Document text
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
Vaccine Group
(as Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart
Date Stop
DateVisit 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.
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: 03NOV2021 (09:31) Source Data: adsympt Table Generation: 08NOV2021 (09:43)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File:
./nda2 unblinded/C4591001 SPeds/ads ympt l001 symsevd1aaiped
090177e1988b7715\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 1
FDA-CBER-2022-5812-0224637
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date
BNT162b2 (30
μg) C4591001 1007
10071409
(USA/13/M) Dose 1/10 31OCT2020 04NOV2020 Neg Neg/Neg/Neg Fever Pos/, 02NOV2020
C4591001 1007
10071622
(USA/15/M) Dose 1/2 31DEC2020 15FEB2021 Neg Neg/Neg/Neg New or
increased
muscle painPos/, 04JAN2021
New loss of
taste or smell
C4591001 1007
10071642
(USA/15/M) Dose 1/7 10JAN2021 20JAN2021 Neg Neg/Neg/Pos New or
increased coughPos/, 12JAN2021
Sore throa t
Placebo C4591001 1005
10051445
(USA/14/F)*# Dose 2/77 29MAR2021 02APR2021 Neg Neg/Neg/Neg New or
increased
muscle painPos/, 31MAR2021
New loss of
taste or smell
Sore throa t
C4591001 1006
10061206
(USA/12/M)*# Dose 2/10 01JAN2021 03JAN2021 Neg Neg/Neg/Neg Fever Pos/, 01JAN2021
C4591001 1006
10061214
(USA/14/M)*# Dose 2/114 15APR2021 19APR2021 Neg Neg/Neg/Neg New or
increased coughPos/, 22APR2021
C4591001 1006
10061219
(USA/14/M) Dose 2/129 01MAY2021 15JUL2021 Neg Neg/Neg/Neg New or
increased
shortness of
breathPos/, 04MAY2021
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 2
FDA-CBER-2022-5812-0224638
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 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
New loss of
taste or smell
Sore throa t
C4591001 1006
10061259
(USA/15/F) Dose 2/7 11JAN2021 24JAN2021 Neg Neg/Neg/Neg Fever Pos/, 18JAN2021
New or
increased cou gh
C4591001 1006
10061260
(USA/12/F)*# Dose 2/17 21JAN2021 27JAN2021 Neg Neg/Neg/Neg Sore throat Pos/, 21JAN2021
C4591001 1006
10061284
(USA/14/M)# Dose 2/8 15JAN2021 16JAN2021 Neg Neg/Neg/Pos Diarrhea Pos/, 18JAN2021
C4591001 1006
10061285
(USA/14/F)*# Dose 2/108 29APR2021 27MAY2021 Neg Neg/Neg/Neg Sore throat Pos/, 03MAY2021
C4591001 1007
10071505
(USA/12/F) Dose 2/2 29DEC2020 08JAN2021 Neg Neg/Neg/Pos New loss of
taste or smell Pos/, 03JAN2021
C4591001 1007
10071527
(USA/12/M)# Dose 2/10 07JAN2021 10JAN2021 Neg Neg/Neg/Pos Sore throat Pos/Pos,
10JAN2021
C4591001 1007
10071559
(USA/14/F)*# Dose 2/11 14JAN2021 26JAN2021 Neg Neg/Neg/Neg Fever Pos/, 15JAN2021
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 3
FDA-CBER-2022-5812-0224639
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 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 1007
10071603
(USA/13/M)*# Dose 2/35 22FEB2021 28FEB2021 Neg Neg/Neg/Neg Fever Pos/, 23FEB2021
New loss of
taste or smell
Sore throa t
C4591001 1007
10071613
(USA/13/M)*# Dose 2/54 13MAR2021 29MAR2021 Neg Neg/Neg/Neg Fever Pos/, 15MAR2021
New loss of
taste or smell
Diarrhea
C4591001 1007
10071660
(USA/12/M)*# Dose 2/74 10APR2021 17APR2021 Neg Neg/Neg/Neg Fever Pos/, 16APR2021
New or
increased cou gh
Sore throa t
