Document text
Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period – Evaluable Efficacy (7 Days) Population ......................................................... 2
Listing of Subjects and SARS -CoV -2 Variants With Multi ple COVID -19 Occurrence After Dose 1 – Dose 1 All -Available Efficacy Population ............... 260
Listing of Subjects and SARS -CoV -2 Variants With First Severe COVID -19 Occurrence Based on CDC -Defined or FDA -Defined Symptoms After Dose 1 –
Blinded Placebo -Controlled Follow -up Period – Dose 1 All -Available Efficacy Population ................................................................................................... 263
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650955
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1003 10031122
(USA/NEW YORK/48/M) Placebo Dose 2/77 05NOV2020 24NOV2020 Neg/Neg/Neg Fever Pos/Neg, 06NOV2020,
B.1.280
New or
increased
cough
Chills
C4591001 1003 10031167
(USA/NEW YORK/57/F) Placebo Dose 2/67 02NOV2020 11DEC2020 Neg/Neg/Neg New or
increased
cough Neg/, 06NOV2020, NS
New or
increased
shortness of
breath
Sore throat
Dose 2/112 17DEC2020 16JAN2021 Neg/Neg/Neg Fever Pos/Pos, 19DEC2020,
B.1.404
New or
increased
cough
New or
increased
shortness of
breath
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650956
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1003 10031204
(USA/NEW YORK/39/F) Placebo Dose 2/95 07DEC2020 12JAN2021 Neg/Neg/Neg New or
increased
cough Pos/Pos, 11DEC2020,
B.1.349
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1005 10051358
(USA/NEW YORK/52/F) Placebo Dose 2/59 10JAN2021 20JAN2021 Neg/Neg/Neg Fever Pos/, 12JAN2021,
B.1.243
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650957
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Sore throat
C4591001 1005 10051360
(USA/NEW YORK/77/M) Placebo Dose 2/29 10DEC2020 26DEC2020 Neg/Neg/Neg Fever Pos/, 12DEC2020,
B.1.243
New or
increased
cough
Sore throat
C4591001 1006 10061012
(USA/UTAH/53/M) Placebo Dose 2/68 06NOV2020 16NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 06NOV2020,
B.1.2
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650958
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1006 10061025
(USA/UTAH/65/F) Placebo Dose 2/82 21NOV2020 02DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 24NOV2020,
B.1.2
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1006 10061066
(USA/UTAH/39/F) Placebo Dose 2/59 11NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 11NOV2020,
B.1.2
Sore throat
C4591001 1006 10061075
(USA/UTAH/42/F) Placebo Dose 2/69 16NOV2020 04JAN2021 Neg/Neg/Neg New or
increased
muscle pain Pos/, 16NOV2020,
B.1.2
Sore throat
C4591001 1006 10061076
(USA/UTAH/61/F) Placebo Dose 2/123 11JAN2021 16JAN2021 Neg/Neg/Neg New or
increased Pos/, 12JAN2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650959
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
Sore throat
C4591001 1006 10061084
(USA/UTAH/27/F) Placebo Dose 2/48 27OCT2020 10NOV2020 Neg/Neg/Neg Fever Pos/, 28OCT2020,
B.1.2
New or
increased
cough
C4591001 1006 10061091
(USA/UTAH/20/F) Placebo Dose 2/50 30OCT2020 10NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 01NOV2020,
B.1.2
Sore throat
C4591001 1006 10061114
(USA/UTAH/21/M) Placebo Dose 2/35 20OCT2020 03NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 23OCT2020,
B.1.443
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650960
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1006 10061206
(USA/UTAH/12/M) Placebo Dose 2/10 01JAN2021 03JAN2021 Neg/Neg/Neg Fever Pos/, 01JAN2021,
B.1.400
C4591001 1006 10061260
(USA/UTAH/12/F) Placebo Dose 2/17 21JAN2021 27JAN2021 Neg/Neg/Neg Sore throat Pos/, 21JAN2021,
B.1.1.29
C4591001 1006 10061284
(USA/UTAH/14/M) Placebo Dose 2/8 15JAN2021 16JAN2021 Neg/Neg/Pos Diarrhea Pos/, 18JAN2021,
B.1.142
C4591001 1007 10071163
(USA/OHIO/80/F) Placebo Dose 2/76 14NOV2020 28NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 27NOV2020,
B.1.2
C4591001 1007 10071246
(USA/OHIO/30/F) Placebo Dose 2/129 16JAN2021 19JAN2021 Neg/Neg/Neg Sore throat Pos/, 19JAN2021, B.1.2
C4591001 1007 10071306
(USA/OHIO/58/F) Placebo Dose 2/60 31DEC2020 16JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 01JAN2021, B.1.2
New or
increased
shortness of
breath
Chills
Sore throat
Diarrhea
C4591001 1007 10071425
(USA/OHIO/50/F) Placebo Dose 2/25 06DEC2020 11DEC2020 Neg/Neg/Neg Sore throat Pos/, 11DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650961
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1007 10071448
(USA/OHIO/16/M) Placebo Dose 2/46 16JAN2021 24JAN2021 Neg/Neg/Neg Fever Pos/, 19JAN2021,
B.1.234
C4591001 1007 10071456
(USA/OHIO/17/F) Placebo Dose 2/35 10JAN2021 14JAN2021 Neg/Neg/Neg Sore throat Pos/, 13JAN2021,
B.1.240
C4591001 1007 10071527
(USA/OHIO/12/M) Placebo Dose 2/10 07JAN2021 10JAN2021 Neg/Neg/Pos Sore throat Pos/Pos, 10JAN2021,
B.1.2
C4591001 1007 10071559
(USA/OHIO/14/F) Placebo Dose 2/11 14JAN2021 26JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021, B.1.2
Sore throat
C4591001 1007 10071603
(USA/OHIO/13/M) Placebo Dose 2/35 22FEB2021 28FEB2021 Neg/Neg/Neg Fever Pos/, 23FEB2021, B.1.2
New loss of
taste or smell
Sore throat
C4591001 1008 10081011
(USA/MISSOURI/55/F) Placebo Dose 2/52 22OCT2020 31OCT2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 26OCT2020,
B.1.2
C4591001 1008 10081015
(USA/MISSOURI/33/M) Placebo Dose 2/97 07DEC2020 12DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 14DEC2020,
B.1.2
Sore throat
C4591001 1008 10081044
(USA/MISSOURI/58/F) Placebo Dose 2/66 12NOV2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650962
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
New or
increased
shortness of
breath
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1008 10081048
(USA/MISSOURI/38/F) Placebo Dose 2/60 07NOV2020 27NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 11NOV2020,
B.1.1.222
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650963
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1008 10081060
(USA/MISSOURI/71/F) Placebo Dose 2/78 25NOV2020 04DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 01DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1008 10081069
(USA/MISSOURI/57/F) Placebo Dose 2/97 15DEC2020 22DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 16DEC2020,
B.1.2
Sore throat
C4591001 1008 10081092
(USA/MISSOURI/62/F) Placebo Dose 2/76 29NOV2020 12DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020,
B.1.2
New or
increased
cough
Sore throat
Diarrhea
C4591001 1008 10081103
(USA/MISSOURI/35/F) Placebo Dose 2/86 10DEC2020 17DEC2020 Neg/Neg/Neg Fever Pos/, 17DEC2020,
B.1.1.304
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650964
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1008 10081123
(USA/MISSOURI/57/F) Placebo Dose 2/103 28DEC2020 22JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.2
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1008 10081130
(USA/MISSOURI/52/F) Placebo Dose 2/32 17OCT2020 29OCT2020 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 23OCT2020,
INDETERMINATE
C4591001 1008 10081145
(USA/MISSOURI/78/M) Placebo Dose 2/97 26DEC2020 31DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650965
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1008 10081153
(USA/MISSOURI/31/F) Placebo Dose 2/71 01DEC2020 04DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 02DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1008 10081210
(USA/MISSOURI/57/F) Placebo Dose 2/58 25NOV2020 13DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30NOV2020,
B.1.311
New or
increased
muscle pain
C4591001 1008 10081214
(USA/MISSOURI/62/M) Placebo Dose 2/42 09NOV2020 13NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020,
B.1.2
New or
increased
cough
New or
increased
shortness of
breath
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650966
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1008 10081232
(USA/MISSOURI/53/F) Placebo Dose 2/79 16DEC2020 27DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 18DEC2020,
B.1.311
Sore throat
C4591001 1008 10081281
(USA/MISSOURI/20/F) Placebo Dose 2/99 06JAN2021 19JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 08JAN2021, B.1.2
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1008 10081285
(USA/MISSOURI/60/F) Placebo Dose 2/57 27NOV2020 06DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 27NOV2020,
B.1.2
New or
increased
shortness of
breath
C4591001 1008 10081319
(USA/MISSOURI/79/F) Placebo Dose 2/31 04NOV2020 08NOV2020 Neg/Neg/Neg Chills Pos/, 06NOV2020,
B.1.509
C4591001 1008 10081356
(USA/MISSOURI/63/M) Placebo Dose 2/25 31OCT2020 10NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 04NOV2020,
B.1.311
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650967
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New loss of
taste or smell
C4591001 1008 10081415
(USA/MISSOURI/56/M) Placebo Dose 2/53 04DEC2020 14DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 07DEC2020,
B.1.2
C4591001 1008 10081493
(USA/MISSOURI/19/M) Placebo Dose 2/47 29NOV2020 04DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 01DEC2020,
B.1.428
Chills
New or
increased
muscle pain
C4591001 1008 10081563
(USA/MISSOURI/72/M) Placebo Dose 2/14 08NOV2020 20NOV2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 17NOV2020,
B.1.2
C4591001 1008 10081596
(USA/MISSOURI/38/F) Placebo Dose 2/61 02JAN2021 09JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021,
B.1.1.222
New or
increased
cough
Chills
C4591001 1008 10081612
(USA/MISSOURI/38/F) Placebo Dose 2/24 27NOV2020 05DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020,
B.1.1.7
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650968
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
C4591001 1008 10081664
(USA/MISSOURI/49/F) Placebo Dose 2/22 02DEC2020 14DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04DEC2020,
B.1.243
Sore throat
C4591001 1009 10091005
(USA/UTAH/31/M) Placebo Dose 2/66 06NOV2020 11NOV2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 03NOV2020,
B.1.2
C4591001 1009 10091018
(USA/UTAH/70/M) Placebo Dose 2/89 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1009 10091102
(USA/UTAH/22/F) Placebo Dose 2/115 08JAN2021 20JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 13JAN2021,
B.1.429
C4591001 1009 10091110
(USA/UTAH/46/F) Placebo Dose 2/69 21NOV2020 09DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 20NOV2020,
B.1.2
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650969
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1009 10091114
(USA/UTAH/77/F) Placebo Dose 2/105 27DEC2020 15JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 31DEC2020,
B.1.2
Diarrhea
C4591001 1009 10091115
(USA/UTAH/78/M) Placebo Dose 2/108 30DEC2020 17JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 04JAN2021, B.1.2
C4591001 1009 10091128
(USA/UTAH/51/M) Placebo Dose 2/30 15OCT2020 24FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 20OCT2020,
B.1.2
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1009 10091129
(USA/UTAH/38/M) BNT162b2 (30
μg) Dose 2/135 28JAN2021 Neg/Neg/Neg Fever Pos/, 08FEB2021,
B.1.427
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650970
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1009 10091153
(USA/UTAH/68/M) Placebo Dose 2/66 29NOV2020 06DEC2020 Unk/Neg/Neg New or
increased
cough Pos/, 01DEC2020,
B.1.1.161
Sore throat
C4591001 1009 10091208
(USA/UTAH/15/M) Placebo Dose 2/66 10JAN2021 14JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 10JAN2021, B.1.2
New or
increased
shortness of
breath
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650971
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
