Document text
E-Diary Transmission – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population .................................................... 2
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Pop ulation .................................................................................................................................................................................................................................. 4
Duration (Days) From First to Last Day of Local Reactions – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety
Population ........................................................................................................................................................................................................................................... 10
Onset Days for Local Reactions – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population ................................... 12
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population ................................................................................................................................................................................................................................ 15
Duration (Days) From First to Last Day of Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety
Population ........................................................................................................................................................................................................................................... 27
Onset Days for Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population .................................. 33
Listing of Severe and Grade 4 Local Reactions – Subjects 12 Through 25 Years of Age (Reactogenicity Subset) .......................................................................... 38
Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset) .......................................................................... 42
Subjects Reporting Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age
(Reactogenicity Subset) – Safety Population ...................................................................................................................................................................................... 73
Subjects Reporting Systemic Events, by Maximum Severity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age
(Reactogenicity Subset) – Safety Population ...................................................................................................................................................................................... 76
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492645
E-Diary Transmission – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
na (%) na (%) na (%) na (%)
Vaccinated at Dose 1b 1131 537 1129 561
E-diary
Not transmittedc 4 (0.4) 3 (0.6 (1.1) 2 (0.2) 8 (1.4)
Transmittedd
Day 1 1081 (95.6) 506509 (94.28) 1066 (94.4) 514 (91.6)
Day 2 1089 1090 (96.34) 509 (94.8 512 (95.3 ) 1073 (95.0) 519 (92.5)
Day 3 1048 1049 (92.7) 485488 (90.39) 1056 (93.5) 515 (91.8)
Day 4 1025 (90.6) 478480 (89.04) 1011 (89.5) 503504 (89.78)
Day 5 1012 (89.5) 472 (87.9 473 (88.1 ) 1002 1003 (88.8) 492 (87.7)
Day 6 991 (87.6) 474476 (88.36) 1002 (88.8) 484 (86.3)
Day 7 1006 (88.9) 476 (88.6 478 (89.0 ) 989990 (87.67) 476 (84.8)
All 7 dayse 718719 (63.56) 347 (64.6 349 (65.0 ) 695697 (61.67) 343344 (61.13)
Vaccinated at Dose 2b 1124 525 1117 535
E-diary
Not transmittedc 2723 (2.40) 35 (6.731 (5.9) 3938 (3.54) 3938 (7.31)
Transmittedd
Day 1 852 (75.8 858 (76.3 ) 377 (71.8 381 (72.6 ) 785786 (70.34) 348350 (65.04)
Day 2 984 (87.5 991 (88.2 ) 437 (83.2 446 (85.0 ) 879881 (78.79) 406 (75.9 408 (76.3 )
Day 3 959963 (85.37) 419 (79424 (80.8) 904 (80.9 905 (81.0 ) 428 (80.0)
Day 4 913914 (81.23) 418 (79.6 420 (80.0 ) 907 (81.2) 431 (80.6)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492646
E-Diary Transmission – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
na (%) na (%) na (%) na (%)
Day 5 917 (81.6) 421423 (80.26) 909 (81.4) 433 (80.9)
Day 6 930931 (82.78) 414 (78.9) 923 (82.6) 425 (79.4)
Day 7 925 (82.3) 412 (78.5) 912 (81.6) 426427 (79.68)
All 7 dayse 463465 (41.24) 217220 (41.39) 414415 (37.12) 201 (37.6)
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary but not included in the analyses of the overall study objectives.
a. n = Number of subjects with the specified characteristic.
b. These values are the denominators for the percentage calculations.
c. If no data for temperature, local reactions, fever/pain medication, or systemic events are reported for the entire electronic diary (e -diary) or AE collection
period ( page for Day 1 through Day 7 ), after vaccination, the e -diary is considered not transmitted.
d. If any data for temperature, local reactions, fever/pain medication, or systemic events are reported for the specified day or set of days (ie, "all 7 days"), the
e-diary is considered t ransmitted.
e. "All 7 days" includes Day 1 through Day 7 after vaccination. Day 1 is the day of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:2229APR2021 (21:11) Source Data: adfacevd Table Generation: 27MAR2021
(01:55 25JAN2022 (02:18)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA_Peds_EDIARY /adce_s200_trns_ped_saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492647
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Local
Reaction Na nb (%) (95% CIc
) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
1 Rednessd
Any 1127 65 (5.8) (4.5, 7.3) 531 34 (6.4) (4.5, 8.8) 1127 12 (1.1) (0.6, 1.9) 55
3 5 (0.97 (1.3) (0.35, 2.16)
Mild 1127 44 (3.9) (2.9, 5.2) 531 25 (4.7) (3.1, 6.9) 1127 11 (1.0) (0.5, 1.7) 55
3 4 (0.76 (1.1) (0.4, 2, 1.8.