C4591001 1008
10081871
(USA/14/F) Dose 1/14 12JAN2021 19JAN2021 Neg Neg/Neg/Neg New or
increased coughPos/, 18JAN2021
Sore throa t
C4591001 1008
10081884
(USA/15/F) Dose 1/19 18JAN2021 26JAN2021 Neg Neg/Neg/Pos Sore throat Pos/, 20JAN2021
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 4
FDA-CBER-2022-5812-0224640
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date
C4591001 1008
10081919
(USA/14/F)*# Dose 2/88 26APR2021 05MAY2021 Neg Neg/Neg/Neg New or
increased coughPos/, 28APR2021
Sore throa t
C4591001 1009
10091208
(USA/15/M)*# Dose 2/66 10JAN2021 14JAN2021 Neg Neg/Neg/Neg New or
increased coughPos/, 10JAN2021
New or
increased
shortness of
breath
New or
increased
muscle pain
Sore throa t
C4591001 1009
10091282
(USA/14/M)*# 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) Dose 1/19 01JAN2021 24FEB2021 Neg Neg/Neg/Pos Fever Pos/, 02JAN2021
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 5
FDA-CBER-2022-5812-0224641
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 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 cou gh
New or
increased
muscle pain
Sore throa t
C4591001 1009
10091365
(USA/12/M)*# Dose 2/79 07APR2021 15MAY2021 Neg Neg/Neg/Neg New loss of
taste or smell Pos/, 13APR2021
C4591001 1009
10091366
(USA/14/F) Dose 1/9 25DEC2020 01JAN2021 Neg Neg/Neg/Pos Fever Pos/, 28DEC2020
Chills
New or
increased
muscle pain
Sore throa t
C4591001 1009
10091412
(USA/15/M)*# Dose 2/29 01MAR2021 03MAR2021 Neg Neg/Neg/Neg New or
increased coughPos/, 01MAR2021
Sore throa t
C4591001 1013
10131844
(USA/13/M)*# Dose 2/144 14MAY2021 16MAY2021 Neg Neg/Neg/Neg Fever Pos/, 19MAY2021
C4591001 1016
10161316
(USA/15/M) Dose 1/17 01NOV2020 11NOV2020 Neg Neg/Neg/Pos New or
increased coughPos/, 02NOV2020
Chills
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 6
FDA-CBER-2022-5812-0224642
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 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
New loss of
taste or smell
Sore throa t
Diarrhea
C4591001 1016
10161319
(USA/12/F) Dose 2/6 09NOV2020 20NOV2020 Neg Neg/Neg/Neg Fever Pos/, 10NOV2020
New or
increased cou gh
Chills
New loss of
taste or smell
Sore throa t
C4591001 1016
10161379
(USA/13/M) Dose 1/13 19JAN2021 02FEB2021 Neg Neg/Neg/Neg New or
increased
muscle painPos/ (R1 Pos),
19JAN2021
(29JAN2021)
New loss of
taste or smell
Sore throa t
C4591001 1039
10391268
(USA/13/F)*# Dose 2/33 29JAN2021 03MAR2021 Neg Neg/Neg/Neg Fever Pos/, 29JAN2021
New or
increased cou gh
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 7
FDA-CBER-2022-5812-0224643
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 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
shortness of
breath
Chills
New or
increased
muscle pain
C4591001 1044
10441264
(USA/14/F) Dose 2/6 02JAN2021 05JAN2021 Neg Neg/Neg/Neg New or
increased coughPos/, 04JAN2021
Sore throa t
C4591001 1044
10441374
(USA/15/M)*# 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) Dose 1/5 28DEC2020 02JAN2021 Neg Neg/Neg/Pos Fever Pos/, 29DEC2020
Chills
Sore throa t
C4591001 1091
10911404
(USA/13/F)*# Dose 2/27 23JAN2021 Neg Neg/Neg/Neg New or
increased
shortness of
breathPos/, 25JAN2021
Chills