C4591001 1009 10091214
(USA/UTAH/47/F) Placebo Dose 2/24 27NOV2020 09DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 30NOV2020,
B.1.210
C4591001 1009 10091235
(USA/UTAH/16/M) Placebo Dose 2/17 27NOV2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30NOV2020,
B.1.2
Sore throat
Diarrhea
C4591001 1009 10091236
(USA/UTAH/45/F) Placebo Dose 2/16 26NOV2020 03DEC2020 Neg/Neg/Neg Sore throat Pos/, 30NOV2020, B.1
C4591001 1009 10091282
(USA/UTAH/14/M) Placebo Dose 2/42 01FEB2021 02FEB2021 Neg/Neg/Neg Chills Pos/, 02FEB2021,
B.1.427
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1009 10091412
(USA/UTAH/15/M) Placebo Dose 2/29 01MAR2021 Neg/Neg/Neg New or
increased
cough Pos/, 01MAR2021,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650972
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1012 10121006
(USA/ARIZONA/52/M) Placebo Dose 2/71 06NOV2020 23NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 15NOV2020,
B.1.2
C4591001 1012 10121042
(USA/ARIZONA/63/M) Placebo Dose 2/71 18NOV2020 Neg/Neg/Neg Fever Pos/, 23NOV2020,
B.1.2
New or
increased
cough
New loss of
taste or smell
Diarrhea
C4591001 1012 10121059
(USA/ARIZONA/28/F) Placebo Dose 2/95 13DEC2020 10FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 15DEC2020,
B.1.2
New or
increased
shortness of
breath
New loss of
taste or smell
Sore throat
C4591001 1012 10121164
(USA/ARIZONA/37/M) Placebo Dose 2/84 23DEC2020 02JAN2021 Neg/Neg/Neg Fever Pos/, 24DEC2020,
B.1.189
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650973
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Diarrhea
C4591001 1013 10131014
(USA/FLORIDA/29/M) Placebo Dose 2/131 29DEC2020 05JAN2021 Neg/Neg/Neg Fever Pos/, 05JAN2021,
B.1.234
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
Diarrhea
C4591001 1013 10131064
(USA/FLORIDA/28/F) Placebo Dose 2/155 25JAN2021 03FEB2021 Neg/Neg/Neg Fever Pos/, 28JAN2021, B.1
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650974
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
C4591001 1013 10131166
(USA/FLORIDA/50/M) Placebo Dose 2/117 28DEC2020 13JAN2021 Neg/Neg/Unk New or
increased
cough Pos/, 05JAN2021, B.1.2
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1013 10131167
(USA/FLORIDA/50/F) Placebo Dose 2/119 30DEC2020 13JAN2021 Neg/Neg/Neg Chills Pos/, 05JAN2021, B.1.2
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650975
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1013 10131257
(USA/FLORIDA/61/F) Placebo Dose 2/89 11DEC2020 30DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 13DEC2020,
B.1.2
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
Vomiting
C4591001 1013 10131288
(USA/FLORIDA/53/M) Placebo Dose 2/11 25SEP2020 06OCT2020 Neg/Neg/Neg New or
increased
cough Pos/, 28SEP2020,
B.1.396
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650976
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1013 10131296
(USA/FLORIDA/44/M) Placebo Dose 2/72 25NOV2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020,
B.1.1.122
New or
increased
cough
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1013 10131396
(USA/FLORIDA/41/M) Placebo Dose 2/75 05DEC2020 09DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 08DEC2020,
B.1.2
C4591001 1013 10131398
(USA/FLORIDA/36/M) Placebo Dose 2/86 16DEC2020 21DEC2020 Pos/Neg/Neg New or
increased
cough Pos/, 17DEC2020,
B.1.234
Chills
Sore throat
C4591001 1013 10131409
(USA/FLORIDA/35/M) Placebo Dose 2/90 21DEC2020 03JAN2021 Neg/Neg/Neg Fever Pos/, 30DEC2020, B.1
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650977
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
Sore throat
C4591001 1013 10131460
(USA/FLORIDA/56/F) BNT162b2 (30
μg) Dose 2/93 30DEC2020 27JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021,
B.1.1.222
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1013 10131471
(USA/FLORIDA/20/M) Placebo Dose 2/46 13NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 17NOV2020,
B.1.280
Chills
New or
increased
muscle pain
C4591001 1013 10131475
(USA/FLORIDA/49/F) Placebo Dose 2/23 22OCT2020 25OCT2020 Neg/Neg/Neg New or
increased
cough Pos/, 26OCT2020,
B.1.369
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650978
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
C4591001 1013 10131539
(USA/FLORIDA/70/F) Placebo Dose 2/94 07JAN2021 17JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 08JAN2021, B.1.2
Sore throat
C4591001 1013 10131540
(USA/FLORIDA/71/M) Placebo Dose 2/91 04JAN2021 06JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021, B.1.2
Chills
C4591001 1013 10131720
(USA/FLORIDA/55/M) BNT162b2 (30
μg) Dose 2/93 05FEB2021 03MAR2021 Neg/Neg/Neg New or
increased
cough Pos/, 09FEB2021, A.2.4
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650979
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Vomiting
C4591001 1013 10131758
(USA/FLORIDA/60/M) Placebo Dose 2/48 28DEC2020 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 30DEC2020,
B.1.1.222
Chills
New or
increased
muscle pain
C4591001 1015 10151094
(USA/MASSACHUSETTS/50/F) Placebo Dose 2/123 14JAN2021 Neg/Neg/Neg Fever Pos/, 19JAN2021, B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1016 10161003
(USA/KENTUCKY/23/F) Placebo Dose 2/57 14OCT2020 26OCT2020 Neg/Neg/Neg Fever Pos/, 16OCT2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650980
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
New loss of
taste or smell
C4591001 1016 10161004
(USA/KENTUCKY/51/F) BNT162b2 (30
μg) Dose 2/58 15OCT2020 22OCT2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 17OCT2020,
B.1.2
Sore throat
C4591001 1016 10161017
(USA/KENTUCKY/18/F) Placebo Dose 2/19 07SEP2020 29OCT2020 Neg/Neg/Neg Fever Pos/, 09SEP2020,
B.1.1.4
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1016 10161035
(USA/KENTUCKY/70/F) Placebo Dose 2/67 29OCT2020 29OCT2020 Neg/Neg/Neg New or
increased
cough Pos/, 30OCT2020,
B.1.2
C4591001 1016 10161048
(USA/KENTUCKY/52/F) Placebo Dose 2/75 06NOV2020 31JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 06NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650981
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1016 10161114
(USA/KENTUCKY/22/F) BNT162b2 (30
μg) Dose 2/122 02JAN2021 08JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021, B.1.2
New or
increased
muscle pain
C4591001 1016 10161123
(USA/KENTUCKY/48/F) Placebo Dose 2/98 09DEC2020 25DEC2020 Neg/Neg/Neg Fever Pos/, 11DEC2020,
B.1.2
Chills
C4591001 1016 10161146
(USA/KENTUCKY/59/F) Placebo Dose 2/89 07DEC2020 20DEC2020 Neg/Neg/Neg Fever Pos/, 10DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650982
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1016 10161183
(USA/KENTUCKY/31/F) Placebo Dose 2/32 16OCT2020 01NOV2020 Neg/Neg/Neg Fever Pos/ (R1 Pos),
16OCT2020
(23OCT2020), B.1.2
(B.1.2)
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
Vomiting
C4591001 1016 10161207
(USA/KENTUCKY/62/F) Placebo Dose 2/27 14OCT2020 01NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 16OCT2020,
B.1.2
Chills
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650983
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1016 10161209
(USA/KENTUCKY/33/F) Placebo Dose 2/98 28DEC2020 05JAN2021 Neg/Neg/Neg New or
increased
muscle pain Pos/, 04JAN2021, B.1.2
C4591001 1016 10161305
(USA/KENTUCKY/16/M) Placebo Dose 2/8 09NOV2020 13NOV2020 Neg/Neg/Pos New or
increased
cough Pos/, 11NOV2020,
QNS
New loss of
taste or smell
C4591001 1016 10161317
(USA/KENTUCKY/17/M) Placebo Dose 2/51 26DEC2020 03JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 29DEC2020,
B.1.2
New or
increased
muscle pain
C4591001 1018 10181083
(USA/TEXAS/45/M) Placebo Dose 2/72 06NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 15NOV2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650984
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Diarrhea
Vomiting
C4591001 1018 10181107
(USA/TEXAS/26/F) BNT162b2 (30
μg) Dose 2/125 02JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 05JAN2021, B.1.2
New loss of
taste or smell
C4591001 1018 10181198
(USA/TEXAS/50/F) Placebo Dose 2/55 04NOV2020 05NOV2020 Neg/Neg/Neg Fever Pos/, 05NOV2020,
B.1.234
New or
increased
cough
C4591001 1018 10181289
(USA/TEXAS/49/M) Placebo Dose 2/88 31DEC2020 13JAN2021 Neg/Neg/Neg Fever Pos/, 03JAN2021, B.1.2
New or
increased
cough
New or
increased
muscle pain
C4591001 1019 10191038
(USA/TEXAS/47/F) Placebo Dose 2/61 03NOV2020 18NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650985
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
New loss of
taste or smell
Diarrhea
C4591001 1019 10191184
(USA/TEXAS/52/M) Placebo Dose 2/36 05NOV2020 08DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 05NOV2020,
B.1.2
New or
increased
muscle pain
Vomiting
C4591001 1019 10191200
(USA/TEXAS/67/M) Placebo Dose 2/77 22DEC2020 19JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 28DEC2020,
B.1.2
C4591001 1019 10191242
(USA/TEXAS/28/F) Placebo Dose 2/70 29DEC2020 05JAN2021 Neg/Neg/Neg Fever Pos/, 31DEC2020,
B.1.2
New or
increased
cough
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650986
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1019 10191251
(USA/TEXAS/19/M) Placebo Dose 2/45 06DEC2020 16DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 10DEC2020, B.1
New loss of
taste or smell
C4591001 1019 10191256
(USA/TEXAS/49/M) Placebo Dose 2/41 08DEC2020 15DEC2020 Neg/Neg/Neg Fever Pos/, 11DEC2020,
B.1.403
New or
increased
cough
Chills
Sore throat
C4591001 1021 10211093
(USA/NORTH CAROLINA/72/M) Placebo Dose 2/99 21DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 10JAN2021,
B.1.1.244
C4591001 1021 10211122
(USA/NORTH CAROLINA/57/F) Placebo Dose 2/114 12JAN2021 12FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 14JAN2021, B.1.2
Sore throat
C4591001 1022 10221053
(USA/WASHINGTON/64/F) Placebo Dose 2/112 03JAN2021 10JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021, B.1.2
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650987
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Vomiting
C4591001 1024 10241080
(USA/NEW JERSEY/54/M) Placebo Dose 2/142 03FEB2021 21FEB2021 Neg/Neg/Neg Chills Pos/, 04FEB2021, A.2.4
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1024 10241092
(USA/NEW JERSEY/53/F) Placebo Dose 2/86 10DEC2020 13DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 11DEC2020,
B.1.509
C4591001 1027 10271086
(USA/NORTH CAROLINA/46/F) Placebo Dose 2/77 03DEC2020 18DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 07DEC2020, B.1
Sore throat
C4591001 1027 10271202
(USA/NORTH CAROLINA/57/F) Placebo Dose 2/68 19DEC2020 01JAN2021 Neg/Neg/Neg New or
increased
cough Pos/Pos, 21DEC2020,
B.1.1.139
New or
increased
muscle pain
C4591001 1028 10281038
(USA/NORTH DAKOTA/53/F) Placebo Dose 2/31 10OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/, 13OCT2020, B.1
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650988
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Sore throat
C4591001 1028 10281054
(USA/NORTH DAKOTA/51/M) Placebo Dose 2/63 16NOV2020 18DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 20NOV2020,
B.1.2
Chills
C4591001 1028 10281057
(USA/NORTH DAKOTA/63/M) Placebo Dose 2/93 29DEC2020 08JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1028 10281100
(USA/NORTH DAKOTA/47/F) Placebo Dose 2/19 11OCT2020 21OCT2020 Neg/Neg/Neg New or
increased
cough Pos/, 13OCT2020,
B.1.240
C4591001 1028 10281122
(USA/NORTH DAKOTA/44/F) Placebo Dose 2/53 15NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 18NOV2020,
B.1.2
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650989
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Vomiting
C4591001 1028 10281132
(USA/NORTH DAKOTA/61/M) Placebo Dose 2/14 11OCT2020 21OCT2020 Neg/Neg/Neg Fever Pos/, 13OCT2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
