057
(USA/70/M)* Placebo Dose 2/41 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1077
10771195 (USA/73/F)* Placebo Dose 2/40 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1079
10791046 (USA/55/F)* Placebo Dose 2/62 26OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1079
10791054 (USA/28/F)* Placebo Dose 2/63 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1079
10791162 (USA/20/M) Placebo Dose 2/45 09OCT2020 Neg/Neg/Neg Fever Pos/
Sore throat
C4591001 1081
10811151 (USA/79/F)* Placebo Dose 2/10 30SEP2020 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1082
10821016 (USA/46/F)* Placebo Dose 2/44 06OCT2020 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 15
FDA-CBER-2021-5683-0020195
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste
or smell
C4591001 1083
10831029 (USA/50/M) Placebo Dose 1/96 07NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Chills
C4591001 1085
10851286 (USA/52/F) Placebo Dose 1/24 02OCT2020 13OCT2020 Neg/Neg/Pos Sore throat Pos/
C4591001 1085
10851293 (USA/63/F)* Placebo Dose 2/37 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste
or smell
C4591001 1087
10871089 (USA/21/F) Placebo Dose 1/19 04SEP2020 30SEP2020 Neg/Neg/Unk Fever Pos/
C4591001 1087
10871209 (USA/50/F) BNT162b2 (30
μg) Dose 1/7 31AUG2020 03SEP2020 Neg/Neg/Unk Fever Pos/
New or increased
muscle pain
New loss of taste
or smell
C4591001 1088
10881219
(USA/63/M)* Placebo Dose 2/17 25OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 16
FDA-CBER-2021-5683-0020196
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
muscle pain
C4591001 1088
10881233
(USA/47/M)* Placebo Dose 2/15 02NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
Sore throat
C4591001 1089
10891217 (USA/64/F) BNT162b2 (30
μg) Dose 1/5 04SEP2020 12SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New or increased
shortness of breath
C4591001 1089
10891235 (USA/29/F)* Placebo Dose 2/47 08NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1090
10901121 (USA/58/F)* Placebo Dose 2/49 18OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/
New loss of taste
or smell
C4591001 1090
10901353
(USA/63/M)* Placebo Dose 2/40 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 17
FDA-CBER-2021-5683-0020197
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1091
10911014 (USA/52/M) Placebo Dose 2/76 03NOV2020 Neg/Neg/Neg Fever Pos/
Chills
Diarrhea
C4591001 1091
10911203
(USA/43/M)* Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Unk/Pos
New or increased
muscle pain
C4591001 1091
10911387 (USA/17/F) BNT162b2 (30
μg) Dose 1/2 06NOV2020 Unk/Neg/Unk Fever Pos/
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1092
10921021 (USA/60/F)* Placebo Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1092
10921130
(USA/53/M)* Placebo Dose 2/18 09OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 18
FDA-CBER-2021-5683-0020198
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
shortness of breath
New loss of taste
or smell
Sore throat
Diarrhea
C4591001 1092
10921158 (USA/23/M) Placebo Dose 1/10 12SEP2020 21SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste
or smell
Sore throat
C4591001 1092
10921268 (USA/64/F) BNT162b2 (30
μg) Dose 1/2 23OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/
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 breath Pos/
Chills
New or increased
muscle pain
C4591001 1093
10931050 (USA/62/M) Placebo Dose 1/24 16SEP2020 10NOV2020 Neg/Neg/Unk New or increased
cough Pos/
New loss of taste
or smell
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 19
FDA-CBER-2021-5683-0020199
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1093
10931081 (USA/67/F)* Placebo Dose 2/19 05OCT2020 19OCT2020 Neg/Neg/Neg Sore throat Pos/
C4591001 1093
10931148 (USA/21/F) Placebo Dose 2/1 12OCT2020 Neg/Neg/Pos New loss of taste
or smell Pos/
Diarrhea
C4591001 1095
10951238 (USA/63/F)* Placebo Dose 2/19 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1095
10951260
(USA/25/M)* Placebo Dose 2/9 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1096
10961172
(USA/51/M)* Placebo Dose 2/49 06NOV2020 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 20
FDA-CBER-2021-5683-0020200
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1096
10961258 (USA/55/F)* Placebo Dose 2/25 22OCT2020 Neg/Neg/Neg New or increased
cough Pos/Pos
New or increased
muscle pain
Sore throat
C4591001 1096
10961388 (USA/17/F) Placebo Dose 1/4 12OCT2020 15OCT2020 Neg/Neg/Pos Sore throat Pos/
C4591001 1097
10971103 (USA/72/F) Placebo Dose 1/18 25SEP2020 03OCT2020 Neg/Neg/Pos Fever Pos/
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/
New or increased
cough
New loss of taste
or smell
C4591001 1098
10981029 (USA/36/M) BNT162b2 (30
μg) Dose 1/11 31AUG2020 01SEP2020 Neg/Neg/Unk Fever Pos/
C4591001 1098
10981062 (USA/63/F)* Placebo Dose 2/32 17OCT2020 20OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 21
FDA-CBER-2021-5683-0020201
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1101
11011024 (USA/54/F) Placebo Dose 1/11 19SEP2020 07OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1101
11011095
(USA/60/M)* Placebo Dose 2/20 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1107
11071171
(USA/39/M)* Placebo Dose 2/58 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
C4591001 1109
11091067
(USA/42/M)* Placebo Dose 2/84 11NOV2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
Sore throat
C4591001 1109
11091092
(USA/18/M)* Placebo Dose 2/70 31OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1109
11091323
(USA/64/M)* Placebo Dose 2/47 31OCT2020 02NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 22
FDA-CBER-2021-5683-0020202
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
C4591001 1109
11091416 (USA/46/F)* Placebo Dose 2/41 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1109
11091448 (USA/46/F)* Placebo Dose 2/9 06OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/ (R1 Pos)
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1109
11091482
(USA/63/M)* Placebo Dose 2/28 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
C4591001 1109
11091556 (USA/41/M) Placebo Dose 1/8 11OCT2020 16OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1110
11101006 (USA/34/F) BNT162b2 (30
μg) Dose 1/2 01AUG2020 16AUG2020 Neg/Neg/Pos New or increased
cough Pos/
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 23
FDA-CBER-2021-5683-0020203
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
Vomiting
C4591001 1110
11101050
(USA/47/M)* BNT162b2 (30
μg) Dose 2/76 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Sore throat
C4591001 1110
11101072 (USA/42/M) Placebo Dose 2/4 28SEP2020 Neg/Neg/Pos New loss of taste
or smell Pos/
Sore throat
Diarrhea
C4591001 1110
11101136
(USA/62/M)* Placebo Dose 2/52 04NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Diarrhea
C4591001 1110
11101162
(USA/51/M)* BNT162b2 (30
μg) Dose 2/34 24OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
C4591001 1111
11111010
(USA/75/M)* Placebo Dose 2/45 04OCT2020 05OCT2020 Neg/Neg/Neg Fever Pos/
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 24
FDA-CBER-2021-5683-0020204
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1116
11161075
(USA/73/M)* Placebo Dose 2/43 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
C4591001 1116
11161253 (USA/61/M) Placebo Dose 1/8 25SEP2020 06OCT2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1116
11161322 (USA/23/M) Placebo Dose 2/7 20OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1117
11171010 (USA/72/F)* Placebo Dose 2/34 11OCT2020 19OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 25
FDA-CBER-2021-5683-0020205
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1118
11181088
(USA/73/M)* Placebo Dose 2/36 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
C4591001 1120
11201115 (USA/19/F)* Placebo Dose 2/73 06NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1120
11201335 (USA/63/F) Placebo Dose 1/8 23OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Diarrhea
C4591001 1121
11211105 (USA/52/M) Placebo Dose 2/39 05NOV2020 Neg/Unk/Neg Fever Pos/
New or increased
cough
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 26
FDA-CBER-2021-5683-0020206
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1122
11221025
(USA/40/M)* Placebo Dose 2/32 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1123
11231025 (USA/60/F) Placebo Dose 2/77 08NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Sore throat
C4591001 1123
11231073 (USA/25/F)* Placebo Dose 2/10 10SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/Pos
Chills
New or increased
muscle pain
Sore throat
C4591001 1123
11231085 (USA/20/M) Placebo Dose 1/4 16AUG2020 27AUG2020 Neg/Neg/Pos New or increased
muscle pain Pos/
C4591001 1123
11231086 (USA/35/F)* Placebo Dose 2/57 27OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
C4591001 1123
11231117 (USA/55/F)* Placebo Dose 2/64 10NOV2020 Neg/Neg/Neg Chills Pos/
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 27
FDA-CBER-2021-5683-0020207