3)
Mod
erate 1127 20 (1.8) (1.1, 2.7) 531 7 (1.3) (0.5, 2.7) 1127 1 (0.1) (0.0, 0.5) 55
3 1 (0.2) (0.0, 1.0)
Sever
e 1127 1 (0.1) (0.0, 0.5) 531 2 (0.4) (0.0, 1.4) 1127 0 (0.0, 0.3) 55
3 0 (0.0, 0.7)
Grad
e 4 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 55
3 0 (0.0, 0.7)
Swellingd
Any 1127 78 (6.9) (5.5, 8.6) 531 44 (8.3) (6.1, 11.0) 1127 11 (1.0) (0.5, 1.7) 55
3 6 (1.1) (0.4, 2.3)
Mild 1127 55 (4.9) (3.7, 6.3) 531 31 (5.8) (4.0, 8.2) 1127 9 (0.8) (0.4, 1.5) 55
3 3 (0.5) (0.1, 1.6)
Mod
erate 1127 23 (2.0) (1.3, 3.0) 531 12 (2.3) (1.2, 3.9) 1127 2 (0.2) (0.0, 0.6) 55
3 3 (0.5) (0.1, 1.6)
Sever
e 1127 0 (0.0, 0.3) 531 1 (0.2) (0.0, 1.0) 1127 0 (0.0, 0.3) 55
3 0 (0.0, 0.7)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492648
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Local
Reaction Na nb (%) (95% CIc
) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grad
e 4 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 55
3 0 (0.0, 0.7)
Pain at the
injection
sitee
Any 1127 971973 (86.23) (84.02, 88
.13) 5315
32 443444 (83.45
) (80.0, 86.5) 1127 263267 (23.37
) (20.9, 25.921.2,
26.3) 55
3 88 (15.9) (13.0, 19.2)
Mild 1127 467469 (41.46) (38.57, 44
.46) 5315
32 204203 (38.42
) (34.30, 42.74
) 1127 227231 (20.15
) (17.8, 22.618.2,
23.0) 55
3 81 (14.6) (11.8, 17.9)
Mod
erate 1127 493 (43.7) (40.8, 46.
7) 5315
32 227 (42.7 229
(43.0 ) (38.58, 47.14
) 1127 36 (3.2) (2.2, 4.4) 55
3 7 (1.3) (0.5, 2.6)
Sever
e 1127 11 (1.0) (0.5, 1.7) 5315
32 12 (2.3) (1.2, 3.9) 1127 0 (0.0, 0.3) 55
3 0 (0.0, 0.7)
Grad
e 4 1127 0 (0.0, 0.3) 5315
32 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 55
3 0 (0.0, 0.7)
Any local
reactionf 1127 976978 (86.68) (84.57, 88
.57) 5315
32 445446 (83.8) (80.4, 86.89) 1127 271275 (24.04
) (21.6, 26.79, 27
.0) 55
3 9193 (16.58) (13.5, 19.8,
20.2)
2 Rednessd
Any 1097 55 (5.0) (3.8, 6.5) 488 28 (5.7) (3.8, 8.2) 1078 10 (0.9) (0.4, 1.7) 49
6 1 (0.2) (0.0, 1.1)
Mild 1097 29 (2.6) (1.8, 3.8) 488 18 (3.7) (2.2, 5.8) 1078 8 (0.7) (0.3, 1.5) 49
6 1 (0.2) (0.0, 1.1)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492649
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Local
Reaction Na nb (%) (95% CIc
) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mod
erate 1097 26 (2.4) (1.6, 3.5) 488 9 (1.8) (0.8, 3.5) 1078 2 (0.2) (0.0, 0.7) 49
6 0 (0.0, 0.7)
Sever
e 1097 0 (0.0, 0.3) 488 1 (0.2) (0.0, 1.1) 1078 0 (0.0, 0.3) 49
6 0 (0.0, 0.7)
Grad
e 4 1097 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 49
6 0 (0.0, 0.7)
Swellingd
Any 1097 1
098 54 (4.955 (5.0) (3.78, 6.4
5) 4884
89 33 (6.834 (7.0
) (4.7, 9.4, 9.6) 1078 6 (0.6) (0.2, 1.2) 49
6 1 (0.2) (0.0, 1.1)
Mild 1097 1
098 36 (3.3) (2.3, 4.5) 4884
89 2324 (4.79) (3.02, 7.02) 1078 4 (0.4) (0.1, 0.9) 49
6 1 (0.2) (0.0, 1.1)
Mod
erate 1097 1
098 1819 (1.67) (1.0, 2.67
) 4884
89 10 (2.0) (1.0, 3.7) 1078 2 (0.2) (0.0, 0.7) 49
6 0 (0.0, 0.7)
Sever
e 1097 1
098 0 (0.0, 0.3) 4884
89 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 49
6 0 (0.0, 0.7)
Grad
e 4 1097 1
098 0 (0.0, 0.3) 4884
89 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 49
6 0 (0.0, 0.7)
Pain at the
injection
sitee
Any 1097 1
101 866 (78.9 870 (7
9.0) (76.45, 81
.34) 4884
90 378380 (77.56
) (73.56, 81.12
) 1078 1
079 193 (17.9 194
(18.0 ) (15.7, 20.34) 49
6 6061 (12.13) (9.45, 15.35
)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492650
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Local
Reaction Na nb (%) (95% CIc
) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 1097 1
101 466467 (42.54) (39.5, 45.