C4591001 1028 10281138
(USA/NORTH DAKOTA/38/F) Placebo Dose 2/25 23OCT2020 03NOV2020 Neg/Neg/Neg Fever Pos/, 27OCT2020,
B.1.400
Chills
Sore throat
Diarrhea
C4591001 1028 10281152
(USA/NORTH DAKOTA/51/M) Placebo Dose 2/94 30DEC2020 06JAN2021 Neg/Neg/Neg Fever Pos/, 02JAN2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650990
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
C4591001 1028 10281187
(USA/NORTH DAKOTA/82/M) Placebo Dose 2/59 09DEC2020 30DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 09DEC2020, B.1
C4591001 1028 10281269
(USA/NORTH DAKOTA/29/F) Placebo Dose 2/9 19NOV2020 24NOV2020 Neg/Neg/Neg Fever Pos/, 19NOV2020, B.1
New or
increased
cough
New or
increased
muscle pain
Sore throat
C4591001 1030 10301025
(USA/OHIO/66/F) Placebo Dose 2/85 15DEC2020 24DEC2020 Neg/Neg/Neg Sore throat Pos/, 16DEC2020,
B.1.2
C4591001 1030 10301048
(USA/OHIO/33/M) Placebo Dose 2/74 05DEC2020 11DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 06DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650991
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1030 10301069
(USA/OHIO/29/F) Placebo Dose 2/64 04DEC2020 10DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 05DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1030 10301088
(USA/OHIO/39/F) Placebo Dose 2/87 30DEC2020 12JAN2021 Neg/Neg/Neg Fever Pos/, 02JAN2021, B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
C4591001 1030 10301113
(USA/OHIO/30/F) Placebo Dose 2/35 12NOV2020 17NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 19NOV2020,
B.1.2
New loss of
taste or smell
Diarrhea
C4591001 1030 10301123
(USA/OHIO/45/F) Placebo Dose 2/64 15DEC2020 30DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 21DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650992
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1036 10361035
(USA/TENNESSEE/63/M) BNT162b2 (30
μg) Dose 2/71 24NOV2020 29NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 01DEC2020,
B.1.265
New loss of
taste or smell
Diarrhea
C4591001 1037 10371004
(USA/TENNESSEE/57/F) Placebo Dose 2/69 16NOV2020 03FEB2021 Neg/Neg/Neg Chills Pos/, 19NOV2020,
B.1.2
C4591001 1037 10371016
(USA/TENNESSEE/84/M) Placebo Dose 2/88 05DEC2020 11DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 10DEC2020,
B.1.2
New or
increased
muscle pain
C4591001 1037 10371036
(USA/TENNESSEE/62/M) Placebo Dose 2/52 31OCT2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 05NOV2020,
B.1.361
New or
increased
cough
Chills
C4591001 1037 10371113
(USA/TENNESSEE/71/F) Placebo Dose 2/70 29NOV2020 09DEC2020 Neg/Neg/Neg Fever Pos/, 02DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650993
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
C4591001 1037 10371146
(USA/TENNESSEE/78/M) Placebo Dose 2/96 27DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.2
New or
increased
shortness of
breath
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1037 10371155
(USA/TENNESSEE/55/M) Placebo Dose 2/75 12DEC2020 Unk/Neg/Neg Fever Pos/, 14DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650994
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New loss of
taste or smell
Sore throat
C4591001 1037 10371187
(USA/TENNESSEE/78/M) Placebo Dose 2/69 06DEC2020 14DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 14DEC2020,
B.1.2
Chills
C4591001 1037 10371193
(USA/TENNESSEE/76/F) Placebo Dose 2/36 05NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 17NOV2020,
B.1.234
New or
increased
shortness of
breath
Chills
Diarrhea
C4591001 1037 10371200
(USA/TENNESSEE/29/F) Placebo Dose 2/70 15DEC2020 27DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 16DEC2020,
B.1.2
New or
increased
shortness of
breath
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650995
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1037 10371280
(USA/TENNESSEE/58/M) Placebo Dose 2/28 10NOV2020 04DEC2020 Neg/Neg/Neg Fever Pos/, 11NOV2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Diarrhea
C4591001 1037 10371307
(USA/TENNESSEE/43/F) Placebo Dose 2/59 16DEC2020 25DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 18DEC2020,
B.1.2
New or
increased
muscle pain
C4591001 1037 10371323
(USA/TENNESSEE/48/F) Placebo Dose 2/36 02DEC2020 06DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 02DEC2020,
B.1.2
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650996
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1037 10371353
(USA/TENNESSEE/37/M) Placebo Dose 2/18 28NOV2020 21DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020,
B.1.1.231
New or
increased
cough
New or
increased
shortness of
breath
Chills
New loss of
taste or smell
Diarrhea
C4591001 1038 10381044
(USA/TENNESSEE/32/F) Placebo Dose 2/79 02DEC2020 13DEC2020 Pos/Neg/Neg New or
increased
shortness of
breath Pos/, 07DEC2020,
INDETERMINATE
Chills
C4591001 1038 10381051
(USA/TENNESSEE/69/M) Placebo Dose 2/51 07NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020,
B.1.361
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650997
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Sore throat
C4591001 1039 10391025
(USA/TEXAS/55/F) Placebo Dose 2/40 25OCT2020 15NOV2020 Neg/Neg/Neg Sore throat Pos/, 28OCT2020,
B.1.2
C4591001 1039 10391268
(USA/TEXAS/13/F) Placebo Dose 2/33 29JAN2021 03MAR2021 Neg/Neg/Neg Fever Pos/, 29JAN2021, B.1
New or
increased
cough
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
C4591001 1042 10421133
(USA/TEXAS/61/F) Placebo Dose 2/142 28JAN2021 11FEB2021 Neg/Neg/Neg Fever Pos/, 01FEB2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650998
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1042 10421168
(USA/TEXAS/59/F) Placebo Dose 2/76 30NOV2020 21DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 02DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1042 10421223
(USA/TEXAS/71/F) Placebo Dose 2/90 27DEC2020 16JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0650999
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1044 10441138
(USA/VIRGINIA/63/M) Placebo Dose 2/102 22JAN2021 23JAN2021 Neg/Neg/Neg Fever Pos/, 25JAN2021,
B.1.351
C4591001 1044 10441167
(USA/VIRGINIA/42/F) Placebo Dose 2/103 05FEB2021 25FEB2021 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 09FEB2021, B.1.2
New loss of
taste or smell
C4591001 1044 10441242
(USA/VIRGINIA/17/M) Placebo Dose 2/49 01FEB2021 07FEB2021 Neg/Neg/Neg Fever Pos/, 04FEB2021, B.1.2
Chills
New or
increased
muscle pain
C4591001 1044 10441374
(USA/VIRGINIA/15/M) Placebo Dose 2/13 14FEB2021 17FEB2021 Neg/Neg/Neg Chills Pos/, 16FEB2021,
B.1.243
New loss of
taste or smell
Vomiting
C4591001 1046 10461037
(USA/ALABAMA/60/M) BNT162b2 (30
μg) Dose 2/109 21DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 22DEC2020, B.1
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651000
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1046 10461058
(USA/ALABAMA/44/F) Placebo Dose 2/62 09NOV2020 16NOV2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 09NOV2020,
B.1.240
C4591001 1046 10461101
(USA/ALABAMA/31/F) Placebo Dose 2/98 21DEC2020 24DEC2020 Neg/Neg/Neg Fever Pos/, 21DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
C4591001 1046 10461124
(USA/ALABAMA/36/F) Placebo Dose 2/105 29DEC2020 04JAN2021 Neg/Neg/Neg Fever Pos/, 29DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651001
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1046 10461203
(USA/ALABAMA/55/F) Placebo Dose 2/53 23NOV2020 30NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 24NOV2020,
B.1.2
New or
increased
muscle pain
C4591001 1046 10461204
(USA/ALABAMA/54/M) Placebo Dose 2/55 23NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 24NOV2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
C4591001 1046 10461235
(USA/ALABAMA/59/M) BNT162b2 (30
μg) Dose 2/86 23DEC2020 29DEC2020 Neg/Neg/Neg Fever Pos/, 23DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
C4591001 1046 10461334
(USA/ALABAMA/53/F) Placebo Dose 2/28 16DEC2020 17DEC2020 Neg/Neg/Neg Fever Pos/, 16DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651002
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1047 10471024
(USA/ALABAMA/63/F) BNT162b2 (30
μg) Dose 2/37 16OCT2020 18OCT2020 Neg/Neg/Neg Fever Pos/, 17OCT2020,
B.1.139
Diarrhea
Vomiting
C4591001 1047 10471079
(USA/ALABAMA/21/F) Placebo Dose 2/87 13DEC2020 25DEC2020 Neg/Neg/Neg Fever Pos/, 15DEC2020,
B.1.2
Sore throat
C4591001 1047 10471080
(USA/ALABAMA/43/F) Placebo Dose 2/56 12NOV2020 20NOV2020 Neg/Neg/Neg New loss of
taste or smell Pos/Pos, 13NOV2020,
B.1.2
C4591001 1047 10471170
(USA/ALABAMA/63/M) BNT162b2 (30
μg) Dose 2/62 01DEC2020 15JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 03DEC2020, QNS
C4591001 1047 10471217
(USA/ALABAMA/49/F) Placebo Dose 2/72 19DEC2020 22DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 22DEC2020,
B.1.240
C4591001 1047 10471327
(USA/ALABAMA/35/M) Placebo Dose 2/59 09JAN2021 13JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021,
B.1.366
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651003
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1048 10481027
(USA/ARIZONA/46/M) Placebo Dose 2/112 05JAN2021 19JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 11JAN2021, B.1.2
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1048 10481064
(USA/ARIZONA/52/F) Placebo Dose 2/107 06JAN2021 10JAN2021 Neg/Neg/Neg Fever Pos/, 08JAN2021, B.1.2
New or
increased
cough
New or
increased
muscle pain
C4591001 1048 10481104
(USA/ARIZONA/57/F) Placebo Dose 2/43 11NOV2020 16DEC2020 Neg/Neg/Neg Fever Pos/, 13NOV2020,
B.1.2
Chills
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651004
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1048 10481118
(USA/ARIZONA/67/F) Placebo Dose 2/32 02NOV2020 11NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 13NOV2020,
B.1.2
New loss of
taste or smell
Sore throat
C4591001 1052 10521082
(USA/CALIFORNIA/38/F) Placebo Dose 2/110 09JAN2021 10JAN2021 Neg/Neg/Neg Fever Pos/, 12JAN2021,
B.1.429
C4591001 1052 10521110
(USA/CALIFORNIA/53/F) Placebo Dose 2/112 13JAN2021 13JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 13JAN2021, B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1054 10541001
(USA/CALIFORNIA/50/F) Placebo Dose 2/134 19JAN2021 09FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 24JAN2021,
B.1.409
New or
increased
shortness of
breath
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651005
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
New loss of
taste or smell
Vomiting
C4591001 1054 10541002
(USA/CALIFORNIA/51/M) BNT162b2 (30
μg) Dose 2/134 19JAN2021 25JAN2021 Neg/Neg/Neg Fever Pos/, 26JAN2021,
B.1.409
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1054 10541035
(USA/CALIFORNIA/29/M) BNT162b2 (30
μg) Dose 2/81 29NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 04DEC2020,
B.1.1.29
New or
increased
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651006
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1054 10541038
(USA/CALIFORNIA/27/F) Placebo Dose 2/88 10DEC2020 04FEB2021 Neg/Neg/Neg Fever Pos/, 12DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1054 10541137
(USA/CALIFORNIA/42/M) Placebo Dose 2/100 07JAN2021 13JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 08JAN2021, B.1.2
C4591001 1054 10541146
(USA/CALIFORNIA/65/F) BNT162b2 (30
μg) Dose 2/62 09DEC2020 12DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 11DEC2020,
B.1.399
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651007
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1054 10541194
(USA/CALIFORNIA/58/F) Placebo Dose 2/29 03DEC2020 17DEC2020 Neg/Neg/Neg Sore throat Pos/ (R1 Pos),
05DEC2020
(04JAN2021), B.1.2
(B.1.525)