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1123
11231144 (USA/53/F) BNT162b2 (30
μg) Dose 1/9 28AUG2020 19SEP2020 Neg/Unk/Unk Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
C4591001 1123
11231214 (USA/60/F)* Placebo Dose 2/34 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New loss of taste
or smell
Sore throat
C4591001 1123
11231234 (USA/29/M) Placebo Dose 2/32 02NOV2020 Unk/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1123
11231255
(USA/76/M)* Placebo Dose 2/20 24OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 28
FDA-CBER-2021-5683-0020208
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1123
11231256 (USA/72/F)* Placebo Dose 2/24 28OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1123
11231284
(USA/67/M)* Placebo Dose 2/12 24OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1123
11231313 (USA/42/F) Placebo Dose 1/13 06OCT2020 Neg/Neg/Pos Fever Pos/
Chills
New or increased
muscle pain
C4591001 1123
11231386 (USA/33/F) BNT162b2 (30
μg) Dose 1/8 26OCT2020 03NOV2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 29
FDA-CBER-2021-5683-0020209
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1125
11251006
(USA/35/M)* Placebo Dose 2/42 11OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1125
11251014 (USA/45/F)* Placebo Dose 2/59 30OCT2020 Neg/Neg/Neg Fever Pos/
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 Neg/Neg/Neg New or increased
cough Pos/
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/
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 30
FDA-CBER-2021-5683-0020210
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
Sore throat
C4591001 1125
11251049
(USA/52/M)* Placebo Dose 2/50 27OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
Sore throat
C4591001 1125
11251107 (USA/69/M) Placebo Dose 2/3 22OCT2020 Neg/Neg/Neg Fever Pos/
Chills
C4591001 1125
11251109 (USA/46/F)* Placebo Dose 2/51 04NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1125
11251114
(USA/59/M)* Placebo Dose 2/38 22OCT2020 Neg/Neg/Neg Fever Pos/Pos
C4591001 1125
11251124
(USA/39/M)* Placebo Dose 2/53 08NOV2020 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 31
FDA-CBER-2021-5683-0020211
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1125
11251148 (USA/54/F) BNT162b2 (30
μg) Dose 1/13 14SEP2020 23SEP2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1125
11251215
(USA/43/M)* Placebo Dose 2/25 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1125
11251222 (USA/85/F) BNT162b2 (30
μg) Dose 1/6 02NOV2020 Neg/Neg/Unk New or increased
coug h Pos/
C4591001 1125
11251238 (USA/17/F) Placebo Dose 1/12 02NOV2020 Neg/Neg/Unk New loss of taste
or smell Pos/
C4591001 1126
11261017 (USA/34/F)* Placebo Dose 2/50 20OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1127
11271099 (USA/23/F) Placebo Dose 1/21 08SEP2020 16SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New or increased
shortness of breath
Chills
New loss of taste
or smell
Sore throat
C4591001 1128
11281165 (USA/26/F)* Placebo Dose 2/46 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1131
11311100
(USA/64/M)* Placebo Dose 2/58 12NOV2020 Neg/Neg/Neg Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 32
FDA-CBER-2021-5683-0020212
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
New loss of taste
or smell
C4591001 1131
11311138 (USA/45/F)* Placebo Dose 2/45 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
C4591001 1133
11331209
(USA/30/M)* Placebo Dose 2/32 10OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1133
11331512 (USA/36/M) Placebo Dose 1/17 11OCT2020 Neg/Neg/Unk Fever Pos/
New loss of taste
or smell
C4591001 1134
11341022
(USA/66/M)* Placebo Dose 2/29 29SEP2020 03OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1135
11351148 (USA/35/M) Placebo Dose 2/3 10SEP2020 20SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 33
FDA-CBER-2021-5683-0020213
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1135
11351207 (USA/33/F)* Placebo Dose 2/30 13OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste
or smell
Diarrhea
C4591001 1141
11411020 (USA/29/M) Placebo Dose 2/6 29AUG2020 04SEP2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1141
11411088
(USA/52/M)* Placebo Dose 2/29 07OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Sore throat
C4591001 1141
11411161 (USA/25/F)* Placebo Dose 2/47 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
Diarrhea
Vomiting
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 34
FDA-CBER-2021-5683-0020214
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1141
11411162
(USA/20/M)* Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1147
11471004 (USA/62/M) Placebo Dose 1/22 24AUG2020 28AUG2020 Neg/Neg/Unk New or increased
cough Pos/
Sore throat
C4591001 1147
11471035 (USA/52/M) Placebo Dose 1/18 23AUG2020 11SEP2020 Neg/Neg/Unk New or increased
cough Pos/Pos
Chills
Sore throat
C4591001 1149
11491066 (USA/40/M) Placebo Dose 1/13 24AUG2020 04SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1149
11491113
(USA/69/M)* BNT162b2 (30
μg) Dose 2/44 23OCT2020 24OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Vomiting
C4591001 1152
11521363
(USA/19/M)* Placebo Dose 2/9 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1152
11521372 (USA/28/F)* Placebo Dose 2/32 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 35
FDA-CBER-2021-5683-0020215
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
Sore throat
C4591001 1156
11561006 (USA/45/M) BNT162b2 (30
μg) Dose 1/11 30AUG2020 01SEP2020 Neg/Pos/Neg New or increased
cough Pos/Pos
C4591001 1156
11561033 (USA/55/F) Placebo Dose 1/11 05SEP2020 26SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste
or smell
C4591001 1156
11561044 (USA/63/M) Placebo Dose 1/6 01SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1156
11561064 (USA/23/F) BNT162b2 (30
μg) Dose 1/7 04SEP2020 18SEP2020 Neg/Neg/Pos Fever Pos/
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 36
FDA-CBER-2021-5683-0020216
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
Diarrhea
C4591001 1162
11621044 (USA/22/M) BNT162b2 (30
μg) Dose 1/5 10AUG2020 Neg/Unk/Pos Fever Pos/
Chills
New loss of taste
or smell
Sore throat
C4591001 1162
11621075 (USA/40/F)* Placebo Dose 2/67 06NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1163
11631113
(USA/25/M)* Placebo Dose 2/43 14OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
Sore throat
C4591001 1163
11631135
(USA/42/M)* Placebo Dose 2/21 30SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Diarrhea
C4591001 1167
11671152 (USA/41/F)* Placebo Dose 2/26 20OCT2020 Neg/Neg/Neg Fever Pos/Pos
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 37
FDA-CBER-2021-5683-0020217
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
Diarrhea
C4591001 1167
11671157
(USA/58/M)* Placebo Dose 2/16 14OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1168
11681004
(USA/54/M)* Placebo Dose 2/67 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1168
11681007 (USA/33/F)* Placebo Dose 2/36 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 38
FDA-CBER-2021-5683-0020218
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1168
11681008
(USA/37/M)* Placebo Dose 2/35 05OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
C4591001 1168
11681114 (USA/46/F)* Placebo Dose 2/23 13OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
Diarrhea
C4591001 1168
11681117
(USA/37/M)* Placebo Dose 2/45 04NOV2020 Neg/Neg/Neg Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 39
FDA-CBER-2021-5683-0020219
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
C4591001 1169
11691007 (USA/28/F) Placebo Dose 2/19 11OCT2020 Neg/Unk/Neg New or increased
shortness of breath Pos/
New loss of taste
or smell
C4591001 1169
11691058 (USA/32/M) Placebo Dose 1/16 01OCT2020 11OCT2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
Chills
C4591001 1170
11701089 (USA/25/F)* Placebo Dose 2/16 01OCT2020 Neg/Neg/Neg Fever Pos/
Sore throat
C4591001 1171
11711269 (USA/61/M) Placebo Dose 2/5 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1174
11741053 (USA/24/F) Placebo Dose 2/5 05OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1178
11781065
(USA/48/M)* Placebo Dose 2/23 13OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 40
FDA-CBER-2021-5683-0020220
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1178
11781238 (USA/60/F)* Placebo Dose 2/16 29OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1178
11781276 (USA/72/M) BNT162b2 (30
μg) Dose 2/7 27OCT2020 Neg/Neg/Unk New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1178
11781280
(USA/58/M)* Placebo Dose 2/9 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 41
FDA-CBER-2021-5683-0020221
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1179
11791085
(USA/34/M)* Placebo Dose 2/34 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1179
11791138 (USA/36/M) BNT162b2 (30
μg) Dose 1/8 31OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
New or increased
muscle pain
Sore throat
C4591001 1194
11941061 (DEU/51/M) BNT162b2 (30