54) 4884
90 202204 (41.46
) (37.0, 45.92,
46.1) 1078 1
079 164165 (15.23
) (13.12, 17.56) 49
6 5354 (10.79) (8.1, 13.73,
14.0)
Mod
erate 1097 1
101 393 (35.8 396 (3
6.0) (33.01, 38
.79) 4884
90 169 (34.65) (30.4, 39.03,
38.9) 1078 1
079 29 (2.7) (1.8, 3.8) 49
6 7 (1.4) (0.6, 2.9)
Sever
e 1097 1
101 7 (0.6) (0.3, 1.3) 4884
90 7 (1.4) (0.6, 2.9) 1078 1
079 0 (0.0, 0.3) 49
6 0 (0.0, 0.7)
Grad
e 4 1097 1
101 0 (0.0, 0.3) 4884
90 0 (0.0, 0.8) 1078 1
079 0 (0.0, 0.3) 49
6 0 (0.0, 0.7)
Any local
reactionf 1097 1
101 872876 (79.56) (77.01, 81
.89) 4884
90 381383 (78.12
) (74.12, 81.7) 1078 1
079 198199 (18.4) (16.12, 20.89) 49
6 6263 (12.57) (9.7, 15.79,
16.0)
An
y
dos
e Rednessd
Any 1131 97 (8.6) (7.0, 10.4
) 535 55 (10.3) (7.8, 13.2) 1129 18 (1.6) (0.9, 2.5) 55
5 5 (0.97 (1.3) (0.35, 2.16)
Mild 1131 55 (4.9) (3.7, 6.3) 535 37 (6.9) (4.9, 9.4) 1129 15 (1.3) (0.7, 2.2) 55
5 4 (0.76 (1.1) (0.4, 2, 1.8.
3)
Mod
erate 1131 41 (3.6) (2.6, 4.9) 535 15 (2.8) (1.6, 4.6) 1129 3 (0.3) (0.1, 0.8) 55
5 1 (0.2) (0.0, 1.0)
Sever
e 1131 1 (0.1) (0.0, 0.5) 535 3 (0.6) (0.1, 1.6) 1129 0 (0.0, 0.3) 55
5 0 (0.0, 0.7)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492651
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Local
Reaction Na nb (%) (95% CIc
) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grad
e 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 55
5 0 (0.0, 0.7)
Swellingd
Any 1131 104 (9.2) (7.6, 11.0
) 535 6162 (11.46) (8.89.0, 14.4
6) 1129 13 (1.2) (0.6, 2.0) 55
5 7 (1.3) (0.5, 2.6)
Mild 1131 6968 (6.10) (4.8, 7., 7.