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 8
FDA-CBER-2022-5812-0224644
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 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
New loss of
taste or smell
Sore throa t
Diarrhea
C4591001 1091
10911407
(USA/12/M) Dose 2/6 02JAN2021 16JAN2021 Neg Neg/Neg/Neg New or
increased coughPos/, 06JAN2021
New or
increased
muscle pain
Diarrhea
C4591001 1123
11231468
(USA/15/F)*# Dose 2/76 27MAR2021 27MAR2021 Neg Neg/Neg/Neg New loss of
taste or smell Pos/, 30MAR2021
C4591001 1123
11231501
(USA/12/F) Dose 1/18 14JAN2021 02FEB2021 Neg Neg/Neg/Neg Fever Pos/, 19JAN2021
New or
increased cou gh
New or
increased
muscle pain
New loss of
taste or smell
Sore throa t
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 9
FDA-CBER-2022-5812-0224645
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date
C4591001 1124
11241248
(USA/13/F)*# Dose 2/96 11APR2021 14APR2021 Neg Neg/Neg/Neg Fever Pos/, 11APR2021
Sore throa t
C4591001 1126
11261287
(USA/15/M) Dose 1/15 30DEC2020 11JAN2021 Neg Neg/Neg/Pos Fever Pos/, 04JAN2021
C4591001 1139
11391219
(USA/13/F)*# Dose 2/72 31MAR2021 14APR2021 Neg Neg/Neg/Neg Fever Pos/, 01APR2021
New loss of
taste or smell
Sore throa t
C4591001 1142
11421388
(USA/15/M)*# Dose 2/25 19FEB2021 12MAR2021 Neg Neg/Neg/Neg Sore throat Pos/, 19FEB2021
C4591001 1147
11471280
(USA/12/M) Dose 1/6 09JAN2021 12JAN2021 Neg Neg/Neg/Un k Fever Pos/, 10JAN2021
Chills
C4591001 1150
11501204
(USA/14/M)*# Dose 2/32 04FEB2021 10FEB2021 Neg Neg/Neg/Neg New or
increased coughPos/, 05FEB2021
Sore throa t
C4591001 1150
11501291
(USA/15/M) Dose 1/2 12JAN2021 26JAN2021 Neg Neg/Neg/Neg New or
increased coughPos/, 13JAN2021
Sore throa t
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 10
FDA-CBER-2022-5812-0224646
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date
C4591001 1152
11521666
(USA/15/F)*# Dose 2/17 15JAN2021 23JAN2021 Neg Neg/Neg/Neg New or
increased coughPos/, 21JAN2021
New or
increased
muscle pain
New loss of
taste or smell
C4591001 1156
11561260
(USA/15/F)*# Dose 2/82 01FEB2021 05FEB2021 Neg Neg/Neg/Neg New or
increased
muscle painPos/, 01FEB2021
C4591001 1156
11561263
(USA/15/M)*# Dose 2/41 20DEC2020 25DEC2020 Neg Neg/Neg/Neg New or
increased coughPos/, 22DEC2020
C4591001 1156
11561305
(USA/13/M)*# Dose 2/141 11MAY2021 25MAY2021 Neg Neg/Neg/Neg New loss of
taste or smell Pos/, 14MAY2021
C4591001 1235
12351243
(USA/15/M)*# Dose 2/42 09FEB2021 11FEB2021 Neg Neg/Neg/Neg New or
increased coughPos/, 11FEB2021
Sore throa t
Diarrhea
C4591001 1270
12701237
(USA/13/F) 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 respirator y syndrome coronavirus 2; Unk = unknown.
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 11
FDA-CBER-2022-5812-0224647
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
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Baseline
SerostatusVisit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date
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. # indicates subject in the evaluable efficacy (7 days) population with f irst COVID-19 occurrence from 7 days after
Dose 2 and with or without evidence of infection prior to 7 day s after Dose 2.