μg) Dose 1/6 24OCT2020 Neg/Pos/Unk New loss of taste
or smell Pos/Pos
C4591001 1203
12031037 (DEU/36/M) BNT162b2 (30
μg) Dose 1/6 26OCT2020 30OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
C4591001 1207
12071024 (TUR/43/M) BNT162b2 (30
μg) Dose 1/8 04NOV2020 Unk/Neg/Unk Chills Pos/
New loss of taste
or smell
C4591001 1209
12091013 (TUR/32/M) BNT162b2 (30
μg) Dose 1/6 07NOV2020 09NOV2020 Neg/Pos/Unk New loss of taste
or smell Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 42
FDA-CBER-2021-5683-0020222
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Vomiting
C4591001 1221
12211002 (USA/43/M) Placebo Dose 1/20 01NOV2020 Neg/Neg/Unk Chills Unk/Pos
Vomiting
C4591001 1223
12231005 (USA/20/F)* Placebo Dose 2/51 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Sore throat
C4591001 1223
12231096 (USA/77/F)* Placebo Dose 2/48 11NOV2020 12NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1226
12261309
(BRA/61/M)* Placebo Dose 2/40 20OCT2020 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1226
12261360 (BRA/26/M) Placebo Dose 2/1 11SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste
or smell
C4591001 1226
12261363
(BRA/48/F)* Placebo Dose 2/23 03OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste
or smell
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 43
FDA-CBER-2021-5683-0020223
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
Vomiting
C4591001 1226
12261599
(BRA/41/F)* BNT162b2 (30
μg) Dose 2/36 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
Sore throat
C4591001 1226
12261624
(BRA/52/M)* Placebo Dose 2/34 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1226
12261660
(BRA/27/F)* Placebo Dose 2/37 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1226
12261894 (BRA/28/M) Placebo Dose 1/5 29SEP2020 02OCT2020 Neg/Neg/Pos Fever Pos/
Chills
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 44
FDA-CBER-2021-5683-0020224
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1226
12261964
(BRA/27/F)* Placebo Dose 2/9 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1226
12262111
(BRA/51/M)* Placebo Dose 2/12 10NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/
C4591001 1226
12262189 (BRA/22/M) Placebo Dose 1/14 27OCT2020 01NOV2020 Neg/Neg/Unk New or increased
cough Pos/
C4591001 1226
12262267 (BRA/27/F) Placebo Dose 1/2 18OCT2020 Neg/Pos/Pos New loss of taste
or smell Pos/
C4591001 1231
12311043
(ARG/46/M)* Placebo Dose 2/40 10OCT2020 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1231
12311054 (ARG/37/M) Placebo Dose 1/8 18AUG2020 18AUG2020 Neg/Neg/Unk Fever Pos/
C4591001 1231
12311087 (ARG/44/M) Placebo Dose 1/15 26AUG2020 15SEP2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 45
FDA-CBER-2021-5683-0020225
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste
or smell
Diarrhea
Vomiting
C4591001 1231
12311147 (ARG/31/M) Placebo Dose 1/5 17AUG2020 30AUG2020 Neg/Neg/Neg New loss of taste
or smell Pos/
Sore throat
C4591001 1231
12311195 (ARG/53/M) Placebo Dose 1/16 29AUG2020 10OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1231
12311267
(ARG/67/M)* Placebo Dose 2/24 26SEP2020 07OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1231
12311356 (ARG/30/F) Placebo Dose 1/17 31AUG2020 18SEP2020 Neg/Neg/Unk New or increased
muscle pain Pos/
New loss of taste
or smell
C4591001 1231
12311391 (ARG/28/F) Placebo Dose 1/10 24AUG2020 Neg/Neg/Unk New or increased
cough Pos/
New or increased
muscle pain
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 46
FDA-CBER-2021-5683-0020226
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12311407
(ARG/63/M)* Placebo Dose 2/24 27SEP2020 06OCT2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
Diarrhea
C4591001 1231
12311431 (ARG/21/M) Placebo Dose 1/3 17AUG2020 07SEP2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1231
12311531
(ARG/35/M)* Placebo Dose 2/9 16SEP2020 27SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1231
12311532 (ARG/50/M) BNT162b2 (30
μg) Dose 1/8 23AUG2020 25AUG2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 47
FDA-CBER-2021-5683-0020227
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12311549 (ARG/58/F) Placebo Dose 1/13 28AUG2020 13SEP2020 Neg/Neg/Pos Fever Pos/
New loss of taste
or smell
C4591001 1231
12311556
(ARG/24/M)* Placebo Dose 2/45 21OCT2020 09NOV2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1231
12311560
(ARG/44/M)* Placebo Dose 2/70 12NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1231
12311568 (ARG/43/M) Placebo Dose 1/6 21AUG2020 10SEP2020 Neg/Neg/Pos New or increased
muscle pain Pos/
New loss of taste
or smell
C4591001 1231
12311641 (ARG/25/M) BNT162b2 (30
μg) Dose 1/10 25AUG2020 15SEP2020 Neg/Pos/Pos New loss of taste
or smell Pos/
C4591001 1231
12311651
(ARG/52/F)* Placebo Dose 2/8 14SEP2020 01OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
Vomiting
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 48
FDA-CBER-2021-5683-0020228
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12311656 (ARG/20/F) Placebo Dose 1/24 08SEP2020 20SEP2020 Neg/Neg/Pos New or increased
muscle pain Pos/
New loss of taste
or smell
Sore throat
C4591001 1231
12311664
(ARG/34/F)* Placebo Dose 2/9 15SEP2020 03OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1231
12311754
(ARG/54/M)* Placebo Dose 2/38 14OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12311764
(ARG/34/M)* Placebo Dose 2/63 09NOV2020 09NOV2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1231
12311911 (ARG/41/F) BNT162b2 (30
μg) Dose 1/8 25AUG2020 30AUG2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1231
12311982
(ARG/41/F)* Placebo Dose 2/37 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 49
FDA-CBER-2021-5683-0020229
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1231
12312130 (ARG/64/F) Placebo Dose 1/3 20AUG2020 27AUG2020 Neg/Pos/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1231
12312320 (ARG/51/F) Placebo Dose 1/61 18OCT2020 Neg/Neg/Unk New or increased
cough Pos/
New loss of taste
or smell
C4591001 1231
12312334 (ARG/40/F) Placebo Dose 1/15 02SEP2020 Neg/Neg/Pos New loss of taste
or smell Pos/
C4591001 1231
12312339 (ARG/22/F) BNT162b2 (30
μg) Dose 1/6 24AUG2020 23SEP2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1231
12312375 (ARG/43/F) BNT162b2 (30
μg) Dose 1/9 27AUG2020 07SEP2020 Neg/Neg/Pos New loss of taste
or smell Pos/
Sore throat
Vomiting
C4591001 1231
12312479
(ARG/43/M)* Placebo Dose 2/30 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste
or smell
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 50
FDA-CBER-2021-5683-0020230
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12312507
(ARG/47/F)* Placebo Dose 2/10 17SEP2020 28SEP2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1231
12312571 (ARG/62/M) Placebo Dose 1/13 01SEP2020 13SEP2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
C4591001 1231
12312630
(ARG/39/F)* Placebo Dose 2/44 23OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1231
12312635
(ARG/71/M)* Placebo Dose 2/27 04OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
Sore throat
C4591001 1231
12312660 (ARG/35/M) Placebo Dose 1/23 11SEP2020 23SEP2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 51
FDA-CBER-2021-5683-0020231
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
Sore throat
C4591001 1231
12312679 (ARG/32/M) Placebo Dose 2/4 14SEP2020 14NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Diarrhea
C4591001 1231
12312752 (ARG/36/M) Placebo Dose 1/17 06SEP2020 24SEP2020 Neg/Neg/Pos Fever Pos/
New or increased
cough
C4591001 1231
12312763 (ARG/43/F) Placebo Dose 1/19 08SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste
or smell
C4591001 1231
12312805 (ARG/33/M) BNT162b2 (30
μg) Dose 1/17 06SEP2020 08SEP2020 Neg/Pos/Neg New or increased
cough Pos/
C4591001 1231
12312867
(ARG/40/F)* Placebo Dose 2/35 14OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/
New loss of taste
or smell
Diarrhea
C4591001 1231
12312914
(ARG/50/M)* Placebo Dose 2/43 26OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 52
FDA-CBER-2021-5683-0020232
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
muscle pain
Sore throat
C4591001 1231
12313006 (ARG/50/F) BNT162b2 (30
μg) Dose 1/2 22AUG2020 30AUG2020 Neg/Pos/Pos Fever Pos/
Chills
Sore throat
C4591001 1231
12313068 (ARG/41/M) Placebo Dose 1/5 26AUG2020 31AUG2020 Neg/Neg/Pos New or increased
muscle pain Pos/
New loss of taste
or smell
C4591001 1231
12313069 (ARG/36/M) Placebo Dose 1/9 30AUG2020 19SEP2020 Neg/Neg/Pos New or increased
cough Pos/
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1231
12313090 (ARG/57/M) Placebo Dose 1/13 03SEP2020 28SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
C4591001 1231
12313103 (ARG/73/M) Placebo Dose 1/10 31AUG2020 10SEP2020 Neg/Neg/Pos Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 53
FDA-CBER-2021-5683-0020233
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1231
12313125 (ARG/48/M) Placebo Dose 1/76 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste
or smell