6) 535 4445 (8.24) (6.0, 10.92, 1
1.1) 1129 10 (0.9) (0.4, 1.6) 55
5 4 (0.7) (0.2, 1.8)
Mod
erate 1131 3536 (3.12) (2.2, 4.34
) 535 16 (3.0) (1.7, 4.8) 1129 3 (0.3) (0.1, 0.8) 55
5 3 (0.5) (0.1, 1.6)
Sever
e 1131 0 (0.0, 0.3) 535 1 (0.2) (0.0, 1.0) 1129 0 (0.0, 0.3) 55
5 0 (0.0, 0.7)
Grad
e 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 55
5 0 (0.0, 0.7)
Pain at the
injection
sitee
Any 1131 1023 1024 (90.5
) (88.67, 92
.12) 535 468 (87.5) (84.4, 90.2) 1129 341344 (30.25
) (27.58, 33.02) 55
5 121 (21.8 122
(22.0 ) (18.46, 25.5
7)
Mild 1131 394393 (34.87) (32.10, 37
.76) 535 168167 (31.42
) (27.53, 35.53
) 1129 283286 (25.13
) (22.6, 27.78, 28
.0) 55
5 108109 (19.56
) (16.24, 23.0
2)
Mod
erate 1131 612614 (54.13) (51.23, 57
.02) 535 282283 (52.79
) (48.46, 57.02
) 1129 58 (5.1) (3.9, 6.6) 55
5 13 (2.3) (1.3, 4.0)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492652
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Local
Reaction Na nb (%) (95% CIc
) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Sever
e 1131 17 (1.5) (0.9, 2.4) 535 18 (3.4) (2.0, 5.3) 1129 0 (0.0, 0.3) 55
5 0 (0.0, 0.7)
Grad
e 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 55
5 0 (0.0, 0.7)
Any local
reactionf 1131 1028 (90.9 1029
(91.0 ) (89.12, 92
.56) 535 471 (88.0) (85.0, 90.7) 1129 349 (30.9 352
(31.2 ) (28.2, 33.75, 34
.0) 55
5 125127 (22.59
) (19.15, 26.2
6)
Note: Reactions were collected in the electronic diary (e -diary) from Day 1 through Day 7 after each dose.
Note: Grade 4 reactions were classified by the investigator or medically qualified person.
a. N = number of subjects reporting at least 1 yes or no response for the specified reaction after the specified dose.
b. n = Number of subjects with the s pecified characteristic.
c. Exact 2 -sided CI based on the Clopper and Pearson method.
d. Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exf oliative dermatitis (redness
category only).
e. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization
for severe pain at the injection site.
f. Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:2229APR2021 (21:11) Source Data: adfacevd Table Generation: 27MAR2021
(01:55 21JAN2022 (09:17)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_s010_lr_sev_ped_saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492653
Duration (Days) From First to Last Day of Local Reactions –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Local Reaction 12-15 Years 16-25 Years 12-15 Years 16-25 Years
1 Redness
na 65 34 12 57
Mean (SD) 2.4 (2.26) 1.8 (0.97) 1.3 (0.62) 1.23 (0.4549)
Median 2.0 2.0 1.0 1.0
Min, max (1, 16) (1, 5) (1, 3) (1, 2)
Swelling
na 78 44 11 6
Mean (SD) 1.9 (1.10) 2.0 (1.50) 1.7 (1.35) 1.3 (0.82)
Median 2.0 1.0 1.0 1.0
Min, max (1, 5) (1, 7) (1, 5) (1, 3)
Pain at the injection site
na 971973 443444 263267 88
Mean (SD) 2.4 (1.35) 2.3 (1.37) 2.0 (1. 7573) 1.5 (1.27)
Median 2.0 2.0 1.0 1.0
Min, max (1, 10) (1, 9) (1, 10) (1, 11)
2 Redness
na 55 28 10 1
Mean (SD) 1.8 (0.88) 1.9 (1.43) 1.7 (1.16) 1.0 (NE)
Median 2.0 1.5 1.0 1.0
Min, max (1, 5) (1, 8) (1, 4) (1, 1)
Unknownb 1 0 0 0
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492654
Duration (Days) From First to Last Day of Local Reactions –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Local Reaction 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Swelling
na 5455 3334 6 1
Mean (SD) 1.67 (0.93) 2.23 (1.69) 1.5 (0.55) 3.0 (NE)
Median 1.0 2.0 1.5 3.0
Min, max (1, 5) (1, 7) (1, 2) (3, 3)
Pain at the injection site
na 866870 378380 193194 6061
Mean (SD) 2.5 (1.38) 2.8 (4. 3130) 1.8 (1. 4443) 2.2 (4. 4542)
Median 2.0 2.0 1.0 1.0
Min, max (1, 11) (1, 70) (1, 8) (1, 35)
Unknownb 3 3 0 0
Abbreviation: NE = not estimable.
Note: Duration was calculated in days as the difference from the start of the first reported reaction to the resolution of th e last reported reaction, inclusive. For
symptoms that are ongoing at the time of the next dose, stop date is computed as the next dose date.