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: 03NOV2021 (09:31) Source Data: adsympt Table Generation: 08NOV2021 (09:46)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File:
./nda2 _unblinded/C4591001 _S_Peds/ads ympt_l001_sympt_d1_ped_aai
090177e1988b77a3\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 12
FDA-CBER-2022-5812-0224648
16.2.8.4.1 Listing of Subjects With M ultiple COVID-19 Occurrenc e After Dose 1
– Subjects 12 Through 15 Years of Age – Dose 1 All-Available Ef ficacy Population
Vaccine Group
(as
Randomized) Subject
(Country/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS-CoV-2
NAAT Result
(Central Lab/Local
Labb),
Swab Date
Placebo C4591001 1270 12701237
(USA/13/F) Dose 1/13 19JAN2021 20JAN2021 Neg/Pos/Pos New or increased
shortness of breathPos/, 21JAN2021
Dose 1/20 26JAN2021 26JAN2021 Neg/Pos/Pos Diarrhea Pos/, 29JAN2021
Abbreviations: NAAT = nucleic acid amplification test; N-bindin g = SARS-CoV-2 nucleoprotein–binding; Neg = negative;
Pos = positive; SARS-CoV-2 = seve re acute respiratory syndrome coronavirus 2.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
b. SARS-CoV-2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS-CoV-2 test, Roche cobas® SARS-CoV-2 real-time
RT-PCR test (EUA200009/A001), or A bbott RealTime SARS-CoV-2 ass ay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 03NOV2021 (09:31) Source Data: adsympt Table Generation: 08NOV2021 (11:16)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 _unblinded/C4591001 _S_Peds/ads ympt_multi _cov_d1_aai_ped
090177e1988b77a4\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 13
FDA-CBER-2022-5812-0224649
16.2.8.6 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Fir st 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 Foll ow-up Period – Evaluable Efficac y (7 Days) Population
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date,
SARS-CoV-2
Lineage
Placebo C4591001 1005 10051445
(USA/NEW YORK/14/F) Dose 2/77 29MAR2021 02APR2021 Neg/Neg/Neg New or
increased muscle
painPos/,
31MAR2021,
B.1.1.7
New loss of taste
or smell
Sore throa t
C4591001 1006 10061206
(USA/UTAH/12/M)Dose 2/10 01JAN2021 03JAN2021 Neg/Neg/Neg Fever Pos/, 01JAN2021,
B.1.400
C4591001 1006 10061214
(USA/UTAH/14/M)Dose 2/114 15APR2021 19APR2021 Neg/Neg/Neg New or
increased cou ghPos/, 22APR2021,
B.1.1.7
C4591001 1006 10061260
(USA/UTAH/12/F) Dose 2/17 21JAN2021 27JAN2021 Neg/Neg/Neg Sore throat Pos/, 21JAN2021,
B.1.1.29
C4591001 1006 10061284
(USA/UTAH/14/M)Dose 2/8 15JAN2021 16JAN2021 Neg/Neg/Pos Diarrhea Pos/, 18JAN2021,
B.1.142
C4591001 1006 10061285
(USA/UTAH/14/F) Dose 2/108 29APR2021 27MAY2021 Neg/Neg/Neg Sore throat Pos/,
03MAY2021,
B.1.1.519
C4591001 1007 10071527
(USA/OHIO/12/M) Dose 2/10 07JAN2021 10JAN2021 Neg/Neg/Pos Sore throat Pos/Pos,
10JAN2021, B.1.2
C4591001 1007 10071559
(USA/OHIO/14/F) Dose 2/11 14JAN2021 26JAN2021 Neg/Neg/Neg Fever Pos/, 15JAN2021,
B.1.2
Sore throa t
C4591001 1007 10071603
(USA/OHIO/13/M) Dose 2/35 22FEB2021 28FEB2021 Neg/Neg/Neg Fever Pos/, 23FEB2021,
B.1.2
090177e1988b77a6\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 14
FDA-CBER-2022-5812-0224650
16.2.8.6 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Fir st 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 Foll ow-up Period – Evaluable Efficac y (7 Days) Population
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date,
SARS-CoV-2
Lineage
New loss of taste
or smell
Sore throa t
C4591001 1007 10071613