C4591001 1054 10541202
(USA/CALIFORNIA/57/M) Placebo Dose 2/60 11JAN2021 Neg/Neg/Neg Fever Pos/, 12JAN2021,
INDETERMINATE
New or
increased
cough
New or
increased
shortness of
breath
New or
increased
muscle pain
C4591001 1055 10551016
(USA/CALIFORNIA/38/F) BNT162b2 (30
μg) Dose 2/104 12DEC2020 18DEC2020 Neg/Neg/Neg Sore throat Pos/, 16DEC2020,
B.1.241
C4591001 1055 10551099
(USA/CALIFORNIA/30/M) Placebo Dose 2/100 22DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 27DEC2020,
B.1.429
New loss of
taste or smell
C4591001 1055 10551123
(USA/CALIFORNIA/67/M) Placebo Dose 2/64 19NOV2020 29NOV2020 Neg/Neg/Neg Fever Pos/, 20NOV2020, B.1
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651008
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
C4591001 1055 10551203
(USA/CALIFORNIA/49/M) Placebo Dose 2/48 17NOV2020 27NOV2020 Neg/Neg/Neg New or
increased
cough Pos/Pos, 18NOV2020,
B.1.2
Chills
New or
increased
muscle pain
C4591001 1055 10551228
(USA/CALIFORNIA/39/F) Placebo Dose 2/48 21NOV2020 14DEC2020 Neg/Neg/Neg Fever Pos/, 22NOV2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651009
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1055 10551243
(USA/CALIFORNIA/18/M) Placebo Dose 2/67 20DEC2020 29DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 22DEC2020,
B.1.2
Chills
New or
increased
muscle pain
Sore throat
C4591001 1056 10561041
(USA/FLORIDA/49/F) BNT162b2 (30
μg) Dose 2/116 10JAN2021 01FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 15JAN2021,
B.1.1.143
New loss of
taste or smell
C4591001 1056 10561349
(USA/FLORIDA/59/F) Placebo Dose 2/72 05JAN2021 13JAN2021 Neg/Neg/Neg Fever Pos/, 11JAN2021,
B.1.375
New or
increased
cough
New or
increased
shortness of
breath
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651010
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1056 10561502
(USA/FLORIDA/64/F) Placebo Dose 2/65 05JAN2021 17JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 07JAN2021, B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1056 10561514
(USA/FLORIDA/30/F) Placebo Dose 2/9 13NOV2020 18NOV2020 Neg/Neg/Neg Diarrhea Pos/, 17NOV2020,
B.1.2
C4591001 1057 10571238
(USA/FLORIDA/49/F) Placebo Dose 2/60 13DEC2020 21DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 15DEC2020,
B.1.2
New loss of
taste or smell
Sore throat
C4591001 1057 10571363
(USA/FLORIDA/17/F) Placebo Dose 2/48 24JAN2021 01FEB2021 Neg/Neg/Neg Fever Pos/, 26JAN2021, B.1.2
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651011
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
C4591001 1066 10661050
(USA/IDAHO/59/M) Placebo Dose 2/116 03JAN2021 18JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021, B.1
Chills
New or
increased
muscle pain
Sore throat
C4591001 1066 10661129
(USA/IDAHO/44/F) Placebo Dose 2/73 28NOV2020 21DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 30NOV2020,
B.1.2
C4591001 1066 10661163
(USA/IDAHO/24/M) Placebo Dose 2/56 16NOV2020 28NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 18NOV2020,
B.1.2
New loss of
taste or smell
C4591001 1066 10661167
(USA/IDAHO/50/F) Placebo Dose 2/81 12DEC2020 05JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 17DEC2020,
B.1.2
C4591001 1066 10661176
(USA/IDAHO/61/M) Placebo Dose 2/99 31DEC2020 03JAN2021 Neg/Neg/Neg Fever Pos/, 05JAN2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651012
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1066 10661242
(USA/IDAHO/54/M) Placebo Dose 2/90 30DEC2020 08JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021, B.1.2
New or
increased
muscle pain
C4591001 1066 10661313
(USA/IDAHO/66/F) Placebo Dose 2/34 17NOV2020 28NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 19NOV2020,
B.1.2
Chills
New or
increased
muscle pain
C4591001 1068 10681003
(USA/MONTANA/42/F) Placebo Dose 2/108 25DEC2020 11JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 31DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1068 10681037
(USA/MONTANA/22/F) Placebo Dose 2/116 07JAN2021 09JAN2021 Neg/Neg/Neg Sore throat Pos/Pos, 12JAN2021,
B.1.2
C4591001 1068 10681082
(USA/MONTANA/58/M) Placebo Dose 2/42 01NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 02NOV2020,
B.1.395
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651013
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
New or
increased
shortness of
breath
Sore throat
C4591001 1068 10681083
(USA/MONTANA/26/F) Placebo Dose 2/105 03JAN2021 08JAN2021 Neg/Neg/Neg New or
increased
cough Pos/Pos, 06JAN2021,
B.1.2
C4591001 1068 10681110
(USA/MONTANA/30/F) Placebo Dose 2/22 16OCT2020 02NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 21OCT2020,
B.1.2
New loss of
taste or smell
C4591001 1068 10681115
(USA/MONTANA/28/M) Placebo Dose 2/93 31DEC2020 08JAN2021 Neg/Neg/Neg Sore throat Pos/Pos, 04JAN2021,
B.1.2
C4591001 1071 10711022
(USA/NEBRASKA/47/M) Placebo Dose 2/72 10NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 11NOV2020,
B.1.139
Chills
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651014
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1071 10711028
(USA/NEBRASKA/54/F) Placebo Dose 2/93 03DEC2020 09DEC2020 Neg/Neg/Neg Fever Pos/, 11DEC2020,
B.1.311
New or
increased
cough
New loss of
taste or smell
C4591001 1071 10711034
(USA/NEBRASKA/49/F) Placebo Dose 2/111 20DEC2020 27DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 24DEC2020,
B.1.234
New loss of
taste or smell
C4591001 1071 10711058
(USA/NEBRASKA/72/F) Placebo Dose 2/60 06NOV2020 25NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 07NOV2020,
B.1.2
Sore throat
C4591001 1071 10711147
(USA/NEBRASKA/70/M) Placebo Dose 2/86 22DEC2020 24DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 27DEC2020,
B.1.2
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651015
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1071 10711197
(USA/NEBRASKA/61/M) Placebo Dose 2/31 13NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020,
B.1.2
Chills
C4591001 1071 10711198
(USA/NEBRASKA/54/F) Placebo Dose 2/31 13NOV2020 15NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020,
B.1.2
New or
increased
cough
C4591001 1071 10711249
(USA/NEBRASKA/44/M) Placebo Dose 2/59 15JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 19JAN2021, B.1.2
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1072 10721004
(USA/ALABAMA/59/M) Placebo Dose 2/129 15JAN2021 12FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 20JAN2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651016
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1072 10721024
(USA/ALABAMA/51/F) BNT162b2 (30
μg) Dose 2/137 25JAN2021 Neg/Neg/Neg New or
increased
cough Pos/Pos, 26JAN2021,
B.1.2
C4591001 1072 10721057
(USA/ALABAMA/70/M) Placebo Dose 2/41 26OCT2020 16NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 05NOV2020,
B.1.2
C4591001 1072 10721064
(USA/ALABAMA/77/M) Placebo Dose 2/85 09DEC2020 26DEC2020 Neg/Neg/Neg Fever Pos/Pos, 15DEC2020,
B.1.2
New or
increased
cough
C4591001 1072 10721089
(USA/ALABAMA/19/F) Placebo Dose 2/157 26FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 01MAR2021,
B.1.1.7
C4591001 1072 10721096
(USA/ALABAMA/70/M) Placebo Dose 2/93 31DEC2020 05FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 01JAN2021, B.1
Sore throat
C4591001 1073 10731029
(USA/ARIZONA/43/F) Placebo Dose 2/104 07DEC2020 11DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 09DEC2020,
B.1.2
C4591001 1073 10731036
(USA/ARIZONA/50/F) Placebo Dose 2/82 17NOV2020 02DEC2020 Neg/Neg/Neg Fever Pos/, 19NOV2020,
B.1.234
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651017
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New loss of
taste or smell
Sore throat
C4591001 1073 10731060
(USA/ARIZONA/78/F) Placebo Dose 2/127 04JAN2021 10JAN2021 Neg/Neg/Neg Fever Pos/, 07JAN2021,
B.1.243
New or
increased
cough
New or
increased
muscle pain
C4591001 1073 10731067
(USA/ARIZONA/24/F) Placebo Dose 2/127 06JAN2021 09JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 08JAN2021, B.1
New or
increased
muscle pain
C4591001 1073 10731068
(USA/ARIZONA/39/M) Placebo Dose 2/126 05JAN2021 08JAN2021 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 06JAN2021, B.1
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651018
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1073 10731085
(USA/ARIZONA/51/F) Placebo Dose 2/105 14DEC2020 16DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 16DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1073 10731093
(USA/ARIZONA/48/F) BNT162b2 (30
μg) Dose 2/77 24NOV2020 05DEC2020 Neg/Neg/Neg Chills Pos/, 27NOV2020,
B.1.2
New or
increased
muscle pain
C4591001 1073 10731098
(USA/ARIZONA/70/M) Placebo Dose 2/100 16DEC2020 20DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 17DEC2020,
B.1.2
C4591001 1073 10731103
(USA/ARIZONA/49/M) Placebo Dose 2/133 18JAN2021 22JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 20JAN2021, B.1.2
New loss of
taste or smell
C4591001 1073 10731123
(USA/ARIZONA/73/F) Placebo Dose 2/69 22NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 25NOV2020,
B.1.2
Sore throat
C4591001 1073 10731124
(USA/ARIZONA/76/M) Placebo Dose 2/67 20NOV2020 25NOV2020 Neg/Neg/Neg Fever Pos/, 25NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651019
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
C4591001 1077 10771175
(USA/NEW YORK/61/M) Placebo Dose 2/85 15DEC2020 05JAN2021 Neg/Neg/Neg Fever Pos/, 21DEC2020,
B.1.240
New or
increased
cough
Chills
New loss of
taste or smell
C4591001 1077 10771176
(USA/NEW YORK/61/F) BNT162b2 (30
μg) Dose 2/90 20DEC2020 03JAN2021 Neg/Neg/Neg Fever Pos/, 21DEC2020,
B.1.240
New or
increased
cough
C4591001 1077 10771189
(USA/NEW YORK/51/M) Placebo Dose 2/51 11NOV2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 15NOV2020,
B.1.110.3
Diarrhea
C4591001 1077 10771195
(USA/NEW YORK/73/F) Placebo Dose 2/40 01NOV2020 29NOV2020 Neg/Neg/Neg Fever Pos/, 07NOV2020,
B.1.110.3
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651020
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
New or
increased
muscle pain
C4591001 1077 10771239
(USA/NEW YORK/59/M) Placebo Dose 2/58 04DEC2020 07DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020,
B.1.404
New or
increased
cough
New or
increased
muscle pain
C4591001 1079 10791046
(USA/NORTH CAROLINA/55/F) Placebo Dose 2/62 26OCT2020 17DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 30OCT2020, B.1
C4591001 1079 10791054
(USA/NORTH CAROLINA/28/F) Placebo Dose 2/63 29OCT2020 14NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 30OCT2020,
B.1.1.29
C4591001 1079 10791098
(USA/NORTH CAROLINA/53/M) Placebo Dose 2/111 22DEC2020 04JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 07JAN2021, B.47
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651021
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1079 10791123
(USA/NORTH CAROLINA/61/F) Placebo Dose 2/135 13JAN2021 18JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 22JAN2021, B.1.2
New or
increased
muscle pain
C4591001 1079 10791230
(USA/NORTH CAROLINA/19/M) Placebo Dose 2/83 13DEC2020 20DEC2020 Neg/Pos/Neg New or
increased
cough Pos/, 18DEC2020,
B.1.1.244
New or
increased
muscle pain
Sore throat
C4591001 1079 10791255
(USA/NORTH CAROLINA/58/M) Placebo Dose 2/96 01JAN2021 03JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021, B.1.2
Chills
C4591001 1079 10791257
(USA/NORTH CAROLINA/45/M) Placebo Dose 2/98 05JAN2021 08FEB2021 Neg/Neg/Neg Fever Pos/, 06JAN2021, B.1.2
New or
increased
cough
New or
increased
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651022
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
Chills
New or
increased
muscle pain
Diarrhea
C4591001 1079 10791296
(USA/NORTH CAROLINA/40/F) Placebo Dose 2/29 26NOV2020 10DEC2020 Neg/Neg/Neg New or