C4591001 1231
12313182
(ARG/33/M)* Placebo Dose 2/10 20SEP2020 19OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
New loss of taste
or smell
C4591001 1231
12313225 (ARG/55/F) BNT162b2 (30
μg) Dose 1/3 24AUG2020 24AUG2020 Neg/Pos/Pos New loss of taste
or smell Pos/
C4591001 1231
12313296
(ARG/49/F)* Placebo Dose 2/25 04OCT2020 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
C4591001 1231
12313357 (ARG/31/M) BNT162b2 (30
μg) Dose 1/3 25AUG2020 30AUG2020 Neg/Neg/Pos Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 54
FDA-CBER-2021-5683-0020234
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12313395 (ARG/39/M) Placebo Dose 1/2 24AUG2020 31AUG2020 Neg/Pos/Pos New loss of taste
or smell Pos/
C4591001 1231
12313400
(ARG/46/M)* Placebo Dose 2/37 19OCT2020 28OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
C4591001 1231
12313422
(ARG/34/M)* Placebo Dose 2/44 28OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Diarrhea
C4591001 1231
12313457 (ARG/60/M) Placebo Dose 1/5 27AUG2020 18SEP2020 Unk/Neg/Pos Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1231
12313510 (ARG/29/F) Placebo Dose 1/13 04SEP2020 07SEP2020 Unk/Neg/Pos Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 55
FDA-CBER-2021-5683-0020235
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
C4591001 1231
12313520
(ARG/28/F)* Placebo Dose 2/8 22SEP2020 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
Sore throat
C4591001 1231
12313657 (ARG/48/F) Placebo Dose 1/11 03SEP2020 18SEP2020 Neg/Neg/Pos Chills Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12313662 (ARG/27/M) BNT162b2 (30
μg) Dose 1/8 31AUG2020 10SEP2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Diarrhea
C4591001 1231
12313668
(ARG/33/M)* Placebo Dose 2/12 24SEP2020 02OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
Sore throat
C4591001 1231
12313709 (ARG/38/M) BNT162b2 (30
μg) Dose 1/14 06SEP2020 03OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 56
FDA-CBER-2021-5683-0020236
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12313787
(ARG/58/M)* Placebo Dose 2/48 02NOV2020 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1231
12313895
(ARG/50/F)* Placebo Dose 2/21 03OCT2020 17OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste
or smell
C4591001 1231
12314112
(ARG/52/M)* Placebo Dose 2/42 28OCT2020 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1231
12314301 (ARG/56/M) BNT162b2 (30
μg) Dose 1/4 29AUG2020 30SEP2020 Neg/Neg/Pos New or increased
muscle pain Pos/
New loss of taste
or smell
C4591001 1231
12314308
(ARG/31/F)* Placebo Dose 2/15 30SEP2020 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
Vomiting
C4591001 1231
12314314 (ARG/33/F) BNT162b2 (30
μg) Dose 1/2 27AUG2020 29AUG2020 Neg/Pos/Unk Fever Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 57
FDA-CBER-2021-5683-0020237
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12314477 (ARG/36/M) Placebo Dose 2/16 03OCT2020 15OCT2020 Pos/Neg/Neg New or increased
cough Pos/
New loss of taste
or smell
C4591001 1231
12314492 (ARG/23/F) Placebo Dose 1/2 28AUG2020 09SEP2020 Neg/Pos/Pos Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste
or smell
C4591001 1231
12314534
(ARG/18/F)* Placebo Dose 2/21 05OCT2020 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12314622
(ARG/32/F)* Placebo Dose 2/15 01OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 58
FDA-CBER-2021-5683-0020238
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
New loss of taste
or smell
C4591001 1231
12314700 (ARG/43/M) BNT162b2 (30
μg) Dose 1/7 03SEP2020 04OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1231
12315636
(ARG/53/F)* Placebo Dose 2/35 23OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1231
12315637
(ARG/40/F)* Placebo Dose 2/11 29SEP2020 08OCT2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
New loss of taste
or smell
C4591001 1235
12351027 (USA/50/M) Placebo Dose 1/18 23SEP2020 03OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 59
FDA-CBER-2021-5683-0020239
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
shortness of breath
Chills
Vomiting
C4591001 1235
12351071 (USA/50/M) Placebo Dose 1/8 21SEP2020 25SEP2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
C4591001 1235
12351093 (USA/30/F)* BNT162b2 (30
μg) Dose 2/32 08NOV2020 14NOV2020 Neg/Neg/Neg New loss of taste
or smell Pos/
C4591001 1235
12351187 (USA/23/F) Placebo Dose 1/8 23OCT2020 Neg/Neg/Unk Fever Pos/
New or increased
cough
Sore throat
C4591001 1235
12351188 (USA/36/F) BNT162b2 (30
μg) Dose 1/6 21OCT2020 Neg/Neg/Unk Chills Pos/
C4591001 1241
12411260 (BRA/39/M) Placebo Dose 1/12 30AUG2020 13SEP2020 Neg/Neg/Unk New or increased
muscle pain Pos/
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 60
FDA-CBER-2021-5683-0020240
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
C4591001 1241
12411688 (BRA/29/M) Placebo Dose 1/13 27SEP2020 15OCT2020 Neg/Neg/Pos New or increased
cough Pos/Pos
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste
or smell
Sore throat
C4591001 1241
12411695 (BRA/44/F) Placebo Dose 1/4 18SEP2020 05OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1241
12411885 (BRA/23/M) BNT162b2 (30
μg) Dose 2/14 22OCT2020 24OCT2020 Pos/Neg/Neg Sore throat Pos/Neg
C4591001 1241
12412017
(BRA/59/M)* Placebo Dose 2/9 29OCT2020 Neg/Neg/Neg Fever Pos/Pos
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 61
FDA-CBER-2021-5683-0020241
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1241
12412018
(BRA/55/F)* Placebo Dose 2/8 28OCT2020 Neg/Neg/Neg Fever Pos/Pos
Sore throat
C4591001 1241
12412215 (BRA/39/M) Placebo Dose 2/3 06NOV2020 Neg/Neg/Pos Fever Pos/
Chills
New or increased
muscle pain
New loss of taste
or smell
C4591001 1241
12412355 (BRA/38/F) Placebo Dose 1/3 21OCT2020 04NOV2020 Neg/Neg/Pos New loss of taste
or smell Pos/
Diarrhea
C4591001 1241
12412568 (BRA/60/F) Placebo Dose 1/7 10NOV2020 Unk/Neg/Unk Fever Unk/Pos
New or increased
cough
Vomiting
C4591001 1247
12471066 (ZAF/58/F) Placebo Dose 1/17 15OCT2020 Neg/Neg/Unk New or increased
cough Pos/
New or increased
shortness of breath
C4591001 1247
12471085 (ZAF/54/F) Placebo Dose 2/12 30OCT2020 03NOV2020 Neg/Unk/Neg New or increased
cough Pos/
Chills
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 62
FDA-CBER-2021-5683-0020242
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Diarrhea
C4591001 1251
12511159 (USA/37/F)* Placebo Dose 2/26 26OCT2020 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste
or smell
C4591001 1251
12511207 (USA/48/M) Placebo Dose 1/3 25SEP2020 29SEP2020 Neg/Neg/Pos New or increased
cough Pos/
C4591001 1251
12511209 (USA/62/M) Placebo Dose 2/7 19OCT2020 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 4444
44441025 (ARG/51/M) Placebo Dose 1/8 28SEP2020 05OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste
or smell
C4591001 4444
44441044 (ARG/35/F) Placebo Dose 1/13 03OCT2020 10OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Diarrhea
C4591001 4444
44441092
(ARG/64/M)* Placebo Dose 2/23 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 63
FDA-CBER-2021-5683-0020243
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste
or smell
Sore throat
C4591001 4444
44441144
(ARG/38/M)* Placebo Dose 2/26 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
New loss of taste
or smell
Diarrhea
C4591001 4444
44441204
(ARG/59/F)* BNT162b2 (30
μg) Dose 2/21 02NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste
or smell
C4591001 4444
44441224
(ARG/52/M)* Placebo Dose 2/13 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 4444
44441253 (ARG/49/M) Placebo Dose 1/5 25SEP2020 09OCT2020 Pos/Neg/Neg New or increased
cough Pos/
Sore throat
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 64
FDA-CBER-2021-5683-0020244
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 4444
44441560 (ARG/38/F) Placebo Dose 1/7 29SEP2020 07OCT2020 Neg/Neg/Pos New or increased
muscle pain Pos/
Sore throat
C4591001 4444
44441563
(ARG/38/M)* Placebo Dose 2/8 21OCT2020 Neg/Neg/Neg New loss of taste
or smell Pos/
Diarrhea
C4591001 4444
44441787 (ARG/62/M) Placebo Dose 1/4 26SEP2020 27SEP2020 Pos/Neg/Neg New or increased
cough Pos/
C4591001 4444
44442188 (ARG/24/M) BNT162b2 (30
μg) Dose 1/9 05OCT2020 Neg/Pos/Pos New or increased
cough Pos/
C4591001 4444
44442304 (ARG/49/M) Placebo Dose 2/12 26OCT2020 11NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste
or smell
Sore throat
Abbreviations: ARG = Argentina; BRA = Brazil; DEU = Germany; NAAT = nucleic acid amplification test; N -binding = SARS -CoV -2 nucleoprotein –
binding; Neg = negative; Pos = positive; R1 = repeat central swab 1; SARS -CoV -2 = severe acute respiratory syndrome co ronavirus 2; Unk = unknown;
ZAF = South Africa.
Note: * indicates subject in the evaluable efficacy (7 days) population with first COVID -19 occurrence from 7 days after Dose 2 and without evidence of
infection prior to 7 days after Dose 2.
Note: HIV -positi ve subjects are included in this listing but not included in the analyses of the overall study objectives.