Note: Reactions were recorded in the electronic diary (e -diary) from Day 1 through Day 7 after each dose. The resolution date for reactions lasting longer than
7 days was recorded on the subject's case report form.
a. n = Number of subjects reporting the specified reaction on any of the 7 days, including subjects with reactions of unknown duration.
b. Includes those reactions where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:19 29APR2021 (21:06) Source Data: adcevd Table Generation: 27MAR2021 (01:29 21JAN2022
(09:17 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA sBLA Peds EDIARY /adce s030 lr dur ped saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492655
Onset Days for Local Reactions – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Popul ation
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Local Reaction 12-15 Years 16-25 Years 12-15 Years 16-25 Years
1 Redness
na 65 34 12 57
Mean (SD) 2.4 (0.82) 2.4 (1.05) 1.8 (1.11) 1.86 (1.3013)
Median 2.0 2.0 1.5 1.0
Min, max (1, 4) (1, 5) (1, 4) (1, 4)
Swelling
na 78 44 11 6
Mean (SD) 1.9 (0.85) 2.2 (1.02) 1.6 (1.21) 1.3 (0.82)
Median 2.0 2.0 1.0 1.0
Min, max (1, 5) (1, 5) (1, 4) (1, 3)
Pain at the injection site
na 971973 443444 263267 88
Mean (SD) 1.4 (0.55) 1.4 (0. 5150) 1.3 (0. 8483) 1.5 (1.05)
Median 1.0 1.0 1.0 1.0
Min, max (1, 7) (1, 4) (1, 7) (1, 7)
Any local reactionb
na 976978 445446 271275 9193
Mean (SD) 1.4 (0.56) 1.4 (0.51) 1.4 (0.87) 1.5 (1. 0605)
Median 1.0 1.0 1.0 1.0
Min, max (1, 7) (1, 4) (1, 7) (1, 7)
2 Redness
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492656
Onset Days for Local Reactions – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Popul ation
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Local Reaction 12-15 Years 16-25 Years 12-15 Years 16-25 Years
na 55 28 10 1
Mean (SD) 2.5 (0.84) 2.6 (0.79) 1.2 (0.42) 1.0 (NE)
Median 2.0 3.0 1.0 1.0
Min, max (1, 5) (1, 4) (1, 2) (1, 1)
Swelling
na 5455 3334 6 1
Mean (SD) 2.10 (0.96) 2.0 (0. 9897) 2.8 (2.86) 3.0 (NE)
Median 2.0 2.0 1.0 3.0
Min, max (1, 4) (1, 4) (1, 7) (3, 3)
Pain at the injection site
na 866870 378380 193194 6061
Mean (SD) 1.4 (0.61) 1.4 (0.62) 1.5 (1. 1413) 1.6 (1. 0605)
Median 1.0 1.0 1.0 1.0
Min, max (1, 6) (1, 6) (1, 7) (1, 6)
Any local reactionb
na 872876 381383 198199 6263
Mean (SD) 1.4 (0.62) 1.4 (0.63) 1.5 (1.08) 1.6 (1. 0605)
Median 1.0 1.0 1.0 1.0
Min, max (1, 6) (1, 6) (1, 7) (1, 6)
Abbreviation: NE = not estimable.
Note: Day of onset is the first day the specified reaction was reported.
a. n = Number of subjects reporting the specified reaction, with each subject counted only once per reaction.
b. Any local reaction: any r edness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site.