increased
cough Pos/Pos, 01DEC2020,
B.1.2
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1080 10801135
(USA/FLORIDA/28/M) Placebo Dose 2/126 28JAN2021 17FEB2021 Neg/Neg/Neg Fever Pos/, 11FEB2021, QNS
New or
increased
cough
New or
increased
shortness of
breath
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651023
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1081 10811014
(USA/OHIO/63/M) Placebo Dose 2/103 12DEC2020 20FEB2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 15DEC2020,
B.1.2
C4591001 1081 10811043
(USA/OHIO/58/F) Placebo Dose 2/90 06DEC2020 21DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 08DEC2020,
B.1.2
C4591001 1081 10811077
(USA/OHIO/50/F) Placebo Dose 2/132 19JAN2021 02FEB2021 Neg/Neg/Neg Fever Pos/, 23JAN2021,
B.1.1.222
New or
increased
cough
Chills
C4591001 1081 10811086
(USA/OHIO/45/F) Placebo Dose 2/117 09JAN2021 05FEB2021 Neg/Neg/Neg Fever Pos/, 14JAN2021,
B.1.438
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651024
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1081 10811151
(USA/OHIO/79/F) Placebo Dose 2/10 30SEP2020 14OCT2020 Neg/Neg/Neg New or
increased
cough Pos/, 14OCT2020, QNS
C4591001 1081 10811173
(USA/OHIO/66/M) Placebo Dose 2/99 31DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04JAN2021, B.1.2
Diarrhea
C4591001 1081 10811196
(USA/OHIO/48/F) Placebo Dose 2/90 29DEC2020 26JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 31DEC2020,
B.1.2
New loss of
taste or smell
Sore throat
C4591001 1081 10811210
(USA/OHIO/51/M) BNT162b2 (30
μg) Dose 2/85 31DEC2020 21JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/ (R1 Pos),
02JAN2021
(03JAN2021), B.1.2
(B.1.2)
C4591001 1082 10821016
(USA/TENNESSEE/46/F) Placebo Dose 2/44 06OCT2020 27OCT2020 Neg/Neg/Neg Fever Pos/, 07OCT2020,
B.1.400
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651025
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1082 10821026
(USA/TENNESSEE/48/M) Placebo Dose 2/81 13NOV2020 24DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 18NOV2020,
B.1.2
C4591001 1082 10821143
(USA/TENNESSEE/41/M) Placebo Dose 2/48 11NOV2020 05DEC2020 Neg/Neg/Neg Fever Pos/, 13NOV2020, B.1
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
C4591001 1082 10821162
(USA/TENNESSEE/72/M) Placebo Dose 2/50 27NOV2020 23DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651026
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Chills
C4591001 1083 10831181
(USA/TEXAS/35/F) Placebo Dose 2/99 28DEC2020 03JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.2
New or
increased
shortness of
breath
New loss of
taste or smell
C4591001 1084 10841016
(USA/TEXAS/43/M) Placebo Dose 2/130 31DEC2020 05JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 07JAN2021, B.1.2
Sore throat
C4591001 1084 10841089
(USA/TEXAS/28/M) Placebo Dose 2/85 20NOV2020 02DEC2020 Neg/Neg/Neg Fever Pos/, 24NOV2020,
B.1.2
New or
increased
cough
C4591001 1084 10841188
(USA/TEXAS/48/F) Placebo Dose 2/83 25NOV2020 07DEC2020 Neg/Neg/Neg Fever Pos/, 30NOV2020,
B.1.2
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651027
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Vomiting
C4591001 1084 10841302
(USA/TEXAS/65/F) Placebo Dose 2/56 12NOV2020 30NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 16NOV2020,
B.1.2
New or
increased
shortness of
breath
C4591001 1084 10841392
(USA/TEXAS/72/F) Placebo Dose 2/80 25DEC2020 27DEC2020 Neg/Neg/Neg Fever Pos/, 29DEC2020,
B.1.2
New or
increased
cough
Chills
New loss of
taste or smell
C4591001 1085 10851004
(USA/TEXAS/49/F) Placebo Dose 2/120 17DEC2020 18DEC2020 Neg/Neg/Neg Sore throat Pos/, 18DEC2020,
B.1.509
C4591001 1085 10851027
(USA/TEXAS/50/F) Placebo Dose 2/101 02DEC2020 25FEB2021 Neg/Neg/Neg New or
increased Pos/, 04DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651028
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
New or
increased
muscle pain
C4591001 1085 10851177
(USA/TEXAS/70/M) Placebo Dose 2/107 01JAN2021 05JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 05JAN2021, B.1.2
C4591001 1085 10851258
(USA/TEXAS/58/M) Placebo Dose 2/100 30DEC2020 03JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021, B.1.2
C4591001 1085 10851293
(USA/TEXAS/63/F) Placebo Dose 2/37 07NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020,
INDETERMINATE
New or
increased
cough
New loss of
taste or smell
C4591001 1085 10851347
(USA/TEXAS/77/F) Placebo Dose 2/75 22DEC2020 29DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 29DEC2020,
B.1.2
C4591001 1085 10851374
(USA/TEXAS/17/F) Placebo Dose 2/48 03JAN2021 07JAN2021 Neg/Neg/Neg Chills Pos/, 04JAN2021, NS
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651029
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1087 10871572
(USA/NORTH CAROLINA/54/M) Placebo Dose 2/88 31JAN2021 15FEB2021 Neg/Neg/Neg Fever Pos/, 01FEB2021,
B.1.243
New or
increased
cough
New or
increased
muscle pain
C4591001 1088 10881011
(USA/NORTH CAROLINA/48/F) Placebo Dose 2/89 27NOV2020 19DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1088 10881016
(USA/NORTH CAROLINA/50/F) Placebo Dose 2/119 28DEC2020 02JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 29DEC2020,
B.1.2
C4591001 1088 10881024
(USA/NORTH CAROLINA/32/F) Placebo Dose 2/96 06DEC2020 20DEC2020 Neg/Neg/Neg Fever Pos/, 09DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651030
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Chills
Sore throat
C4591001 1088 10881075
(USA/NORTH CAROLINA/68/F) Placebo Dose 2/83 02DEC2020 13DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 07DEC2020,
B.1.2
C4591001 1088 10881086
(USA/NORTH CAROLINA/69/F) Placebo Dose 2/106 28DEC2020 04JAN2021 Neg/Neg/Neg Fever Pos/, 29DEC2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
Sore throat
C4591001 1088 10881091
(USA/NORTH CAROLINA/66/F) Placebo Dose 2/132 25JAN2021 03MAR2021 Neg/Neg/Unk Fever Pos/, 28JAN2021,
B.1.243
Chills
C4591001 1088 10881097
(USA/NORTH CAROLINA/57/M) Placebo Dose 2/83 07DEC2020 17DEC2020 Neg/Neg/Neg Fever Pos/, 08DEC2020,
B.1.2
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651031
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1088 10881126
(USA/NORTH CAROLINA/65/M) Placebo Dose 2/68 29NOV2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30NOV2020,
B.1.2
C4591001 1088 10881142
(USA/NORTH CAROLINA/61/F) Placebo Dose 2/94 25DEC2020 29DEC2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 29DEC2020,
B.1.2
C4591001 1088 10881148
(USA/NORTH CAROLINA/28/F) Placebo Dose 2/73 04DEC2020 10DEC2020 Neg/Neg/Neg Fever Pos/, 09DEC2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651032
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1088 10881164
(USA/NORTH CAROLINA/58/F) Placebo Dose 2/46 13NOV2020 03DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 18NOV2020,
B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1088 10881188
(USA/NORTH CAROLINA/67/F) Placebo Dose 2/84 21DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 23DEC2020,
B.1.2
New or
increased
muscle pain
C4591001 1088 10881219
(USA/NORTH CAROLINA/63/M) Placebo Dose 2/17 25OCT2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 26OCT2020,
B.1.2
New or
increased
cough
New or
increased
muscle pain
C4591001 1088 10881233
(USA/NORTH CAROLINA/47/M) Placebo Dose 2/15 02NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/, 04NOV2020, B.1
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651033
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
Sore throat
C4591001 1089 10891100
(USA/NORTH CAROLINA/33/F) Placebo Dose 2/115 24DEC2020 05FEB2021 Neg/Neg/Neg Fever Pos/, 28DEC2020,
B.1.361
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1089 10891110
(USA/NORTH CAROLINA/59/F) Placebo Dose 2/158 04FEB2021 20FEB2021 Neg/Neg/Neg Fever Pos/, 11FEB2021, B.1.2
New or
increased
cough
Diarrhea
Vomiting
C4591001 1089 10891115
(USA/NORTH CAROLINA/55/M) BNT162b2 (30
μg) Dose 2/140 21JAN2021 25FEB2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 26JAN2021,
B.1.210
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651034
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1089 10891235
(USA/NORTH CAROLINA/29/F) Placebo Dose 2/47 08NOV2020 18NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 12NOV2020,
B.1.2
Sore throat
C4591001 1089 10891314
(USA/NORTH CAROLINA/57/F) Placebo Dose 2/56 30NOV2020 11DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30NOV2020,
B.1.2
Sore throat
Diarrhea
C4591001 1090 10901022
(USA/NORTH CAROLINA/52/F) BNT162b2 (30
μg) Dose 2/114 19DEC2020 07JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 31DEC2020,
B.1.1.222
C4591001 1090 10901075
(USA/NORTH CAROLINA/73/M) Placebo Dose 2/96 01DEC2020 18DEC2020 Neg/Neg/Neg Diarrhea Pos/, 21DEC2020,
B.1.2
C4591001 1090 10901086
(USA/NORTH CAROLINA/55/M) Placebo Dose 2/165 08FEB2021 Neg/Neg/Neg New or
increased
muscle pain Pos/, 10FEB2021,
B.1.429
C4591001 1090 10901121
(USA/NORTH CAROLINA/58/F) Placebo Dose 2/49 18OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos/, 20OCT2020,
B.1.369
New loss of
taste or smell
C4591001 1090 10901278
(USA/NORTH CAROLINA/46/M) Placebo Dose 2/81 10DEC2020 22DEC2020 Neg/Neg/Neg Fever Pos/, 14DEC2020,
B.1.239
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651035
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Diarrhea
C4591001 1090 10901349
(USA/NORTH CAROLINA/53/M) Placebo Dose 2/105 11JAN2021 16JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 12JAN2021,
B.1.1.244
C4591001 1090 10901353
(USA/NORTH CAROLINA/63/M) Placebo Dose 2/40 08NOV2020 29NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020,
B.1.349
New or
increased
cough
C4591001 1090 10901528
(USA/NORTH CAROLINA/53/F) Placebo Dose 2/43 24DEC2020 24JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 28DEC2020,
B.1.2
C4591001 1091 10911003
(USA/OHIO/59/M) Placebo Dose 2/135 01JAN2021 10JAN2021 Neg/Neg/Neg New or
increased
muscle pain Pos/, 14JAN2021, B.1
C4591001 1091 10911071
(USA/OHIO/66/F) Placebo Dose 2/164 10FEB2021 27FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 18FEB2021, B.1.2
Chills
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651036
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1091 10911119
(USA/OHIO/44/F) Placebo Dose 2/121 31DEC2020 21JAN2021 Neg/Neg/Neg Sore throat Pos/Pos, 05JAN2021,
B.1.2
C4591001 1091 10911183
(USA/OHIO/26/M) Placebo Dose 2/62 17NOV2020 26NOV2020 Neg/Neg/Neg Fever Pos/, 18NOV2020,
B.1.1.253
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1091 10911198
(USA/OHIO/34/M) Placebo Dose 2/93 17DEC2020 30DEC2020 Neg/Neg/Neg Fever Pos/, 18DEC2020,
B.1.400
New or
increased
cough
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651037
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New loss of
taste or smell
C4591001 1091 10911203
(USA/43/M) Placebo Dose 2/44 05NOV2020 Neg/Neg/Neg New or
increased
cough Unk/Pos, 05NOV2020,
NS
New or
increased
muscle pain
C4591001 1091 10911327
(USA/OHIO/40/F) Placebo Dose 2/38 18NOV2020 25NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 20NOV2020,
B.1.2
New or
increased
shortness of
breath
New loss of
taste or smell
C4591001 1091 10911365
(USA/OHIO/73/F) Placebo Dose 2/50 24DEC2020 07JAN2021 Neg/Neg/Neg Fever Pos/, 26DEC2020,
B.1.2
New or
increased
cough
Sore throat
Diarrhea
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651038
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1091 10911371
(USA/OHIO/31/M) Placebo Dose 2/14 24NOV2020 09DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 26NOV2020,
B.1.2
New or
increased
muscle pain
C4591001 1091 10911404
(USA/OHIO/13/F) Placebo Dose 2/27 23JAN2021 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 25JAN2021,
B.1.361
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1092 10921021