Note: † = HIV -positive subject.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
b. SARS -CoV -2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS -CoV -2 test, Roche cobas® SARS -CoV -2 real -time RT -
PCR test (EUA200009/A001), or Abbott RealTime SARS -CoV -2 assay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (16:08) Source Data: adsympt Table Generation: 18NOV2020 (08:45)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_Efficacy_FA_164/adsympt_l001_sympt_ d1_aai
090177e1959af312\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 65
FDA-CBER-2021-5683-0020245
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1003
10031122 (USA/48/M) Placebo Dose 2/77 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1006
10061012 (USA/53/M) Placebo Dose 2/68 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1006
10061066 (USA/39/F) Placebo Dose 2/59 11NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1006
10061084 (USA/27/F) Placebo Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1006
10061091 (USA/20/F) Placebo Dose 2/50 30OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1006
10061114 (USA/21/M) Placebo Dose 2/35 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste or
smell
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 66
FDA-CBER-2021-5683-0020246
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1008
10081011 (USA/55/F) Placebo Dose 2/52 22OCT2020 31OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1008
10081048 (USA/38/F) Placebo Dose 2/60 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1008
10081130 (USA/52/F) Placebo Dose 2/32 17OCT2020 29OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
C4591001 1008
10081214 (USA/62/M) Placebo Dose 2/42 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1008
10081319 (USA/79/F) Placebo Dose 2/31 04NOV2020 Neg/Neg/Neg Chills Pos/
C4591001 1008
10081356 (USA/63/M) Placebo Dose 2/25 31OCT2020 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 67
FDA-CBER-2021-5683-0020247
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1009
10091128 (USA/51/M) Placebo Dose 2/30 15OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1013
10131288 (USA/53/M) Placebo Dose 2/11 25SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1013
10131475 (USA/49/F) Placebo Dose 2/23 22OCT2020 25OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1016
10161003 (USA/23/F) Placebo Dose 2/57 14OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 68
FDA-CBER-2021-5683-0020248
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
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
smell Pos/
Sore throat
C4591001 1016
10161017 (USA/18/F) Placebo Dose 2/19 07SEP2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1016
10161035 (USA/70/F) Placebo Dose 2/67 29OCT2020 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1016
10161048 (USA/52/F) Placebo Dose 2/75 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1016
10161183 (USA/31/F) Placebo Dose 2/32 16OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/ (R1 Pos)
New or increased
cough
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 69
FDA-CBER-2021-5683-0020249
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Diarrhea
Vomiting
C4591001 1016
10161207 (USA/62/F) Placebo Dose 2/27 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1018
10181198 (USA/50/F) Placebo Dose 2/55 04NOV2020 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1019
10191038 (USA/47/F) Placebo Dose 2/61 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste or
smell
C4591001 1019
10191184 (USA/52/M) Placebo Dose 2/36 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 70
FDA-CBER-2021-5683-0020250
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
Vomiting
C4591001 1028
10281038 (USA/53/F) Placebo Dose 2/31 10OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1028
10281100 (USA/47/F) Placebo Dose 2/19 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1028
10281132 (USA/61/M) Placebo Dose 2/14 11OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1028
10281138 (USA/38/F) Placebo Dose 2/25 23OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Sore throat
Diarrhea
C4591001 1037
10371036 (USA/62/M) Placebo Dose 2/52 31OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 71
FDA-CBER-2021-5683-0020251
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Chills
C4591001 1037
10371280 (USA/58/M) Placebo Dose 2/28 10NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1038
10381051 (USA/69/M) Placebo Dose 2/51 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1039
10391025 (USA/55/F) Placebo Dose 2/40 25OCT2020 03NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Sore throat
C4591001 1046
10461058 (USA/44/F) Placebo Dose 2/62 09NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1047
10471024 (USA/63/F) BNT162b2 (30
μg) Dose 2/37 16OCT2020 18OCT2020 Neg/Neg/Neg Fever Pos/
Diarrhea
Vomiting
C4591001 1068
10681082 (USA/58/M) Placebo Dose 2/42 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 72
FDA-CBER-2021-5683-0020252
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
shortness of breath
Sore throat
C4591001 1068
10681110 (USA/30/F) Placebo Dose 2/22 16OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1071
10711022 (USA/47/M) Placebo Dose 2/72 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1071
10711058 (USA/72/F) Placebo Dose 2/60 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1072
10721057 (USA/70/M) Placebo Dose 2/41 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1077
10771195 (USA/73/F) Placebo Dose 2/40 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1079
10791046 (USA/55/F) Placebo Dose 2/62 26OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 73
FDA-CBER-2021-5683-0020253
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1079
10791054 (USA/28/F) Placebo Dose 2/63 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1081
10811151 (USA/79/F) Placebo Dose 2/10 30SEP2020 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1082
10821016 (USA/46/F) Placebo Dose 2/44 06OCT2020 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1085
10851293 (USA/63/F) Placebo Dose 2/37 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste or
smell
C4591001 1088
10881219 (USA/63/M) Placebo Dose 2/17 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1088
10881233 (USA/47/M) Placebo Dose 2/15 02NOV2020 Neg/Neg/Neg Fever Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 74
FDA-CBER-2021-5683-0020254
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Chills
Sore throat
C4591001 1089
10891235 (USA/29/F) Placebo Dose 2/47 08NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1090
10901121 (USA/58/F) Placebo Dose 2/49 18OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/
New loss of taste or
smell
C4591001 1090
10901353 (USA/63/M) Placebo Dose 2/40 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1091
10911203 (USA/43/M) Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Unk/Pos
New or increased
muscle pain
C4591001 1092
10921021 (USA/60/F) Placebo Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 75
FDA-CBER-2021-5683-0020255
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1092
10921130 (USA/53/M) Placebo Dose 2/18 09OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New loss of taste or
smell
Sore throat
Diarrhea
C4591001 1093
10931081 (USA/67/F) Placebo Dose 2/19 05OCT2020 19OCT2020 Neg/Neg/Neg Sore throat Pos/
C4591001 1095
10951238 (USA/63/F) Placebo Dose 2/19 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1095
10951260 (USA/25/M) Placebo Dose 2/9 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 76
FDA-CBER-2021-5683-0020256
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1096
10961172 (USA/51/M) Placebo Dose 2/49 06NOV2020 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1096
10961258 (USA/55/F) Placebo Dose 2/25 22OCT2020 Neg/Neg/Neg New or increased
cough Pos/Pos
New or increased
muscle pain
Sore throat
C4591001 1098
10981062 (USA/63/F) Placebo Dose 2/32 17OCT2020 20OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1101
11011095 (USA/60/M) Placebo Dose 2/20 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1107
11071171 (USA/39/M) Placebo Dose 2/58 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
C4591001 1109
11091067 (USA/42/M) Placebo Dose 2/84 11NOV2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
Sore throat
C4591001 1109
11091092 (USA/18/M) Placebo Dose 2/70 31OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 77
FDA-CBER-2021-5683-0020257
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1109
11091323 (USA/64/M) Placebo Dose 2/47 31OCT2020 02NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1109
11091416 (USA/46/F) Placebo Dose 2/41 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1109
11091448 (USA/46/F) Placebo Dose 2/9 06OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/ (R1 Pos)
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1109
11091482 (USA/63/M) Placebo Dose 2/28 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1110
11101050 (USA/47/M) BNT162b2 (30
μg) Dose 2/76 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 78
FDA-CBER-2021-5683-0020258
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
Sore throat
C4591001 1110
11101136 (USA/62/M) Placebo Dose 2/52 04NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Diarrhea
C4591001 1110
11101162 (USA/51/M) BNT162b2 (30
μg) Dose 2/34 24OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1111
11111010 (USA/75/M) Placebo Dose 2/45 04OCT2020 05OCT2020 Neg/Neg/Neg Fever Pos/
Chills
C4591001 1116
11161075 (USA/73/M) Placebo Dose 2/43 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
C4591001 1117
11171010 (USA/72/F) Placebo Dose 2/34 11OCT2020 19OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1118
11181088 (USA/73/M) Placebo Dose 2/36 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 79
FDA-CBER-2021-5683-0020259
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1120
11201115 (USA/19/F) Placebo Dose 2/73 06NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1122
11221025 (USA/40/M) Placebo Dose 2/32 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1123
11231073 (USA/25/F) Placebo Dose 2/10 10SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/Pos
Chills
New or increased
muscle pain
Sore throat
C4591001 1123
11231086 (USA/35/F) Placebo Dose 2/57 27OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
C4591001 1123
11231117 (USA/55/F) Placebo Dose 2/64 10NOV2020 Neg/Neg/Neg Chills Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 80
FDA-CBER-2021-5683-0020260
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
C4591001 1123
11231214 (USA/60/F) Placebo Dose 2/34 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New loss of taste or
smell
Sore throat
C4591001 1123
11231255 (USA/76/M) Placebo Dose 2/20 24OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1123
11231256 (USA/72/F) Placebo Dose 2/24 28OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1123
11231284 (USA/67/M) Placebo Dose 2/12 24OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1125
11251006 (USA/35/M) Placebo Dose 2/42 11OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 81
FDA-CBER-2021-5683-0020261
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1125
11251014 (USA/45/F) Placebo Dose 2/59 30OCT2020 Neg/Neg/Neg Fever Pos/
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 Neg/Neg/Neg New or increased
cough Pos/
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/
Chills
New or increased
muscle pain
Sore throat
C4591001 1125
11251049 (USA/52/M) Placebo Dose 2/50 27OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Sore throat
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 82
FDA-CBER-2021-5683-0020262
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1125
11251109 (USA/46/F) Placebo Dose 2/51 04NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1125
11251114 (USA/59/M) Placebo Dose 2/38 22OCT2020 Neg/Neg/Neg Fever Pos/Pos
C4591001 1125
