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16.2.8.1.1 Listing of Subjects With F irst Severe COVID-19 Occur rence After Dose 1
– Subjects 12 Through 15 Years of Age – Blinded Placebo-Control led Follow-up Period
– Dose 1 All-Available Efficacy Population – CDC+Protocol
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as Randomized) Dose/Rel DayaStart
Date Stop
Date Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs,
Symptoms,
and Events SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date Protocol/CDC
Defined
Symptoms
No subject meets the
reportin g criteria.
Abbreviations: NAAT = nucleic acid amplification test; N-bindin g = SARS-CoV-2 nucleoprotein–binding;
SARS-CoV-2 = severe acute respir atory syndrome coronavirus 2.
Note: HIV-positive subjects are included in this listing but not included in the analyses of the overall study objectives.
a. Relative day (Rel Day) = da te of first symptom - date of last dose before fi rst symptom + 1.
b. SARS-CoV-2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS-CoV-2 test, Roche cobas® SARS-CoV-2 real-time RT-
PCR test (EUA200009/A001), or Abbott RealTime SARS-CoV-2 assay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 27MAR2021 (01:55) Source Data: adsympt Table Generation: 02APR2021 (10:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/ads ympt l001 symsevd1aaiped
090177e196b266fb\Final\Final On: 03-Apr-2021 02:29 (GMT)
Page 1
FDA-CBER-2022-5812-0224078
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1006
10061206
(USA/12/M)* Placebo Dose 2/10 01JAN2021 03JAN2021 Neg Neg/Neg/Neg Fever Pos/, 01JAN2021
C4591001 1006
10061259
(USA/15/F) Placebo Dose 2/7 11JAN2021 24JAN2021 Neg Neg/Neg/Neg Fever Pos/, 18JAN2021
New or increased
cough
C4591001 1006
10061260
(USA/12/F)* Placebo Dose 2/17 21JAN2021 27JAN2021 Neg Neg/Neg/Neg Sore throat Pos/, 21JAN2021
C4591001 1006
10061284
(USA/14/M) Placebo Dose 2/8 15JAN2021 16JAN2021 Neg Neg/Neg/Pos Diarrhea Pos/, 18JAN2021
C4591001 1007
10071409
(USA/13/M) BNT162b2 (30
μg) Dose 1/10 31OCT2020 04NOV2020 Neg Neg/Neg/Neg Fever Pos/, 02NOV2020
C4591001 1007
10071505
(USA/12/F) Placebo Dose 2/2 29DEC2020 08JAN2021 Neg Neg/Neg/Pos New loss of taste
or smell Pos/, 03JAN2021
C4591001 1007
10071527
(USA/12/M) Placebo Dose 2/10 07JAN2021 10JAN2021 Neg Neg/Neg/Pos Sore throat Pos/Pos,
10JAN2021
C4591001 1007
10071559
(USA/14/F)* Placebo Dose 2/11 14JAN2021 26JAN2021 Neg Neg/Neg/Neg Fever Pos/, 15JAN2021
Sore throa t
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
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FDA-CBER-2022-5812-0224079
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1007
10071603
(USA/13/M)* Placebo Dose 2/35 22FEB2021 28FEB2021 Neg Neg/Neg/Neg Fever Pos/, 23FEB2021
New loss of taste
or smell
Sore throa t
C4591001 1007
10071622
(USA/15/M) BNT162b2 (30
μg) Dose 1/2 31DEC2020 15FEB2021 Neg Neg/Neg/Neg New or increased
muscle pain Pos/, 04JAN2021
New loss of taste
or smell
C4591001 1007
10071642
(USA/15/M) BNT162b2 (30
μg) Dose 1/7 10JAN2021 20JAN2021 Neg Neg/Neg/Pos New or increased
cough Pos/, 12JAN2021
Sore throa t
C4591001 1008
10081871
(USA/14/F) Placebo Dose 1/14 12JAN2021 19JAN2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 18JAN2021
Sore throa t
C4591001 1008
10081884
(USA/15/F) Placebo Dose 1/19 18JAN2021 26JAN2021 Neg Neg/Neg/Pos Sore throat Pos/, 20JAN2021
C4591001 1009
10091208
(USA/15/M)* Placebo Dose 2/66 10JAN2021 14JAN2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 10JAN2021
New or increased
shortness of
breath
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 3
FDA-CBER-2022-5812-0224080
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
New or increased
muscle pain
Sore throa t
C4591001 1009
10091282
(USA/14/M)* Placebo Dose 2/42 01FEB2021 02FEB2021 Neg Neg/Neg/Neg Chills Pos/, 02FEB2021
New or increased
muscle pain
New loss of taste
or smell
Sore throa t
C4591001 1009
10091338
(USA/15/F) Placebo Dose 1/19 01JAN2021 24FEB2021 Neg Neg/Neg/Pos Fever Pos/, 02JAN2021
New or increased
cough
New or increased
muscle pain
Sore throa t
C4591001 1009
10091366
(USA/14/F) Placebo Dose 1/9 25DEC2020 01JAN2021 Neg Neg/Neg/Pos Fever Pos/, 28DEC2020
Chills
New or increased
muscle pain
Sore throa t
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 4
FDA-CBER-2022-5812-0224081
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1009
10091412
(USA/15/M)* Placebo Dose 2/29 01MAR2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 01MAR2021
Sore throa t
C4591001 1016
10161316
(USA/15/M) Placebo Dose 1/17 01NOV2020 11NOV2020 Neg Neg/Neg/Pos New or increased
cough Pos/, 02NOV2020
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throa t
Diarrhea
C4591001 1016
10161319
(USA/12/F) Placebo Dose 2/6 09NOV2020 20NOV2020 Neg Neg/Neg/Neg Fever Pos/, 10NOV2020