(USA/OHIO/60/F) Placebo Dose 2/48 27OCT2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 29OCT2020,
B.1.2
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651039
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1092 10921055
(USA/OHIO/19/F) Placebo Dose 2/88 10DEC2020 20DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 14DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1092 10921079
(USA/OHIO/67/M) Placebo Dose 2/122 15JAN2021 04FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 03FEB2021, NS
C4591001 1092 10921089
(USA/OHIO/63/F) BNT162b2 (30
μg) Dose 2/101 25DEC2020 01JAN2021 Neg/Neg/Neg Chills Pos/, 27DEC2020,
B.1.2
C4591001 1092 10921092
(USA/OHIO/66/M) Placebo Dose 2/66 21NOV2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 25NOV2020,
B.1.2
New or
increased
cough
New or
increased
shortness of
breath
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651040
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
Vomiting
C4591001 1092 10921130
(USA/OHIO/53/M) Placebo Dose 2/18 09OCT2020 Neg/Neg/Neg Fever Pos/, 12OCT2020,
B.1.2
New or
increased
cough
New or
increased
shortness of
breath
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1092 10921176
(USA/OHIO/68/M) Placebo Dose 2/86 24DEC2020 17JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020,
B.1.2
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651041
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New loss of
taste or smell
C4591001 1092 10921242
(USA/OHIO/69/M) Placebo Dose 2/9 12NOV2020 10JAN2021 Neg/Neg/Neg New or
increased
cough Pos/ (R1 Pos),
17NOV2020
(01DEC2020), B.1.2
(B.1)
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1092 10921258
(USA/OHIO/60/F) Placebo Dose 2/52 01JAN2021 14JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021, B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
C4591001 1093 10931019
(USA/IOWA/28/M) Placebo Dose 2/87 03DEC2020 12DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04DEC2020,
B.1.234
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651042
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Chills
New loss of
taste or smell
Sore throat
Diarrhea
Vomiting
C4591001 1093 10931028
(USA/IOWA/38/M) Placebo Dose 2/69 17NOV2020 23NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 18NOV2020,
B.1.240
Sore throat
C4591001 1093 10931081
(USA/IOWA/67/F) Placebo Dose 2/19 05OCT2020 19OCT2020 Neg/Neg/Neg Sore throat Pos/, 06OCT2020,
B.1.2
C4591001 1093 10931121
(USA/IOWA/37/F) Placebo Dose 2/50 23NOV2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30NOV2020,
B.1.234
Chills
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651043
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1093 10931177
(USA/IOWA/55/F) Placebo Dose 2/15 23NOV2020 27NOV2020 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 30NOV2020,
B.1.234
Chills
New or
increased
muscle pain
C4591001 1093 10931189
(USA/IOWA/74/M) Placebo Dose 2/26 04DEC2020 15DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020,
B.1.240
New or
increased
cough
Chills
New or
increased
muscle pain
C4591001 1093 10931216
(USA/IOWA/35/M) Placebo Dose 2/11 30NOV2020 02DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 02DEC2020, B.1
C4591001 1094 10941056
(USA/TEXAS/58/F) Placebo Dose 2/68 21NOV2020 22DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 25NOV2020, NS
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651044
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1094 10941163
(USA/TEXAS/53/F) Placebo Dose 2/61 19DEC2020 19JAN2021 Neg/Neg/Neg Sore throat Pos/, 22DEC2020,
B.1.2
C4591001 1094 10941171
(USA/TEXAS/71/M) Placebo Dose 2/60 25DEC2020 12JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 28DEC2020,
B.1.2
C4591001 1095 10951002
(USA/TEXAS/20/F) Placebo Dose 2/140 07JAN2021 08JAN2021 Neg/Neg/Neg Fever Pos/, 11JAN2021, B.1.2
Chills
C4591001 1095 10951060
(USA/TEXAS/36/M) Placebo Dose 2/104 08DEC2020 07JAN2021 Neg/Neg/Neg Fever Pos/, 09DEC2020,
B.1.2
New or
increased
cough
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Diarrhea
Vomiting
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651045
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1095 10951098
(USA/TEXAS/59/F) Placebo Dose 2/71 06NOV2020 17DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 10NOV2020,
B.1.2
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1095 10951117
(USA/TEXAS/70/M) Placebo Dose 2/96 15DEC2020 02JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 19DEC2020, B.1
C4591001 1095 10951196
(USA/TEXAS/50/M) Placebo Dose 2/88 18DEC2020 21DEC2020 Neg/Neg/Neg Fever Pos/, 21DEC2020, NS
New or
increased
cough
C4591001 1095 10951223
(USA/TEXAS/42/M) Placebo Dose 2/95 27DEC2020 01JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.243
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651046
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1095 10951238
(USA/TEXAS/63/F) Placebo Dose 2/19 02NOV2020 20DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 09NOV2020,
B.1.2
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1095 10951260
(USA/TEXAS/25/M) Placebo Dose 2/9 05NOV2020 05NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 09NOV2020, B.1
Chills
New or
increased
muscle pain
Sore throat
C4591001 1096 10961021
(USA/TEXAS/67/F) Placebo Dose 2/98 08DEC2020 09JAN2021 Neg/Neg/Neg Chills Pos/, 18DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651047
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1096 10961072
(USA/TEXAS/49/M) Placebo Dose 2/98 22DEC2020 08JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 28DEC2020,
INDETERMINATE
Chills
C4591001 1096 10961164
(USA/TEXAS/62/F) BNT162b2 (30
μg) Dose 2/104 29DEC2020 25JAN2021 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 05JAN2021, B.1.2
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1096 10961172
(USA/TEXAS/51/M) Placebo Dose 2/49 06NOV2020 08NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020,
B.1.361
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651048
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1096 10961258
(USA/TEXAS/55/F) Placebo Dose 2/25 22OCT2020 26OCT2020 Neg/Neg/Neg New or
increased
cough Pos/Pos, 26OCT2020,
B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1097 10971038
(USA/SOUTH CAROLINA/64/M) Placebo Dose 2/79 04DEC2020 15DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 08DEC2020,
B.1.110.3
Sore throat
C4591001 1098 10981028
(USA/TEXAS/58/M) Placebo Dose 2/102 21DEC2020 02JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 22DEC2020,
B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1098 10981046
(USA/TEXAS/66/F) BNT162b2 (30
μg) Dose 2/70 23NOV2020 23NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 25NOV2020,
B.1.1.29
C4591001 1098 10981058
(USA/TEXAS/69/F) Placebo Dose 2/130 23JAN2021 06FEB2021 Neg/Neg/Neg Fever Pos/, 04FEB2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651049
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1098 10981062
(USA/TEXAS/63/F) Placebo Dose 2/32 17OCT2020 20OCT2020 Neg/Neg/Neg New or
increased
muscle pain Pos/, 19OCT2020,
B.1.2
C4591001 1098 10981187
(USA/TEXAS/23/M) Placebo Dose 2/124 07FEB2021 18FEB2021 Neg/Neg/Neg Fever Pos/, 10FEB2021,
B.1.429
Chills
New or
increased
muscle pain
Sore throat
C4591001 1098 10981216
(USA/TEXAS/52/M) Placebo Dose 2/42 23NOV2020 29NOV2020 Neg/Neg/Neg Sore throat Pos/, 25NOV2020,
B.1.2
C4591001 1101 11011041
(USA/NEBRASKA/54/F) Placebo Dose 2/107 15JAN2021 21JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 19JAN2021, B.1.2
C4591001 1101 11011095
(USA/NEBRASKA/60/M) Placebo Dose 2/20 02NOV2020 06NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 04NOV2020,
B.1.2
C4591001 1101 11011105
(USA/NEBRASKA/22/F) Placebo Dose 2/18 19NOV2020 27NOV2020 Neg/Neg/Neg Fever Pos/, 24NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651050
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1107 11071037
(USA/ALABAMA/59/M) Placebo Dose 2/124 26DEC2020 29JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 03JAN2021, B.1.2
New or
increased
muscle pain
C4591001 1107 11071121
(USA/ALABAMA/77/M) Placebo Dose 2/98 14DEC2020 30DEC2020 Neg/Neg/Neg Chills Pos/, 27DEC2020,
B.1.2
C4591001 1107 11071170
(USA/ALABAMA/61/F) Placebo Dose 2/101 23DEC2020 02JAN2021 Neg/Neg/Neg Sore throat Pos/, 27DEC2020,
B.1.349
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651051
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1107 11071171
(USA/ALABAMA/39/M) Placebo Dose 2/58 10NOV2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 11NOV2020, B.1
Chills
C4591001 1107 11071190
(USA/ALABAMA/42/F) Placebo Dose 2/82 13DEC2020 28DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 14DEC2020,
B.1.234
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1109 11091067
(USA/FLORIDA/42/M) Placebo Dose 2/84 11NOV2020 28NOV2020 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 11NOV2020,
B.1.311
Sore throat
C4591001 1109 11091092
(USA/FLORIDA/18/M) Placebo Dose 2/70 31OCT2020 24NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020,
B.1.240
New or
increased
cough
Sore throat
C4591001 1109 11091147
(USA/FLORIDA/46/F) Placebo Dose 2/151 20JAN2021 26JAN2021 Neg/Neg/Neg Sore throat Pos/, 22JAN2021,
B.1.306
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651052
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1109 11091229
(USA/FLORIDA/69/F) Placebo Dose 2/82 26NOV2020 12JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 28NOV2020,
B.1.2
C4591001 1109 11091233
(USA/FLORIDA/59/F) BNT162b2 (30
μg) Dose 2/115 26DEC2020 28DEC2020 Neg/Neg/Neg Sore throat Pos/, 29DEC2020,
B.1.311
C4591001 1109 11091309
(USA/FLORIDA/24/F) Placebo Dose 2/124 11JAN2021 21JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 15JAN2021, B.1
New or
increased
shortness of
breath
New loss of
taste or smell
C4591001 1109 11091316
(USA/FLORIDA/47/M) Placebo Dose 2/115 05JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 08JAN2021, B.1.2
New or
increased
shortness of
breath
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651053
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1109 11091323
(USA/FLORIDA/64/M) Placebo Dose 2/47 31OCT2020 02NOV2020 Neg/Neg/Neg Fever Pos/, 03NOV2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
C4591001 1109 11091346
(USA/FLORIDA/64/M) Placebo Dose 2/99 24DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04JAN2021,
INDETERMINATE
New loss of
taste or smell
C4591001 1109 11091415
(USA/FLORIDA/48/F) Placebo Dose 2/93 27DEC2020 18JAN2021 Neg/Neg/Neg Fever Pos/, 29DEC2020,
B.1.2
New or
increased
cough
New or
increased
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651054
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
Chills
Sore throat
C4591001 1109 11091416
(USA/FLORIDA/46/F) Placebo Dose 2/41 03NOV2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 11NOV2020,
B.1.2
New or
increased
cough
Sore throat
C4591001 1109 11091448
(USA/FLORIDA/46/F) Placebo Dose 2/9 06OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos/ (R1 Pos),
09OCT2020
(23OCT2020), B.1.2
(B.1.2)
New or
increased
cough
New or
increased
shortness of
breath
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651055
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1109 11091482
(USA/FLORIDA/63/M) Placebo Dose 2/28 29OCT2020 13NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 03NOV2020,
B.1.369
New loss of
taste or smell
C4591001 1110 11101050
(USA/FLORIDA/47/M) BNT162b2 (30
μg) Dose 2/76 10NOV2020 12JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 12NOV2020,
B.1.2
Chills
Sore throat
C4591001 1110 11101079
(USA/FLORIDA/71/F) Placebo Dose 2/88 28NOV2020 13DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04DEC2020,
B.1.2