11251124 (USA/39/M) Placebo Dose 2/53 08NOV2020 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
C4591001 1125
11251215 (USA/43/M) Placebo Dose 2/25 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1126
11261017 (USA/34/F) Placebo Dose 2/50 20OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1128
11281165 (USA/26/F) Placebo Dose 2/46 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1131
11311100 (USA/64/M) Placebo Dose 2/58 12NOV2020 Neg/Neg/Neg Fever Pos/
Chills
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 83
FDA-CBER-2021-5683-0020263
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste or
smell
C4591001 1131
11311138 (USA/45/F) Placebo Dose 2/45 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
C4591001 1133
11331209 (USA/30/M) Placebo Dose 2/32 10OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1134
11341022 (USA/66/M) Placebo Dose 2/29 29SEP2020 03OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1135
11351207 (USA/33/F) Placebo Dose 2/30 13OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste or
smell
Diarrhea
C4591001 1141
11411088 (USA/52/M) Placebo Dose 2/29 07OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Sore throat
C4591001 1141
11411161 (USA/25/F) Placebo Dose 2/47 08NOV2020 Neg/Neg/Neg Fever Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 84
FDA-CBER-2021-5683-0020264
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
muscle pain
Diarrhea
Vomiting
C4591001 1141
11411162 (USA/20/M) Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1149
11491113 (USA/69/M) BNT162b2 (30
μg) Dose 2/44 23OCT2020 24OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Vomiting
C4591001 1152
11521363 (USA/19/M) Placebo Dose 2/9 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1152
11521372 (USA/28/F) Placebo Dose 2/32 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1162
11621075 (USA/40/F) Placebo Dose 2/67 06NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1163
11631113 (USA/25/M) Placebo Dose 2/43 14OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 85
FDA-CBER-2021-5683-0020265
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Chills
Sore throat
C4591001 1163
11631135 (USA/42/M) Placebo Dose 2/21 30SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Diarrhea
C4591001 1167
11671152 (USA/41/F) Placebo Dose 2/26 20OCT2020 Neg/Neg/Neg Fever Pos/Pos
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Diarrhea
C4591001 1167
11671157 (USA/58/M) Placebo Dose 2/16 14OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 86
FDA-CBER-2021-5683-0020266
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
C4591001 1168
11681004 (USA/54/M) Placebo Dose 2/67 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1168
11681007 (USA/33/F) Placebo Dose 2/36 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1168
11681008 (USA/37/M) Placebo Dose 2/35 05OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1168
11681114 (USA/46/F) Placebo Dose 2/23 13OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 87
FDA-CBER-2021-5683-0020267
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Diarrhea
C4591001 1168
11681117 (USA/37/M) Placebo Dose 2/45 04NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1170
11701089 (USA/25/F) Placebo Dose 2/16 01OCT2020 Neg/Neg/Neg Fever Pos/
Sore throat
C4591001 1178
11781065 (USA/48/M) Placebo Dose 2/23 13OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1178
11781238 (USA/60/F) Placebo Dose 2/16 29OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 88
FDA-CBER-2021-5683-0020268
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
Sore throat
C4591001 1178
11781280 (USA/58/M) Placebo Dose 2/9 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1179
11791085 (USA/34/M) Placebo Dose 2/34 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1223
12231005 (USA/20/F) Placebo Dose 2/51 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Sore throat
C4591001 1223
12231096 (USA/77/F) Placebo Dose 2/48 11NOV2020 12NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1226
12261309 (BRA/61/M) Placebo Dose 2/40 20OCT2020 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 89
FDA-CBER-2021-5683-0020269
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1226
12261363 (BRA/48/F) Placebo Dose 2/23 03OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Vomiting
C4591001 1226
12261599 (BRA/41/F) BNT162b2 (30
μg) Dose 2/36 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
Sore throat
C4591001 1226
12261624 (BRA/52/M) Placebo Dose 2/34 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1226
12261660 (BRA/27/F) Placebo Dose 2/37 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1226
12261964 (BRA/27/F) Placebo Dose 2/9 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 90
FDA-CBER-2021-5683-0020270
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1226
12262111 (BRA/51/M) Placebo Dose 2/12 10NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/
C4591001 1231
12311043 (ARG/46/M) Placebo Dose 2/40 10OCT2020 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1231
12311267 (ARG/67/M) Placebo Dose 2/24 26SEP2020 07OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1231
12311407 (ARG/63/M) Placebo Dose 2/24 27SEP2020 06OCT2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
Diarrhea
C4591001 1231
12311531 (ARG/35/M) Placebo Dose 2/9 16SEP2020 27SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 91
FDA-CBER-2021-5683-0020271
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
C4591001 1231
12311556 (ARG/24/M) Placebo Dose 2/45 21OCT2020 09NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1231
12311560 (ARG/44/M) Placebo Dose 2/70 12NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1231
12311651 (ARG/52/F) Placebo Dose 2/8 14SEP2020 01OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
Vomiting
C4591001 1231
12311664 (ARG/34/F) Placebo Dose 2/9 15SEP2020 03OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1231
12311754 (ARG/54/M) Placebo Dose 2/38 14OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12311764 (ARG/34/M) Placebo Dose 2/63 09NOV2020 09NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 92
FDA-CBER-2021-5683-0020272
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12311982 (ARG/41/F) Placebo Dose 2/37 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12312479 (ARG/43/M) Placebo Dose 2/30 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1231
12312507 (ARG/47/F) Placebo Dose 2/10 17SEP2020 28SEP2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1231
12312630 (ARG/39/F) Placebo Dose 2/44 23OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1231
12312635 (ARG/71/M) Placebo Dose 2/27 04OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 93
FDA-CBER-2021-5683-0020273
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Chills
Sore throat
C4591001 1231
12312867 (ARG/40/F) Placebo Dose 2/35 14OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/
New loss of taste or
smell
Diarrhea
C4591001 1231
12312914 (ARG/50/M) Placebo Dose 2/43 26OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
Sore throat
C4591001 1231
12313182 (ARG/33/M) Placebo Dose 2/10 20SEP2020 19OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
New loss of taste or
smell
C4591001 1231
12313296 (ARG/49/F) Placebo Dose 2/25 04OCT2020 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1231
12313400 (ARG/46/M) Placebo Dose 2/37 19OCT2020 28OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 94
FDA-CBER-2021-5683-0020274
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
C4591001 1231
12313422 (ARG/34/M) Placebo Dose 2/44 28OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Diarrhea
C4591001 1231
12313520 (ARG/28/F) Placebo Dose 2/8 22SEP2020 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
Sore throat
C4591001 1231
12313668 (ARG/33/M) Placebo Dose 2/12 24SEP2020 02OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Sore throat
C4591001 1231
12313787 (ARG/58/M) Placebo Dose 2/48 02NOV2020 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1231
12313895 (ARG/50/F) Placebo Dose 2/21 03OCT2020 17OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 95
FDA-CBER-2021-5683-0020275
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste or
smell
C4591001 1231
12314112 (ARG/52/M) Placebo Dose 2/42 28OCT2020 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1231
12314308 (ARG/31/F) Placebo Dose 2/15 30SEP2020 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
Vomiting
C4591001 1231
12314534 (ARG/18/F) Placebo Dose 2/21 05OCT2020 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12314622 (ARG/32/F) Placebo Dose 2/15 01OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 96
FDA-CBER-2021-5683-0020276
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste or
smell
C4591001 1231
12315636 (ARG/53/F) Placebo Dose 2/35 23OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1231
12315637 (ARG/40/F) Placebo Dose 2/11 29SEP2020 08OCT2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1235
12351093 (USA/30/F) BNT162b2 (30
μg) Dose 2/32 08NOV2020 14NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1241
12412017 (BRA/59/M) Placebo Dose 2/9 29OCT2020 Neg/Neg/Neg Fever Pos/Pos
New or increased
muscle pain
C4591001 1241
12412018 (BRA/55/F) Placebo Dose 2/8 28OCT2020 Neg/Neg/Neg Fever Pos/Pos
Sore throat
C4591001 1251
12511159 (USA/37/F) Placebo Dose 2/26 26OCT2020 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste or
smell
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 97
FDA-CBER-2021-5683-0020277
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 4444
44441092 (ARG/64/M) Placebo Dose 2/23 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 4444
44441144 (ARG/38/M) Placebo Dose 2/26 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 4444
44441204 (ARG/59/F) BNT162b2 (30
μg) Dose 2/21 02NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste or
smell
C4591001 4444
44441224 (ARG/52/M) Placebo Dose 2/13 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 98
FDA-CBER-2021-5683-0020278
16.2.8.2 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and Without Evidence of
Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 4444
44441563 (ARG/38/M) Placebo Dose 2/8 21OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Diarrhea
Abbreviations: ARG = Argentina; BRA = Brazil; NAAT = nucleic acid amplification test; N -binding = SARS -CoV -2 nucleoprotein –binding; Neg =
negative; Pos = positive; R1 = repeat central swab 1; SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; Un k = unknown.
Note: HIV -positive subjects are included in this listing but not included in the analyses of the overall study objectives.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
b. SARS -CoV -2 NA AT results from the local lab are based on the Cepheid Xpert® Xpress SARS -CoV -2 test, Roche cobas® SARS -CoV -2 real -time RT -
PCR test (EUA200009/A001), or Abbott RealTime SARS -CoV -2 assay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (1 6:08) Source Data: adsympt Table Generation: 18NOV2020 (11:58)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_Efficacy_FA_164/adsympt_l001_sympt_ wo_d2_eval
090177e1959af315\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 99
FDA-CBER-2021-5683-0020279
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1003
10031122 (USA/48/M) Placebo Dose 2/77 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1006
10061012 (USA/53/M) Placebo Dose 2/68 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1006
10061066 (USA/39/F) Placebo Dose 2/59 11NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1006
10061084 (USA/27/F) Placebo Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1006
10061091 (USA/20/F) Placebo Dose 2/50 30OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1006
10061114 (USA/21/M) Placebo Dose 2/35 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste or
smell
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 100
FDA-CBER-2021-5683-0020280
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1008