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492657
Onset Days for Local Reactions – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Popul ation
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Local Reaction 12-15 Years 16-25 Years 12-15 Years 16-25 Years
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22 29APR2021 (21:11 ) Source Data: adfacevd Table Generation: 27MAR2021
(01:55 21JAN2022 (09:17)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_s050_lr_onset_ped_saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492658
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
1 Fever
≥38.0°C A
ny 1127 114 (10.1) (8.4, 12.0) 531 39 (7.3) (5.3, 9.9) 1127 12 (1.1) (0.6, 1.9) 553 8 (1.4) (0.6, 2.8)
≥38.0°C to
38.4°C 1127 74 (6.6) (5.2, 8.2) 531 24 (4.5) (2.9, 6.7) 1127 8 (0.7) (0.3, 1.4) 553 5 (0.9) (0.3, 2.1)
>38.4°C to
38.9°C 1127 29 (2.6) (1.7, 3.7) 531 12 (2.3) (1.2, 3.9) 1127 2 (0.2) (0.0, 0.6) 553 2 (0.4) (0.0, 1.3)
>38.9°C to
40.0°C 1127 10 (0.9) (0.4, 1.6) 531 3 (0.6) (0.1, 1.6) 1127 2 (0.2) (0.0, 0.6) 553 1 (0.2) (0.0, 1.0)
>40.0°C 1127 1 (0.1) (0.0, 0.5) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Unknownd 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Fatigued
Fatiguee
Any 1127 677678 (60.1
2) (57.1, 62.92, 6
3.0) 5315
32 318 (59.9 319
(60.0 ) (55.67, 64.12) 1127 457 (40.6) (37.7, 43.5) 553 213 (38.5) (34.4, 42.7)
Mild 1127 278279 (24.7
8) (22.23, 27.34) 5315
32 134135 (25.2
4) (21.67, 29.23) 1127 250 (22.2) (19.8, 24.7) 553 118 (21.3) (18.0, 25.0)
Moderate 1127 384 (34.1) (31.3, 36.9) 5315
32 173 (32.65) (28.6, 36.7) 1127 199 (17.7) (15.5, 20.0) 553 89 (16.1) (13.1, 19.4)
Severe 1127 15 (1.3) (0.7, 2.2) 5315
32 11 (2.1) (1.0, 3.7) 1127 8 (0.7) (0.3, 1.4) 553 6 (1.1) (0.4, 2.3)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492659
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 1127 0 (0.0, 0.3) 5315
32 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
HeadachedHead
achee
Any 1127 623624 (55.3
4) (52.34, 58.23) 5315
33 286 (53.9 288
(54.0 ) (49.57, 58.23) 1127 396 (35.1) (32.3, 38.0) 553 205 (37.1) (33.0, 41.2)
Mild 1127 361362 (32.0
1) (29.34, 34.89) 5315
33 151153 (28.4
7) (24.69, 32.58) 1127 256 (22.7) (20.3, 25.3) 553 138 (25.0) (21.4, 28.8)
Moderate 1127 251 (22.3) (19.9, 24.8) 5315
33 124 (23.43) (19.87, 27.21) 1127 131 (11.6) (9.8, 13.6) 553 63 (11.4) (8.9, 14.3)
Severe 1127 11 (1.0) (0.5, 1.7) 5315
33 11 (2.1) (1.0, 3.7) 1127 9 (0.8) (0.4, 1.5) 553 4 (0.7) (0.2, 1.8)
Grade 4 1127 0 (0.0, 0.3) 5315
33 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
ChillsdChillse
Any 1127 311312 (27.6
7) (25.01, 30.34) 5315
32 133134 (25.0
2) (21.46, 29.01) 1127 109 (9.7) (8.0, 11.5) 553 47 (8.5) (6.3, 11.1)
Mild 1127 195 (17.3) (15.1, 19.6) 5315
32 91 (17.1) (14.0, 20.6) 1127 82 (7.3) (5.8, 9.0) 553 31 (5.6) (3.8, 7.9)
Moderate 1127 111112 (9.89
) (8.23, 11.78) 5315
32 3738 (7.01) (5.01, 9.57) 1127 25 (2.2) (1.4, 3.3) 553 15 (2.7) (1.5, 4.4)
Severe 1127 5 (0.4) (0.1, 1.0) 5315
32 5 (0.9) (0.3, 2.2) 1127 2 (0.2) (0.0, 0.6) 553 1 (0.2) (0.0, 1.0)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492660
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 1127 0 (0.0, 0.3) 5315
32 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
VomitingeVomi