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1110 11101108
(USA/FLORIDA/58/M) Placebo Dose 2/95 11DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 15DEC2020,
B.1.1.143
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651056
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1110 11101111
(USA/FLORIDA/45/M) Placebo Dose 2/108 25DEC2020 06JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 02JAN2021, B.1.2
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
Diarrhea
C4591001 1110 11101136
(USA/FLORIDA/62/M) Placebo Dose 2/52 04NOV2020 15JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 06NOV2020, B.1
Chills
Diarrhea
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651057
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1110 11101162
(USA/FLORIDA/51/M) BNT162b2 (30
μg) Dose 2/34 24OCT2020 04NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 26OCT2020,
B.1.2
New loss of
taste or smell
C4591001 1110 11101232
(USA/FLORIDA/62/M) BNT162b2 (30
μg) Dose 2/113 21JAN2021 15FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 22JAN2021, B.1.2
New loss of
taste or smell
C4591001 1110 11101325
(USA/FLORIDA/42/F) Placebo Dose 2/75 04JAN2021 26JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 07JAN2021, B.1.2
New or
increased
muscle pain
C4591001 1111 11111010
(USA/FLORIDA/75/M) Placebo Dose 2/45 04OCT2020 05OCT2020 Neg/Neg/Neg Fever Pos/, 06OCT2020,
B.1.2
Chills
C4591001 1111 11111128
(USA/FLORIDA/60/F) Placebo Dose 2/127 12JAN2021 19JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021, B.1.2
New or
increased
muscle pain
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651058
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1111 11111150
(USA/FLORIDA/57/M) Placebo Dose 2/43 02NOV2020 17NOV2020 Neg/Neg/Neg Chills Pos/, 17NOV2020,
B.1.311
New or
increased
muscle pain
C4591001 1111 11111186
(USA/FLORIDA/88/M) Placebo Dose 2/79 29DEC2020 05JAN2021 Neg/Neg/Neg Sore throat Pos/, 05JAN2021, B.1.2
Diarrhea
C4591001 1112 11121003
(USA/GEORGIA/64/F) Placebo Dose 2/116 12DEC2020 28DEC2020 Neg/Neg/Neg Fever Pos/, 15DEC2020,
B.1.1.222
New or
increased
cough
Sore throat
Diarrhea
C4591001 1112 11121064
(USA/GEORGIA/42/M) Placebo Dose 2/131 02JAN2021 18JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 06JAN2021, B.1.2
Diarrhea
C4591001 1112 11121210
(USA/GEORGIA/69/F) Placebo Dose 2/88 21DEC2020 06JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 21DEC2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651059
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1112 11121224
(USA/GEORGIA/45/F) Placebo Dose 2/76 07DEC2020 28DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 15DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1112 11121245
(USA/GEORGIA/41/F) Placebo Dose 2/91 30DEC2020 02JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 04JAN2021, B.1.2
Chills
C4591001 1112 11121301
(USA/GEORGIA/47/M) Placebo Dose 2/27 28NOV2020 19DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 29NOV2020,
B.1.280
Chills
New or
increased
muscle pain
Sore throat
C4591001 1114 11141008
(USA/KANSAS/22/M) Placebo Dose 2/80 19NOV2020 23NOV2020 Neg/Neg/Neg Fever Pos/, 20NOV2020,
B.1.2
C4591001 1114 11141014
(USA/KANSAS/20/F) BNT162b2 (30
μg) Dose 2/123 01JAN2021 21JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 06JAN2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651060
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1114 11141024
(USA/KANSAS/18/F) Placebo Dose 2/126 07JAN2021 31JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 11JAN2021, B.1.2
C4591001 1114 11141075
(USA/KANSAS/40/F) Placebo Dose 2/110 28DEC2020 16FEB2021 Neg/Neg/Neg Fever Pos/, 04JAN2021, QNS
New or
increased
cough
New or
increased
shortness of
breath
New or
increased
muscle pain
C4591001 1116 11161072
(USA/MISSISSIPPI/52/F) Placebo Dose 2/81 10DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 14DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1116 11161075
(USA/MISSISSIPPI/73/M) Placebo Dose 2/43 03NOV2020 19JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 05NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651061
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Chills
C4591001 1116 11161104
(USA/MISSISSIPPI/38/F) Placebo Dose 2/140 07FEB2021 01MAR2021 Neg/Neg/Neg New or
increased
cough Pos/, 09FEB2021, B.1.2
C4591001 1116 11161111
(USA/MISSISSIPPI/71/F) Placebo Dose 2/111 12JAN2021 04FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 21JAN2021,
INDETERMINATE
C4591001 1116 11161160
(USA/MISSISSIPPI/47/M) Placebo Dose 2/103 08JAN2021 18JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 13JAN2021, B.1.2
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1116 11161184
(USA/MISSISSIPPI/77/M) Placebo Dose 2/72 09DEC2020 24DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 15DEC2020,
B.1.2
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651062
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1116 11161207
(USA/MISSISSIPPI/58/F) Placebo Dose 2/64 02DEC2020 25DEC2020 Neg/Neg/Neg Fever Pos/, 03DEC2020,
B.1.243
New or
increased
cough
Chills
New or
increased
muscle pain
C4591001 1116 11161224
(USA/MISSISSIPPI/52/F) Placebo Dose 2/46 14NOV2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 16NOV2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651063
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1116 11161250
(USA/MISSISSIPPI/62/F) Placebo Dose 2/55 01DEC2020 11DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 03DEC2020,
B.1.234
Chills
New or
increased
muscle pain
Sore throat
C4591001 1116 11161275
(USA/MISSISSIPPI/58/F) Placebo Dose 2/80 01JAN2021 09JAN2021 Neg/Neg/Neg Fever Pos/, 03JAN2021,
B.1.234
Chills
Diarrhea
C4591001 1116 11161283
(USA/MISSISSIPPI/72/F) Placebo Dose 2/39 20NOV2020 02DEC2020 Neg/Neg/Neg Sore throat Pos/, 02DEC2020,
B.1.361
C4591001 1117 11171010
(USA/MISSOURI/72/F) Placebo Dose 2/34 11OCT2020 19OCT2020 Neg/Neg/Neg Fever Pos/, 11OCT2020,
B.1.2
New or
increased
cough
C4591001 1117 11171028
(USA/MISSOURI/67/M) Placebo Dose 2/62 10NOV2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 13NOV2020,
B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651064
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1117 11171031
(USA/MISSOURI/74/F) Placebo Dose 2/82 29NOV2020 07DEC2020 Neg/Neg/Neg Sore throat Pos/, 05DEC2020,
B.1.2
C4591001 1117 11171120
(USA/MISSOURI/60/M) Placebo Dose 2/67 11DEC2020 16DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 15DEC2020,
B.1.2
Chills
New loss of
taste or smell
C4591001 1117 11171121
(USA/MISSOURI/34/F) Placebo Dose 2/42 16NOV2020 11JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 22NOV2020,
B.1.2
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1117 11171141
(USA/MISSOURI/73/F) Placebo Dose 2/53 04DEC2020 25DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 06DEC2020,
INDETERMINATE
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651065
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
New or
increased
muscle pain
Diarrhea
C4591001 1117 11171173
(USA/MISSOURI/61/M) Placebo Dose 2/38 22NOV2020 09DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 30NOV2020,
B.1.2
Sore throat
C4591001 1118 11181014
(USA/NEW YORK/38/F) Placebo Dose 2/119 28DEC2020 13JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.243
Chills
New loss of
taste or smell
Sore throat
C4591001 1118 11181076
(USA/NEW YORK/33/F) Placebo Dose 2/110 27DEC2020 08JAN2021 Neg/Neg/Neg Fever Pos/, 28DEC2020,
B.1.2
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651066
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1118 11181088
(USA/NEW YORK/73/M) Placebo Dose 2/36 20OCT2020 10NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 29OCT2020,
INDETERMINATE
New or
increased
muscle pain
C4591001 1120 11201091
(USA/GEORGIA/67/F) Placebo Dose 2/135 15JAN2021 19JAN2021 Neg/Neg/Neg Fever Pos/, 20JAN2021,
B.1.243
New or
increased
muscle pain
C4591001 1120 11201101
(USA/GEORGIA/48/F) Placebo Dose 2/133 04JAN2021 07FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 06JAN2021, B.1.2
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651067
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
Diarrhea
Vomiting
C4591001 1120 11201115
(USA/GEORGIA/19/F) Placebo Dose 2/73 06NOV2020 12NOV2020 Neg/Neg/Neg Fever Pos/, 09NOV2020, B.1
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1120 11201154
(USA/GEORGIA/35/F) Placebo Dose 2/168 17FEB2021 Neg/Neg/Neg Fever Pos/, 19FEB2021, B.1.2
C4591001 1120 11201191
(USA/GEORGIA/23/M) Placebo Dose 2/86 26NOV2020 28NOV2020 Neg/Neg/Neg Fever Pos/, 27NOV2020,
B.1.1.222
New or
increased
cough
Chills
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651068
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1120 11201353
(USA/GEORGIA/59/F) Placebo Dose 2/98 18FEB2021 10MAR2021 Neg/Neg/Neg New or
increased
cough Pos/, 04MAR2021, B.1
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1120 11201374
(USA/GEORGIA/71/F) Placebo Dose 2/49 28DEC2020 04JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 30DEC2020,
B.1.2
C4591001 1121 11211069
(USA/ILLINOIS/45/M) Placebo Dose 2/71 01DEC2020 20DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 04DEC2020, QNS
C4591001 1121 11211070
(USA/ILLINOIS/43/F) Placebo Dose 2/56 16NOV2020 20DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 27NOV2020,
B.1.369
New or
increased
muscle pain
C4591001 1121 11211094
(USA/ILLINOIS/28/M) Placebo Dose 2/86 23DEC2020 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 23DEC2020,
B.1.139
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651069
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New loss of
taste or smell
C4591001 1121 11211105
(USA/ILLINOIS/52/M) Placebo Dose 2/39 05NOV2020 10DEC2020 Neg/Neg/Neg Fever Pos/, 06NOV2020,
B.1.2
New or
increased
cough
Sore throat
C4591001 1122 11221025
(USA/OHIO/40/M) Placebo Dose 2/32 01NOV2020 16NOV2020 Neg/Neg/Neg Fever Pos/, 03NOV2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1123 11231025
(USA/NEBRASKA/60/F) Placebo Dose 2/77 08NOV2020 13DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 11NOV2020,
B.1.234
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651070
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Sore throat
C4591001 1123 11231073
(USA/NEBRASKA/25/F) Placebo Dose 2/10 10SEP2020 25SEP2020 Neg/Neg/Neg New or
increased
cough Pos/Pos, 11SEP2020,
B.1.369
Chills
New or
increased
muscle pain
Sore throat
C4591001 1123 11231086
(USA/NEBRASKA/35/F) Placebo Dose 2/57 27OCT2020 18NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 28OCT2020,
B.1.2
New or
increased
muscle pain
C4591001 1123 11231102
(USA/NEBRASKA/52/F) Placebo Dose 2/88 28NOV2020 11DEC2020 Neg/Neg/Neg Diarrhea Pos/, 01DEC2020,
B.1.509
C4591001 1123 11231103
(USA/NEBRASKA/63/M) BNT162b2 (30
μg) Dose 2/105 15DEC2020 26DEC2020 Neg/Neg/Neg Fever Pos/, 23DEC2020,
B.1.2
New or
increased
cough
Diarrhea
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651071
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1123 11231117
(USA/NEBRASKA/55/F) Placebo Dose 2/64 10NOV2020 22NOV2020 Neg/Neg/Neg Chills Pos/, 11NOV2020,
B.1.234
New or
increased
muscle pain
C4591001 1123 11231123
(USA/NEBRASKA/47/F) Placebo Dose 2/84 01DEC2020 11DEC2020 Neg/Neg/Neg Fever Pos/, 07DEC2020,
B.1.2
New or
increased
cough
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
Diarrhea
Vomiting
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651072
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1123 11231132
(USA/NEBRASKA/32/F) Placebo Dose 2/99 15DEC2020 26DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 16DEC2020, QNS
Chills
New or
increased
muscle pain
C4591001 1123 11231156