10081011 (USA/55/F) Placebo Dose 2/52 22OCT2020 31OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1008
10081048 (USA/38/F) Placebo Dose 2/60 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1008
10081130 (USA/52/F) Placebo Dose 2/32 17OCT2020 29OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
C4591001 1008
10081214 (USA/62/M) Placebo Dose 2/42 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1008
10081319 (USA/79/F) Placebo Dose 2/31 04NOV2020 Neg/Neg/Neg Chills Pos/
C4591001 1008
10081356 (USA/63/M) Placebo Dose 2/25 31OCT2020 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 101
FDA-CBER-2021-5683-0020281
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1009
10091128 (USA/51/M) Placebo Dose 2/30 15OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1013
10131288 (USA/53/M) Placebo Dose 2/11 25SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1013
10131475 (USA/49/F) Placebo Dose 2/23 22OCT2020 25OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1016
10161003 (USA/23/F) Placebo Dose 2/57 14OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 102
FDA-CBER-2021-5683-0020282
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
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
smell Pos/
Sore throat
C4591001 1016
10161017 (USA/18/F) Placebo Dose 2/19 07SEP2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1016
10161035 (USA/70/F) Placebo Dose 2/67 29OCT2020 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1016
10161048 (USA/52/F) Placebo Dose 2/75 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1016
10161183 (USA/31/F) Placebo Dose 2/32 16OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/ (R1 Pos)
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 103
FDA-CBER-2021-5683-0020283
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Diarrhea
Vomiting
C4591001 1016
10161207 (USA/62/F) Placebo Dose 2/27 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1016
10161305 (USA/16/M) Placebo Dose 2/8 09NOV2020 Neg/Neg/Pos New or increased
cough Pos/
New loss of taste or
smell
C4591001 1018
10181198 (USA/50/F) Placebo Dose 2/55 04NOV2020 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1019
10191038 (USA/47/F) Placebo Dose 2/61 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 104
FDA-CBER-2021-5683-0020284
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste or
smell
C4591001 1019
10191184 (USA/52/M) Placebo Dose 2/36 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Vomiting
C4591001 1028
10281038 (USA/53/F) Placebo Dose 2/31 10OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1028
10281100 (USA/47/F) Placebo Dose 2/19 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1028
10281132 (USA/61/M) Placebo Dose 2/14 11OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1028
10281138 (USA/38/F) Placebo Dose 2/25 23OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Sore throat
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 105
FDA-CBER-2021-5683-0020285
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Diarrhea
C4591001 1037
10371036 (USA/62/M) Placebo Dose 2/52 31OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1037
10371280 (USA/58/M) Placebo Dose 2/28 10NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1038
10381051 (USA/69/M) Placebo Dose 2/51 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1039
10391025 (USA/55/F) Placebo Dose 2/40 25OCT2020 03NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Sore throat
C4591001 1046
10461058 (USA/44/F) Placebo Dose 2/62 09NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1047
10471024 (USA/63/F) BNT162b2 (30
μg) Dose 2/37 16OCT2020 18OCT2020 Neg/Neg/Neg Fever Pos/
Diarrhea
Vomiting
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 106
FDA-CBER-2021-5683-0020286
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1068
10681082 (USA/58/M) Placebo Dose 2/42 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Sore throat
C4591001 1068
10681110 (USA/30/F) Placebo Dose 2/22 16OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1071
10711022 (USA/47/M) Placebo Dose 2/72 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1071
10711058 (USA/72/F) Placebo Dose 2/60 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1072
10721057 (USA/70/M) Placebo Dose 2/41 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1077
10771195 (USA/73/F) Placebo Dose 2/40 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 107
FDA-CBER-2021-5683-0020287
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
C4591001 1079
10791046 (USA/55/F) Placebo Dose 2/62 26OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1079
10791054 (USA/28/F) Placebo Dose 2/63 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1081
10811151 (USA/79/F) Placebo Dose 2/10 30SEP2020 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1082
10821016 (USA/46/F) Placebo Dose 2/44 06OCT2020 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1085
10851293 (USA/63/F) Placebo Dose 2/37 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New loss of taste or
smell
C4591001 1088
10881219 (USA/63/M) Placebo Dose 2/17 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 108
FDA-CBER-2021-5683-0020288
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
C4591001 1088
10881233 (USA/47/M) Placebo Dose 2/15 02NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
Sore throat
C4591001 1089
10891235 (USA/29/F) Placebo Dose 2/47 08NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1090
10901121 (USA/58/F) Placebo Dose 2/49 18OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/
New loss of taste or
smell
C4591001 1090
10901353 (USA/63/M) Placebo Dose 2/40 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1091
10911203 (USA/43/M) Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Unk/Pos
New or increased
muscle pain
C4591001 1092
10921021 (USA/60/F) Placebo Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 109
FDA-CBER-2021-5683-0020289
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
C4591001 1092
10921130 (USA/53/M) Placebo Dose 2/18 09OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New loss of taste or
smell
Sore throat
Diarrhea
C4591001 1093
10931081 (USA/67/F) Placebo Dose 2/19 05OCT2020 19OCT2020 Neg/Neg/Neg Sore throat Pos/
C4591001 1095
10951238 (USA/63/F) Placebo Dose 2/19 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1095
10951260 (USA/25/M) Placebo Dose 2/9 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 110
FDA-CBER-2021-5683-0020290
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
New or increased
muscle pain
Sore throat
C4591001 1096
10961172 (USA/51/M) Placebo Dose 2/49 06NOV2020 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1096
10961258 (USA/55/F) Placebo Dose 2/25 22OCT2020 Neg/Neg/Neg New or increased
cough Pos/Pos
New or increased
muscle pain
Sore throat
C4591001 1098
10981062 (USA/63/F) Placebo Dose 2/32 17OCT2020 20OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1101
11011095 (USA/60/M) Placebo Dose 2/20 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1107
11071171 (USA/39/M) Placebo Dose 2/58 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
C4591001 1109
11091067 (USA/42/M) Placebo Dose 2/84 11NOV2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
Sore throat
C4591001 1109
11091092 (USA/18/M) Placebo Dose 2/70 31OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 111
FDA-CBER-2021-5683-0020291
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Sore throat
C4591001 1109
11091323 (USA/64/M) Placebo Dose 2/47 31OCT2020 02NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1109
11091416 (USA/46/F) Placebo Dose 2/41 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1109
11091448 (USA/46/F) Placebo Dose 2/9 06OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/ (R1 Pos)
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1109
11091482 (USA/63/M) Placebo Dose 2/28 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 112
FDA-CBER-2021-5683-0020292
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste or
smell
C4591001 1110
11101050 (USA/47/M) BNT162b2 (30
μg) Dose 2/76 10NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Sore throat
C4591001 1110
11101136 (USA/62/M) Placebo Dose 2/52 04NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Diarrhea
C4591001 1110
11101162 (USA/51/M) BNT162b2 (30
μg) Dose 2/34 24OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1111
11111010 (USA/75/M) Placebo Dose 2/45 04OCT2020 05OCT2020 Neg/Neg/Neg Fever Pos/
Chills
C4591001 1116
11161075 (USA/73/M) Placebo Dose 2/43 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
C4591001 1117
11171010 (USA/72/F) Placebo Dose 2/34 11OCT2020 19OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 113
FDA-CBER-2021-5683-0020293
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1118
11181088 (USA/73/M) Placebo Dose 2/36 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
C4591001 1120
11201115 (USA/19/F) Placebo Dose 2/73 06NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Sore throat
Diarrhea
C4591001 1121
11211105 (USA/52/M) Placebo Dose 2/39 05NOV2020 Neg/Unk/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1122
11221025 (USA/40/M) Placebo Dose 2/32 01NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1123
11231025 (USA/60/F) Placebo Dose 2/77 08NOV2020 Neg/Neg/Unk New or increased
cough Pos/
Sore throat
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 114
FDA-CBER-2021-5683-0020294
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1123
11231073 (USA/25/F) Placebo Dose 2/10 10SEP2020 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/Pos
Chills
New or increased
muscle pain
Sore throat
C4591001 1123
11231086 (USA/35/F) Placebo Dose 2/57 27OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
C4591001 1123
11231117 (USA/55/F) Placebo Dose 2/64 10NOV2020 Neg/Neg/Neg Chills Pos/
New or increased
muscle pain
C4591001 1123
11231214 (USA/60/F) Placebo Dose 2/34 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New loss of taste or
smell
Sore throat
C4591001 1123
11231234 (USA/29/M) Placebo Dose 2/32 02NOV2020 Unk/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 115
FDA-CBER-2021-5683-0020295
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1123
11231255 (USA/76/M) Placebo Dose 2/20 24OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1123
11231256 (USA/72/F) Placebo Dose 2/24 28OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1123
11231284 (USA/67/M) Placebo Dose 2/12 24OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1125
11251006 (USA/35/M) Placebo Dose 2/42 11OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
C4591001 1125
11251014 (USA/45/F) Placebo Dose 2/59 30OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 116
FDA-CBER-2021-5683-0020296
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Diarrhea
C4591001 1125
11251023 (USA/49/M) Placebo Dose 2/56 27OCT2020 Neg/Neg/Neg New or increased
cough Pos/
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/
Chills
New or increased
muscle pain
Sore throat
C4591001 1125
11251049 (USA/52/M) Placebo Dose 2/50 27OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Sore throat
C4591001 1125
11251109 (USA/46/F) Placebo Dose 2/51 04NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
Diarrhea
C4591001 1125
11251114 (USA/59/M) Placebo Dose 2/38 22OCT2020 Neg/Neg/Neg Fever Pos/Pos
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 117
FDA-CBER-2021-5683-0020297
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1125
11251124 (USA/39/M) Placebo Dose 2/53 08NOV2020 10NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
C4591001 1125
11251215 (USA/43/M) Placebo Dose 2/25 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1126
11261017 (USA/34/F) Placebo Dose 2/50 20OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1128
11281165 (USA/26/F) Placebo Dose 2/46 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1131
11311100 (USA/64/M) Placebo Dose 2/58 12NOV2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1131