(USA/OHIO/13/M) Dose 2/54 13MAR2021 29MAR2021 Neg/Neg/Neg Fever Pos/,
15MAR2021,
B.1.1.222
New loss of taste
or smell
Diarrhea
C4591001 1007 10071660
(USA/OHIO/12/M) Dose 2/74 10APR2021 17APR2021 Neg/Neg/Neg Fever Pos/, 16APR2021,
QNS
New or
increased cou gh
Sore throa t
C4591001 1008 10081919
(USA/MISSOURI/14/F)Dose 2/88 26APR2021 05MAY2021 Neg/Neg/Neg New or
increased cou ghPos/, 28APR2021,
B.1.1.7
Sore throa t
C4591001 1009 10091208
(USA/UTAH/15/M)Dose 2/66 10JAN2021 14JAN2021 Neg/Neg/Neg New or
increased cou ghPos/, 10JAN2021,
B.1.2
New or
increased
shortness of
breath
090177e1988b77a6\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 15
FDA-CBER-2022-5812-0224651
16.2.8.6 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Fir st 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 Foll ow-up Period – Evaluable Efficac y (7 Days) Population
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date,
SARS-CoV-2
Lineage
New or
increased muscle
pain
Sore throa t
C4591001 1009 10091282
(USA/UTAH/14/M)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 throa t
C4591001 1009 10091365
(USA/UTAH/12/M)Dose 2/79 07APR2021 15MAY2021 Neg/Neg/Neg New loss of taste
or smellPos/, 13APR2021,
B.1.1.7
C4591001 1009 10091412
(USA/UTAH/15/M) Dose 2/29 01MAR2021 03MAR2021 Neg/Neg/Neg New or
increased coughPos/,
01MAR2021,
B.1.2
Sore throa t
C4591001 1013 10131844
(USA/FLORIDA/13/M) Dose 2/144 14MAY2021 16MAY2021 Neg/Neg/Neg Fever Pos/,
19MAY2021,
B.1.1.7
C4591001 1039 10391268
(USA/TEXAS/13/F)Dose 2/33 29JAN2021 03MAR2021 Neg/Neg/Neg Fever Pos/, 29JAN2021,
B.1
New or
increased cou gh
090177e1988b77a6\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 16
FDA-CBER-2022-5812-0224652
16.2.8.6 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Fir st 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 Foll ow-up Period – Evaluable Efficac y (7 Days) Population
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns 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 1044 10441374
(USA/VIRGINIA/15/M)Dose 2/13 14FEB2021 17FEB2021 Neg/Neg/Neg Chills Pos/, 16FEB2021,
B.1.243
New loss of taste
or smell
Vomitin g
C4591001 1091 10911404
(USA/OHIO/13/F) Dose 2/27 23JAN2021 Neg/Neg/Neg New or
increased
shortness of
breathPos/, 25JAN2021,
B.1.361
Chills
New or
increased muscle
pain
New loss of taste
or smell
Sore throa t
Diarrhea
090177e1988b77a6\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 17
FDA-CBER-2022-5812-0224653
16.2.8.6 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Fir st 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 Foll ow-up Period – Evaluable Efficac y (7 Days) Population
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date,
SARS-CoV-2
Lineage
C4591001 1123 11231468
(USA/NEBRASKA/15/F) Dose 2/76 27MAR2021 27MAR2021 Neg/Neg/Neg New loss of taste
or smell Pos/,
30MAR2021,
B.1.2
C4591001 1124 11241248
(USA/RHODE ISLAND/13/F)Dose 2/96 11APR2021 14APR2021 Neg/Neg/Neg Fever Pos/, 11APR2021,
B.1.526
Sore throa t
C4591001 1139 11391219
(USA/NORTH CAROLINA/13/F)Dose 2/72 31MAR2021 14APR2021 Neg/Neg/Neg Fever Pos/, 01APR2021,
B.1.1.7
New loss of taste
or smell
Sore throa t
C4591001 1142 11421388
(USA/TEXAS/15/M)Dose 2/25 19FEB2021 12MAR2021 Neg/Neg/Neg Sore throat Pos/, 19FEB2021,
B.1.2
C4591001 1150 11501204
(USA/OHIO/14/M) Dose 2/32 04FEB2021 10FEB2021 Neg/Neg/Neg New or
increased cou ghPos/, 05FEB2021,
B.1.2
Sore throa t
C4591001 1152 11521666
(USA/CALIFORNIA/15/F)Dose 2/17 15JAN2021 23JAN2021 Neg/Neg/Neg New or