New or increased
cough
Chills
New loss of taste
or smell
Sore throa t
C4591001 1016
10161379
(USA/13/M) Placebo Dose 1/13 19JAN2021 02FEB2021 Neg Neg/Neg/Neg New or increased
muscle pain Pos/ (R1 Pos),
19JAN2021
(29JAN2021)
New loss of taste
or smell
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 5
FDA-CBER-2022-5812-0224082
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
Sore throa t
C4591001 1039
10391268
(USA/13/F)* Placebo Dose 2/33 29JAN2021 03MAR2021 Neg Neg/Neg/Neg Fever Pos/, 29JAN2021
New or increased
cough
New or increased
shortness of
breath
Chills
New or increased
muscle pain
C4591001 1044
10441264
(USA/14/F) Placebo Dose 2/6 02JAN2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 04JAN2021
Sore throa t
C4591001 1044
10441374
(USA/15/M)* Placebo Dose 2/13 14FEB2021 17FEB2021 Neg Neg/Neg/Neg Chills Pos/, 16FEB2021
New loss of taste
or smell
Vomitin g
C4591001 1057
10571428
(USA/14/M) Placebo Dose 1/5 28DEC2020 02JAN2021 Neg Neg/Neg/Pos Fever Pos/, 29DEC2020
Chills
Sore throa t
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 6
FDA-CBER-2022-5812-0224083
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1091
10911404
(USA/13/F)* Placebo Dose 2/27 23JAN2021 Neg Neg/Neg/Neg New or increased
shortness of
breathPos/, 25JAN2021
Chills
New or increased
muscle pain
New loss of taste
or smell
Sore throa t
Diarrhea
C4591001 1091
10911407
(USA/12/M) Placebo Dose 2/6 02JAN2021 16JAN2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 06JAN2021
New or increased
muscle pain
Diarrhea
C4591001 1123
11231501
(USA/12/F) Placebo Dose 1/18 14JAN2021 02FEB2021 Neg Neg/Neg/Neg Fever Pos/, 19JAN2021
New or increased
cough
New or increased
muscle pain
New loss of taste
or smell
Sore throa t
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 7
FDA-CBER-2022-5812-0224084
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1126
11261287
(USA/15/M) Placebo Dose 1/15 30DEC2020 11JAN2021 Neg Neg/Neg/Pos Fever Pos/, 04JAN2021
C4591001 1142
11421388
(USA/15/M)* Placebo Dose 2/25 19FEB2021 Neg Neg/Neg/Neg Sore throat Pos/, 19FEB2021
C4591001 1147
11471280
(USA/12/M) Placebo Dose 1/6 09JAN2021 12JAN2021 Neg Neg/Neg/Un k Fever Pos/, 10JAN2021
Chills
C4591001 1150
11501204
(USA/14/M)* Placebo Dose 2/32 04FEB2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 05FEB2021
Sore throa t
C4591001 1150
11501291
(USA/15/M) Placebo Dose 1/2 12JAN2021 26JAN2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 13JAN2021
Sore throa t
C4591001 1152
11521666
(USA/15/F)* Placebo Dose 2/17 15JAN2021 23JAN2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 21JAN2021
New or increased
muscle pain
New loss of taste
or smell
C4591001 1156
11561260
(USA/15/F)* Placebo Dose 2/82 01FEB2021 05FEB2021 Neg Neg/Neg/Neg New or increased
muscle pain Pos/, 01FEB2021
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 8
FDA-CBER-2022-5812-0224085
16.2.8.1.2 Listing of Subjects With First COVID-19 Occurrence A fter Dose 1 – Subjects 12 Through 15 Years of Age
– Blinded Placebo-Controlled F ollow-up Period – Dose 1 All-Avai lable Efficacy Population
Subject
(Country/Age in
Years/Sex) Vaccine Group
(as
Randomized) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
Serostatus Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
C4591001 1156
11561263
(USA/15/M)* Placebo Dose 2/41 20DEC2020 25DEC2020 Neg Neg/Neg/Neg New or increased
cough Pos/, 22DEC2020
C4591001 1235
12351243
(USA/15/M)* Placebo Dose 2/42 09FEB2021 11FEB2021 Neg Neg/Neg/Neg New or increased
cough Pos/, 11FEB2021
Sore throa t
Diarrhea
C4591001 1270
12701237
(USA/13/F) Placebo Dose 1/13 19JAN2021 20JAN2021 Pos Neg/Pos/Pos New or increased
shortness of
breathPos/, 21JAN2021
Abbreviations: NAAT = nucleic acid amplification test; N-bindin g = SARS-CoV-2 nucleoprotein–binding; Neg = negative;
Pos = positive; R1 = repeat centr al swab 1; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Unk = unknown.
Note: * indicates subject in the evaluable efficacy (7 days) pop ulation with first COVID-19 occurrence from 7 days after Dose 2 and without evidence of
infection prior to 7 days after Dose 2.
Note: HIV-positive subjects are included in this listing but not included in the analyses of the overall study objectives.
a. Relative day (Rel Day) = da te of first symptom - date of last dose before fi rst symptom + 1.
b. SARS-CoV-2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS-CoV-2 test, Roche cobas® SARS-CoV-2 real-time RT-
PCR test (EUA200009/A001), or Abbott RealTime SARS-CoV-2 assay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 27MAR2021 (01:55) Source Data: adsympt Table Generation: 04APR2021 (00:39)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/ads ympt_l001_sympt_d1_ped_aai
090177e196b560e9\Final\Final On: 06-Apr-2021 02:08 (GMT)
Page 9
FDA-CBER-2022-5812-0224086