tingf
Any 1127 31 (2.8) (1.9, 3.9) 531 9 (1.7) (0.8, 3.2) 1127 10 (0.9) (0.4, 1.6) 553 9 (1.6) (0.7, 3.1)
Mild 1127 30 (2.7) (1.8, 3.8) 531 9 (1.7) (0.8, 3.2) 1127 8 (0.7) (0.3, 1.4) 553 8 (1.4) (0.6, 2.8)
Moderate 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 2 (0.2) (0.0, 0.6) 553 0 (0.0, 0.7)
Severe 1127 1 (0.1) (0.0, 0.5) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 1 (0.2) (0.0, 1.0)
Grade 4 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
DiarrheafDiarrh
eag
Any 1127 90 (8.0) (6.5, 9.7) 531 57 (10.7) (8.2, 13.7) 1127 8283 (7.34) (5.89, 9.0) 553 62 (11.2) (8.7, 14.1)
Mild 1127 77 (6.8) (5.4, 8.5) 531 50 (9.4) (7.1, 12.2) 1127 7273 (6.45) (5.01, 8.01) 553 49 (8.9) (6.6, 11.5)
Moderate 1127 13 (1.2) (0.6, 2.0) 531 7 (1.3) (0.5, 2.7) 1127 10 (0.9) (0.4, 1.6) 553 13 (2.4) (1.3, 4.0)
Severe 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Grade 4 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
New or
worsened
muscle
paindpaine
Any 1127 272 (24.1) (21.7, 26.7) 5315
32 143 (26.9 144
(27.1 ) (23.2, 30.93, 3
1.1) 1127 148 (13.1) (11.2, 15.2) 553 78 (14.1) (11.3, 17.3)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492661
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 1127 125 (11.1) (9.3, 13.1) 5315
32 67 (12.6) (9.9, 15.7) 1127 88 (7.8) (6.3, 9.5) 553 51 (9.2) (6.9, 11.9)
Moderate 1127 145 (12.9) (11.0, 15.0) 5315
32 7172 (13.45) (10.67, 16.67) 1127 60 (5.3) (4.1, 6.8) 553 27 (4.9) (3.2, 7.0)
Severe 1127 2 (0.2) (0.0, 0.6) 5315
32 5 (0.9) (0.3, 2.2) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Grade 4 1127 0 (0.0, 0.3) 5315
32 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
New or
worsened joint
paindpaine
Any 1127 109 (9.7) (8.0, 11.5) 531 70 (13.2) (10.4, 16.4) 1127 77 (6.8) (5.4, 8.5) 553 28 (5.1) (3.4, 7.2)
Mild 1127 66 (5.9) (4.6, 7.4) 531 38 (7.2) (5.1, 9.7) 1127 50 (4.4) (3.3, 5.8) 553 17 (3.1) (1.8, 4.9)
Moderate 1127 42 (3.7) (2.7, 5.0) 531 29 (5.5) (3.7, 7.7) 1127 27 (2.4) (1.6, 3.5) 553 11 (2.0) (1.0, 3.5)
Severe 1127 1 (0.1) (0.0, 0.5) 531 3 (0.6) (0.1, 1.6) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Grade 4 1127 0 (0.0, 0.3) 531 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Any systemic
eventgeventh 1127 877878 (77.8
9) (75.34, 80.23) 5315
33 403 (75.9 405
(76.0 ) (72.01, 79.56) 1127 636637 (56
.45) (53.56, 59.4) 553 311 (56.2) (52.0, 60.4)
Use of
antipyretic or
pain 1127 413 (36.6) (33.8, 39.5) 531 167 (31.5) (27.5, 35.6) 1127 111 (9.8) (8.2, 11.7) 553 62 (11.2) (8.7, 14.1)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492662
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
medicationhme
dicationi
2 Fever
≥38.0°C A
ny 1097 1
098 215217 (19.6
8) (17.34, 22.12) 4884
89 84 (17.2 88 (1
8.0) (14.0, 20.97, 2
1.7) 1078 7 (0.6) (0.3, 1.3) 496 2 (0.4) (0.0, 1.4)
≥38.0°C to
38.4°C 1097 1
098 107 (9.87) (8.1, 11.7) 4884
89 45 (9.2) (6.8, 12.1) 1078 5 (0.5) (0.2, 1.1) 496 1 (0.2) (0.0, 1.1)
>38.4°C to
38.9°C 1097 1
098 83 (7.6) (6.1, 9.3) 4884
89 32 (6.65) (4.5, 9.1) 1078 1 (0.1) (0.0, 0.5) 496 0 (0.0, 0.7)
>38.9°C to
40.0°C 1097 1
098 25 (2.3) (1.5, 3.3) 4884
89 7 (1.4) (0.6, 2.9) 1078 1 (0.1) (0.0, 0.5) 496 1 (0.2) (0.0, 1.1)
>40.0°C 1097 1
098 0 (0.0, 0.3) 4884