(USA/NEBRASKA/33/F) Placebo Dose 2/55 07NOV2020 30NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 12NOV2020,
B.1.2
New or
increased
shortness of
breath
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1123 11231182
(USA/NEBRASKA/65/M) Placebo Dose 2/108 30DEC2020 08JAN2021 Neg/Neg/Neg New loss of
taste or smell Pos/, 30DEC2020,
B.1.324
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651073
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1123 11231214
(USA/NEBRASKA/60/F) Placebo Dose 2/34 26OCT2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 05NOV2020,
B.1.2
New or
increased
shortness of
breath
Chills
New loss of
taste or smell
Sore throat
C4591001 1123 11231232
(USA/NEBRASKA/39/F) BNT162b2 (30
μg) Dose 2/83 21DEC2020 08JAN2021 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 23DEC2020,
B.1.2
New loss of
taste or smell
C4591001 1123 11231234
(USA/NEBRASKA/29/M) Placebo Dose 2/32 02NOV2020 12NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 03NOV2020,
B.1.2
New or
increased
muscle pain
Sore throat
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651074
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1123 11231255
(USA/NEBRASKA/76/M) Placebo Dose 2/20 24OCT2020 01NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 02NOV2020,
B.1.349
C4591001 1123 11231256
(USA/NEBRASKA/72/F) Placebo Dose 2/20 24OCT2020 25NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 02NOV2020,
B.1.349
C4591001 1123 11231284
(USA/NEBRASKA/67/M) Placebo Dose 2/12 24OCT2020 24NOV2020 Neg/Neg/Neg Fever Pos/, 26OCT2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1123 11231339
(USA/NEBRASKA/35/F) Placebo Dose 2/38 02DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 09DEC2020,
B.1.369
New or
increased
cough
New or
increased
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651075
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1123 11231357
(USA/NEBRASKA/51/F) Placebo Dose 2/44 11DEC2020 18FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 15DEC2020, B.1
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1124 11241007
(USA/RHODE ISLAND/60/F) Placebo Dose 2/85 23NOV2020 03DEC2020 Neg/Neg/Neg Fever Pos/, 24NOV2020,
B.1.517
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651076
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1124 11241052
(USA/RHODE ISLAND/39/F) Placebo Dose 2/101 18DEC2020 31DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 21DEC2020, B.1
C4591001 1124 11241117
(USA/RHODE ISLAND/57/F) Placebo Dose 2/60 14NOV2020 19NOV2020 Neg/Neg/Neg New or
increased
shortness of
breath Pos/, 15NOV2020,
B.1.2
C4591001 1124 11241128
(USA/RHODE ISLAND/67/M) Placebo Dose 2/88 17DEC2020 Neg/Neg/Neg Fever Pos/, 18JAN2021,
B.1.361
New or
increased
cough
New or
increased
shortness of
breath
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651077
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1124 11241176
(USA/RHODE ISLAND/49/M) Placebo Dose 2/72 03DEC2020 20DEC2020 Neg/Neg/Neg Fever Pos/, 04DEC2020,
B.1.517
New or
increased
cough
Chills
New or
increased
muscle pain
C4591001 1125 11251006
(USA/NEBRASKA/35/M) Placebo Dose 2/42 11OCT2020 12OCT2020 Neg/Neg/Neg Fever Pos/, 11OCT2020,
B.1.139
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651078
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1125 11251014
(USA/NEBRASKA/45/F) Placebo Dose 2/59 30OCT2020 17NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020,
B.1.413
New or
increased
cough
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Diarrhea
C4591001 1125 11251023
(USA/NEBRASKA/49/M) Placebo Dose 2/56 27OCT2020 18NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 06NOV2020,
B.1.2
New or
increased
shortness of
breath
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651079
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1125 11251028
(USA/NEBRASKA/39/F) Placebo Dose 2/27 29SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos/, 01OCT2020, B.1
Chills
New or
increased
muscle pain
Sore throat
C4591001 1125 11251038
(USA/NEBRASKA/28/M) Placebo Dose 2/74 16NOV2020 Neg/Neg/Neg Diarrhea Pos/, 23NOV2020,
B.1.240
C4591001 1125 11251049
(USA/NEBRASKA/52/M) Placebo Dose 2/50 27OCT2020 24DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 02NOV2020,
B.1.2
Sore throat
C4591001 1125 11251088
(USA/NEBRASKA/67/M) Placebo Dose 2/92 14DEC2020 10JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 23DEC2020, B.1
New or
increased
shortness of
breath
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651080
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1125 11251098
(USA/NEBRASKA/33/F) Placebo Dose 2/78 02DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 03DEC2020,
B.1.2
C4591001 1125 11251106
(USA/NEBRASKA/44/F) Placebo Dose 2/68 20NOV2020 04DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 20NOV2020,
B.1.2
Sore throat
C4591001 1125 11251109
(USA/NEBRASKA/46/F) Placebo Dose 2/51 04NOV2020 18NOV2020 Neg/Neg/Neg Fever Pos/, 05NOV2020,
B.1.2
New or
increased
shortness of
breath
New or
increased
muscle pain
Diarrhea
C4591001 1125 11251114
(USA/NEBRASKA/59/M) Placebo Dose 2/38 22OCT2020 26OCT2020 Neg/Neg/Neg Fever Pos/Pos, 28OCT2020,
B.1.2
C4591001 1125 11251124
(USA/NEBRASKA/39/M) Placebo Dose 2/53 08NOV2020 10NOV2020 Neg/Neg/Neg Fever Pos/, 10NOV2020,
B.1.139
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651081
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
muscle pain
C4591001 1125 11251177
(USA/NEBRASKA/50/F) BNT162b2 (30
μg) Dose 2/68 29NOV2020 13DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 03DEC2020,
B.1.2
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Sore throat
Diarrhea
C4591001 1125 11251208
(USA/NEBRASKA/51/F) Placebo Dose 2/43 13NOV2020 18NOV2020 Neg/Neg/Neg New or
increased
cough Pos/Pos, 19NOV2020,
B.1.139
New loss of
taste or smell
C4591001 1125 11251215
(USA/NEBRASKA/43/M) Placebo Dose 2/25 06NOV2020 13NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 11NOV2020,
B.1.361
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651082
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1125 11251218
(USA/NEBRASKA/41/F) Placebo Dose 2/37 20NOV2020 04DEC2020 Neg/Neg/Neg Chills Pos/, 23NOV2020,
B.1.2
New loss of
taste or smell
C4591001 1126 11261017
(USA/CALIFORNIA/34/F) Placebo Dose 2/50 20OCT2020 20NOV2020 Neg/Neg/Neg Fever Pos/, 21OCT2020,
B.1.2
New or
increased
muscle pain
C4591001 1126 11261179
(USA/CALIFORNIA/60/M) Placebo Dose 2/85 30DEC2020 28JAN2021 Neg/Neg/Neg Fever Pos/, 04JAN2021,
B.1.311
New or
increased
cough
Chills
New or
increased
muscle pain
C4591001 1128 11281156
(USA/TEXAS/53/M) Placebo Dose 2/115 31DEC2020 15JAN2021 Neg/Neg/Neg Fever Pos/, 06JAN2021, B.1.2
New or
increased
cough
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651083
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Diarrhea
C4591001 1128 11281165
(USA/TEXAS/26/F) Placebo Dose 2/46 29OCT2020 03NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 02NOV2020,
B.1.2
Sore throat
C4591001 1128 11281194
(USA/TEXAS/82/M) Placebo Dose 2/112 05JAN2021 19JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 21JAN2021, A.2
Vomiting
C4591001 1128 11281224
(USA/TEXAS/46/M) Placebo Dose 2/88 14DEC2020 29DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 17DEC2020,
B.1.2
New or
increased
shortness of
breath
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651084
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Chills
New or
increased
muscle pain
Sore throat
C4591001 1128 11281281
(USA/TEXAS/36/F) Placebo Dose 2/51 12NOV2020 13NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020,
B.1.2
New or
increased
muscle pain
Sore throat
C4591001 1128 11281312
(USA/TEXAS/40/M) Placebo Dose 2/66 04DEC2020 15JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 08DEC2020,
B.1.2
New loss of
taste or smell
Sore throat
C4591001 1128 11281375
(USA/TEXAS/57/F) Placebo Dose 2/81 27DEC2020 29DEC2020 Neg/Neg/Neg New loss of
taste or smell Pos/, 28DEC2020,
B.1.2
C4591001 1129 11291044
(USA/FLORIDA/62/F) Placebo Dose 2/92 24NOV2020 09DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 24NOV2020, B.1
New loss of
taste or smell
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651085
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Diarrhea
C4591001 1131 11311036
(USA/OHIO/62/F) Placebo Dose 2/112 29DEC2020 13JAN2021 Neg/Neg/Neg Fever Pos/, 30DEC2020,
B.1.2
New or
increased
cough
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1131 11311039
(USA/OHIO/69/F) Placebo Dose 2/107 23DEC2020 26DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 28DEC2020,
B.1.2
Diarrhea
C4591001 1131 11311045
(USA/OHIO/40/M) Placebo Dose 2/143 31JAN2021 07FEB2021 Neg/Neg/Neg Fever Pos/, 01FEB2021, B.1.2
New or
increased
cough
Chills
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651086
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
Diarrhea
Vomiting
C4591001 1131 11311100
(USA/OHIO/64/M) Placebo Dose 2/58 12NOV2020 30NOV2020 Neg/Neg/Neg Fever Pos/, 13NOV2020,
B.1.2
Chills
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1131 11311113
(USA/OHIO/40/F) Placebo Dose 2/59 21NOV2020 23NOV2020 Neg/Neg/Neg New or
increased
cough Pos/, 23NOV2020,
B.1.2
New or
increased
shortness of
breath
C4591001 1131 11311138
(USA/OHIO/45/F) Placebo Dose 2/45 07NOV2020 01DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 10NOV2020, B.1
New or
increased
shortness of
breath
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651087
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
C4591001 1131 11311160
(USA/OHIO/27/F) Placebo Dose 2/52 18NOV2020 02DEC2020 Neg/Neg/Neg New or
increased
cough Pos/, 23NOV2020,
B.1.2
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
Sore throat
C4591001 1131 11311170
(USA/OHIO/60/F) BNT162b2 (30
μg) Dose 2/58 27NOV2020 22FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 29NOV2020,
B.1.2
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
C4591001 1131 11311241
(USA/OHIO/50/M) Placebo Dose 2/63 03JAN2021 10JAN2021 Neg/Neg/Neg New or
increased
cough Pos/, 11JAN2021,
B.1.361
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651088
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
New or
increased
shortness of
breath
Chills
New or
increased
muscle pain
C4591001 1131 11311269
(USA/OHIO/16/M) Placebo Dose 2/45 28JAN2021 04FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 28JAN2021,
B.1.429
New or
increased
shortness of
breath
Chills
C4591001 1133 11331097
(USA/FLORIDA/46/F) Placebo Dose 2/143 18JAN2021 08FEB2021 Neg/Neg/Neg Fever Pos/, 02FEB2021, QNS
New or
increased
cough
New or
increased
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651089
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/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),
Swab Date, SARS -
CoV -2 Lineage
shortness of
breath
Chills
New or
increased
muscle pain
New loss of
taste or smell
Sore throat
Diarrhea
C4591001 1133 11331209
(USA/FLORIDA/30/M) Placebo Dose 2/32 10OCT2020 15OCT2020 Neg/Neg/Neg New or
increased
cough Pos/, 13OCT2020, B.1
Sore throat
C4591001 1133 11331333
(USA/FLORIDA/46/F) Placebo Dose 2/108 08JAN2021 09FEB2021 Neg/Neg/Neg New or
increased
cough Pos/, 18JAN2021,
B.1.1.29
New or
increased
muscle pain
C4591001 1133 11331335
(USA/FLORIDA/51/M) Placebo Dose 2/108 08JAN2021 27JAN2021 Neg/Neg/Neg Fever Pos/, 18JAN2021,
B.1.1.29
090177e1972f8110\Final\Final On: 02-Jun-2021 12:50 (GMT)
FDA-CBER-2021-5683-0651090
16.2.8.6 Listing of Subjects and SARS -CoV -2 Variants 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 – Blinded Placebo -Controlled Follow -up Period
– Evaluable Efficacy (7 Days) Population
Subject
(Country/Region/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel Daya Start Date
of
First
Symptom Stop
…[truncated]