increased cou ghPos/, 21JAN2021,
B.1.427
New or
increased muscle
pain
New loss of taste
or smell
090177e1988b77a6\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 18
FDA-CBER-2022-5812-0224654
16.2.8.6 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Fir st 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 Foll ow-up Period – Evaluable Efficac y (7 Days) Population
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date of
First
Symptom Stop Date of
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date,
SARS-CoV-2
Lineage
C4591001 1156 11561260
(USA/FLORIDA/15/F) Dose 2/82 01FEB2021 05FEB2021 Neg/Neg/Neg New or
increased muscle
painPos/, 01FEB2021,
B.1.2
C4591001 1156 11561263
(USA/FLORIDA/15/M)Dose 2/41 20DEC2020 25DEC2020 Neg/Neg/Neg New or
increased cou ghPos/, 22DEC2020,
B.1.369
C4591001 1156 11561305
(USA/FLORIDA/13/M) Dose 2/141 11MAY2021 25MAY2021 Neg/Neg/Neg New loss of taste
or smell Pos/,
14MAY2021,
B.1.1.7
C4591001 1235 12351243
(USA/LOUISIANA/15/M)Dose 2/42 09FEB2021 11FEB2021 Neg/Neg/Neg New or
increased cou ghPos/, 11FEB2021,
B.1.2
Sore throa t
Diarrhea
Abbreviations: NAAT = nucleic acid amplification test; N-bindin g = SARS-CoV-2 nucleoprotein–binding; Neg = negative; Pos = pos itive;
QNS = not quantifiable samples; S ARS-CoV-2 = severe acute respi ratory syndrome coronavirus 2.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
b. SARS-CoV-2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS-CoV-2 test, Roche cobas® SARS-CoV-2 real-time RT-
PCR test (EUA200009/A001), or Abbott RealTime SARS-CoV-2 assay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 02NOV2021 (15:56) Source Data: adsympt Table Generation: 04NOV2021 (14:59)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File:
./nda2 _unblinded/C4591001 _S_Peds/adxb _l001_seq_d2_cov_peds_eval
090177e1988b77a6\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 19
FDA-CBER-2022-5812-0224655
16.2.8.7 Listing of Subjects 12 Throu gh 15 Years of Age and SARS-CoV-2 Variants With Multiple COVID-19
Occurrence After Dose 1 – Dose 1 All-Available Efficacy Populat ion
Vaccine Group
(as
Randomized) Subject
(Country/Region/Age in
Years/Sex) Dose/Rel DayaStart Date
of
First
Symptom Stop Date o f
Last
Symptom Visit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAATSigns and
Symptoms SARS-CoV-2
NAAT Result
(Central
Lab/Local Labb),
Swab Date,
SARS-CoV-2
Lineage
Placebo C4591001 1270 12701237
(USA/CALIFORNIA/13/F) Dose 1/13 19JAN2021 20JAN2021 Neg/Pos/Pos New or increased
shortness of
breathPos/, 21JAN2021,
B.1.1.38
Dose 1/20 26JAN2021 26JAN2021 Neg/Pos/Pos Diarrhea Pos/, 29JAN2021,
B.1.1.1
Abbreviations: NAAT = nucleic acid amplification test; N-bindin g = SARS-CoV-2 nucleoprotein–binding; Neg = negative; Pos = pos itive;
SARS-CoV-2 = severe acute respir atory syndrome coronavirus 2.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
b. SARS-CoV-2 NAAT results from the local lab are based on the Cepheid Xpert® Xpress SARS-CoV-2 test, Roche cobas® SARS-CoV-2 real-time RT-
PCR test (EUA200009/A001), or Abbott RealTime SARS-CoV-2 assay (EUA200023/A001) only.
PFIZER CONFIDENTIAL SDTM Creation: 02NOV2021 (15:56) Source Data: adsympt Table Generation: 04NOV2021 (14:59)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File:
./nda2 unblinded/C4591001 SPeds/adxb l001 seqd1mulcov ped aai
090177e1988b77a5\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 20
FDA-CBER-2022-5812-0224656