11311138 (USA/45/F) Placebo Dose 2/45 07NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
C4591001 1133
11331209 (USA/30/M) Placebo Dose 2/32 10OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 118
FDA-CBER-2021-5683-0020298
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1134
11341022 (USA/66/M) Placebo Dose 2/29 29SEP2020 03OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1135
11351207 (USA/33/F) Placebo Dose 2/30 13OCT2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste or
smell
Diarrhea
C4591001 1141
11411088 (USA/52/M) Placebo Dose 2/29 07OCT2020 Neg/Neg/Neg Fever Pos/
Chills
Sore throat
C4591001 1141
11411161 (USA/25/F) Placebo Dose 2/47 08NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
Diarrhea
Vomiting
C4591001 1141
11411162 (USA/20/M) Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1149
11491113 (USA/69/M) BNT162b2 (30
μg) Dose 2/44 23OCT2020 24OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 119
FDA-CBER-2021-5683-0020299
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Chills
Vomiting
C4591001 1152
11521363 (USA/19/M) Placebo Dose 2/9 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1152
11521372 (USA/28/F) Placebo Dose 2/32 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1162
11621075 (USA/40/F) Placebo Dose 2/67 06NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
C4591001 1163
11631113 (USA/25/M) Placebo Dose 2/43 14OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
Sore throat
C4591001 1163
11631135 (USA/42/M) Placebo Dose 2/21 30SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Diarrhea
C4591001 1167
11671152 (USA/41/F) Placebo Dose 2/26 20OCT2020 Neg/Neg/Neg Fever Pos/Pos
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 120
FDA-CBER-2021-5683-0020300
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Diarrhea
C4591001 1167
11671157 (USA/58/M) Placebo Dose 2/16 14OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
C4591001 1168
11681004 (USA/54/M) Placebo Dose 2/67 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1168
11681007 (USA/33/F) Placebo Dose 2/36 06OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 121
FDA-CBER-2021-5683-0020301
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1168
11681008 (USA/37/M) Placebo Dose 2/35 05OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1168
11681114 (USA/46/F) Placebo Dose 2/23 13OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
Diarrhea
C4591001 1168
11681117 (USA/37/M) Placebo Dose 2/45 04NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1169
11691007 (USA/28/F) Placebo Dose 2/19 11OCT2020 Neg/Unk/Neg New or increased
shortness of breath Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 122
FDA-CBER-2021-5683-0020302
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New loss of taste or
smell
C4591001 1170
11701089 (USA/25/F) Placebo Dose 2/16 01OCT2020 Neg/Neg/Neg Fever Pos/
Sore throat
C4591001 1178
11781065 (USA/48/M) Placebo Dose 2/23 13OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1178
11781238 (USA/60/F) Placebo Dose 2/16 29OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
New or increased
muscle pain
Sore throat
C4591001 1178
11781280 (USA/58/M) Placebo Dose 2/9 03NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 123
FDA-CBER-2021-5683-0020303
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
Sore throat
C4591001 1179
11791085 (USA/34/M) Placebo Dose 2/34 09NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
C4591001 1223
12231005 (USA/20/F) Placebo Dose 2/51 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
Sore throat
C4591001 1223
12231096 (USA/77/F) Placebo Dose 2/48 11NOV2020 12NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1226
12261309 (BRA/61/M) Placebo Dose 2/40 20OCT2020 26OCT2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1226
12261363 (BRA/48/F) Placebo Dose 2/23 03OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 124
FDA-CBER-2021-5683-0020304
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Vomiting
C4591001 1226
12261599 (BRA/41/F) BNT162b2 (30
μg) Dose 2/36 06NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
Sore throat
C4591001 1226
12261624 (BRA/52/M) Placebo Dose 2/34 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
C4591001 1226
12261660 (BRA/27/F) Placebo Dose 2/37 05NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
C4591001 1226
12261964 (BRA/27/F) Placebo Dose 2/9 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 1226
12262111 (BRA/51/M) Placebo Dose 2/12 10NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 125
FDA-CBER-2021-5683-0020305
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12311043 (ARG/46/M) Placebo Dose 2/40 10OCT2020 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
C4591001 1231
12311267 (ARG/67/M) Placebo Dose 2/24 26SEP2020 07OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Sore throat
C4591001 1231
12311407 (ARG/63/M) Placebo Dose 2/24 27SEP2020 06OCT2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
Diarrhea
C4591001 1231
12311531 (ARG/35/M) Placebo Dose 2/9 16SEP2020 27SEP2020 Neg/Neg/Neg Fever Pos/
New or increased
shortness of breath
New or increased
muscle pain
C4591001 1231
12311556 (ARG/24/M) Placebo Dose 2/45 21OCT2020 09NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1231
12311560 (ARG/44/M) Placebo Dose 2/70 12NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 126
FDA-CBER-2021-5683-0020306
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
C4591001 1231
12311651 (ARG/52/F) Placebo Dose 2/8 14SEP2020 01OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
New or increased
muscle pain
Sore throat
Vomiting
C4591001 1231
12311664 (ARG/34/F) Placebo Dose 2/9 15SEP2020 03OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
C4591001 1231
12311754 (ARG/54/M) Placebo Dose 2/38 14OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12311764 (ARG/34/M) Placebo Dose 2/63 09NOV2020 09NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1231
12311982 (ARG/41/F) Placebo Dose 2/37 14OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12312479 (ARG/43/M) Placebo Dose 2/30 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
Chills
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 127
FDA-CBER-2021-5683-0020307
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste or
smell
C4591001 1231
12312507 (ARG/47/F) Placebo Dose 2/10 17SEP2020 28SEP2020 Neg/Neg/Neg New or increased
muscle pain Pos/
Sore throat
C4591001 1231
12312630 (ARG/39/F) Placebo Dose 2/44 23OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
New or increased
muscle pain
Sore throat
C4591001 1231
12312635 (ARG/71/M) Placebo Dose 2/27 04OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
Chills
Sore throat
C4591001 1231
12312867 (ARG/40/F) Placebo Dose 2/35 14OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/
New loss of taste or
smell
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 128
FDA-CBER-2021-5683-0020308
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Diarrhea
C4591001 1231
12312914 (ARG/50/M) Placebo Dose 2/43 26OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
muscle pain
Sore throat
C4591001 1231
12313182 (ARG/33/M) Placebo Dose 2/10 20SEP2020 19OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos/
New loss of taste or
smell
C4591001 1231
12313296 (ARG/49/F) Placebo Dose 2/25 04OCT2020 20OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1231
12313400 (ARG/46/M) Placebo Dose 2/37 19OCT2020 28OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
Chills
New or increased
muscle pain
Sore throat
C4591001 1231
12313422 (ARG/34/M) Placebo Dose 2/44 28OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 129
FDA-CBER-2021-5683-0020309
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
cough
New or increased
shortness of breath
Diarrhea
C4591001 1231
12313520 (ARG/28/F) Placebo Dose 2/8 22SEP2020 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
Sore throat
C4591001 1231
12313668 (ARG/33/M) Placebo Dose 2/12 24SEP2020 02OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Sore throat
C4591001 1231
12313787 (ARG/58/M) Placebo Dose 2/48 02NOV2020 05NOV2020 Neg/Neg/Neg New or increased
cough Pos/
Sore throat
C4591001 1231
12313895 (ARG/50/F) Placebo Dose 2/21 03OCT2020 17OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
New loss of taste or
smell
C4591001 1231
12314112 (ARG/52/M) Placebo Dose 2/42 28OCT2020 02NOV2020 Neg/Neg/Neg New or increased
cough Pos/
C4591001 1231
12314308 (ARG/31/F) Placebo Dose 2/15 30SEP2020 11OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 130
FDA-CBER-2021-5683-0020310
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
Sore throat
Vomiting
C4591001 1231
12314477 (ARG/36/M) Placebo Dose 2/16 03OCT2020 15OCT2020 Pos/Neg/Neg New or increased
cough Pos/
New loss of taste or
smell
C4591001 1231
12314534 (ARG/18/F) Placebo Dose 2/21 05OCT2020 09OCT2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
muscle pain
Sore throat
C4591001 1231
12314622 (ARG/32/F) Placebo Dose 2/15 01OCT2020 Neg/Neg/Neg Fever Pos/
New or increased
cough
New or increased
shortness of breath
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1231
12315636 (ARG/53/F) Placebo Dose 2/35 23OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 131
FDA-CBER-2021-5683-0020311
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
Sore throat
C4591001 1231
12315637 (ARG/40/F) Placebo Dose 2/11 29SEP2020 08OCT2020 Neg/Neg/Neg Fever Pos/
Chills
New or increased
muscle pain
New loss of taste or
smell
C4591001 1235
12351093 (USA/30/F) BNT162b2 (30
μg) Dose 2/32 08NOV2020 14NOV2020 Neg/Neg/Neg New loss of taste or
smell Pos/
C4591001 1241
12411885 (BRA/23/M) BNT162b2 (30
μg) Dose 2/14 22OCT2020 24OCT2020 Pos/Neg/Neg Sore throat Pos/Neg
C4591001 1241
12412017 (BRA/59/M) Placebo Dose 2/9 29OCT2020 Neg/Neg/Neg Fever Pos/Pos
New or increased
muscle pain
C4591001 1241
12412018 (BRA/55/F) Placebo Dose 2/8 28OCT2020 Neg/Neg/Neg Fever Pos/Pos
Sore throat
C4591001 1247
12471085 (ZAF/54/F) Placebo Dose 2/12 30OCT2020 03NOV2020 Neg/Unk/Neg New or increased
cough Pos/
Chills
Diarrhea
C4591001 1251
12511159 (USA/37/F) Placebo Dose 2/26 26OCT2020 29OCT2020 Neg/Neg/Neg New or increased
cough Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 132
FDA-CBER-2021-5683-0020312
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
muscle pain
New loss of taste or
smell
C4591001 4444
44441092 (ARG/64/M) Placebo Dose 2/23 03NOV2020 Neg/Neg/Neg New or increased
cough Pos/
New or increased
shortness of breath
New or increased
muscle pain
New loss of taste or
smell
Sore throat
C4591001 4444
44441144 (ARG/38/M) Placebo Dose 2/26 07NOV2020 Neg/Neg/Neg Fever Pos/
New or increased
muscle pain
New loss of taste or
smell
Diarrhea
C4591001 4444
44441204 (ARG/59/F) BNT162b2 (30
μg) Dose 2/21 02NOV2020 Neg/Neg/Neg New or increased
muscle pain Pos/
New loss of taste or
smell
C4591001 4444
44441224 (ARG/52/M) Placebo Dose 2/13 25OCT2020 Neg/Neg/Neg Fever Pos/
090177e1959af313\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 133
FDA-CBER-2021-5683-0020313
16.2.8.3 Listing of Subjects With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence
of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n
Subject
(Country /Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel Daya Start 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)
New or increased
shortness of breath
New or increased
muscle pain
C4591001 4444
44441563 (ARG/38/M) Placebo Dose 2/8 21OCT2020 Neg/Neg/Neg New loss of taste or
smell Pos/
Diarrhea
Abbreviations: ARG = Argentina; BRA = Brazil; NAAT = nucleic acid amplification test; N -binding = SARS -CoV -2 nucleoprotein –binding; Neg =
negative; Pos = positive; R1 = repeat central swab 1; SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; Un k = unknown; ZAF = South
Africa.
Note: HIV -positive subjects are included in this listing but not included in the analyses of the overall study objectives.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
b. SARS -CoV -2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS -CoV
…[truncated]