89 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Unknownd 1098 2 (0.2) (0.0, 0.7) 489 4 (0.8) (0.2, 2.1) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Fatiguee
Any 1101 732 (66.5) (63.6, 69.3) 490 323 (65.9) (61.5, 70.1) 1079 265 (24.6) (22.0, 27.2) 496 116 (23.4) (19.7, 27.4)
Mild 1101 234 (21.3) (18.9, 23.8) 490 100 (20.4) (16.9, 24.3) 1079 134 (12.4) (10.5, 14.5) 496 52 (10.5) (7.9, 13.5)
Moderate 1101 472 (42.9) (39.9, 45.9) 490 200 (40.8) (36.4, 45.3) 1079 127 (11.8) (9.9, 13.8) 496 62 (12.5) (9.7, 15.7)
Severe 1101 26 (2.4) (1.5, 3.4) 490 23 (4.7) (3.0, 7.0) 1079 4 (0.4) (0.1, 0.9) 496 2 (0.4) (0.0, 1.4)
Grade 4 1101 0 (0.0, 0.3) 490 0 (0.0, 0.8) 1079 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Headachee
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492663
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 1099 710 (64.6) (61.7, 67.4) 490 300 (61.2) (56.8, 65.6) 1078 263 (24.4) (21.9, 27.1) 496 118 (23.8) (20.1, 27.8)
Mild 1099 302 (27.5) (24.9, 30.2) 490 121 (24.7) (20.9, 28.8) 1078 169 (15.7) (13.6, 18.0) 496 67 (13.5) (10.6, 16.8)
Moderate 1099 386 (35.1) (32.3, 38.0) 490 158 (32.2) (28.1, 36.6) 1078 93 (8.6) (7.0, 10.5) 496 46 (9.3) (6.9, 12.2)
Severe 1099 22 (2.0) (1.3, 3.0) 490 21 (4.3) (2.7, 6.5) 1078 1 (0.1) (0.0, 0.5) 496 5 (1.0) (0.3, 2.3)
Grade 4 1099 0 (0.0, 0.3) 490 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
FatiguedChillse
Any 1097 726 (66.2 455
(41.5 ) (63.3, 69.038.
5, 44.5) 4884
89 320 (65.6 196
(40.1 ) (61.2, 69.835.
7, 44.6) 1078 1
079 264 (24.5 7
4 (6.9) (21.9, 27.25.
4, 8.5) 496 115 (23.2 2
2 (4.4) (19.5, 27.2.
8, 6.6)
Mild 1097 232 (21221 (
20.1) (1817.8, 23.72
2.6) 4884
89 98 (20.1 82 (1
6.8) (1613.6, 23.92
0.4) 1078 1
079 133 (12.3 5
3 (4.9) (103.7, 6.4,
14.5) 496 51 (10.17 (
3.4) (7.8, 13.32.
0, 5.4)
Moderate 1097 468 (42.7 214
(19.5 ) (39.7, 45.717.
2, 22.0) 4884
89 199 (40.8 102
(20.9 ) (36.4, 4517.3,
24.7) 1078 1
079 127 (11.8 2
1 (1.9) (9.9, 13.91.2
, 3.0) 496 62 (12.5 (1.
0) (9.7, 15.70.
3, 2.3)
Severe 1097 26 (2.420 (1.
8) (1.6, 3.51, 2.8) 4884
89 23 (4.712 (2.
5) (1.3.0, 7.0, 4.2
) 1078 1
079 4 (0.4) (0.1, 0.9, 0.3
) 496 2 (0.4) (0.0, 1.40.7
)
Grade 4 1097 0 (0.0, 0.3) 4884
89 0 (0.0, 0.8) 1078 1
079 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Vomitingf
Any 1098 30 (2.7) (1.9, 3.9) 488 13 (2.7) (1.4, 4.5) 1078 12 (1.1) (0.6, 1.9) 496 9 (1.8) (0.8, 3.4)
Mild 1098 26 (2.4) (1.6, 3.5) 488 10 (2.0) (1.0, 3.7) 1078 11 (1.0) (0.5, 1.8) 496 5 (1.0) (0.3, 2.3)
Moderate 1098 4 (0.4) (0.1, 0.9) 488 3 (0.6) (0.1, 1.8) 1078 1 (0.1) (0.0, 0.5) 496 4 (0.8) (0.2, 2.1)
Severe 1098 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492664
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Do
se Systemic
Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 1098 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
HeadachedDiarr
heag
Any 1097 1
098 708 (64.5 67 (
6.1) (61.6, 67.4.8,
7.7) 488 297 (60.9 39 (
8.0) (56.4, 65.25.7,
10.8) 1078 263 (24.43
(4.0) (212.9, 27.1
5.3) 4964
97 118 (23.8 2
7 (5.4) (20.1, 273.6
, 7.8)
Mild 1097 1
098 302 (27.59 (5
.4) (244.1, 6.9, 30
.3) 488 119 (24.4 32 (
6.6) (20.6, 28.4.5,
9.1) 1078 169 (15.7 3
8 (3.5) (13.6, 18.02.
5, 4.8) 4964
97 67 (13.5 22
(4.4) (10.6, 162.8
, 6.6)
Moderate 1097 384 (35.0) (32.2, 37.9) 488 157 (32.2) (28.0, 36.5) 1078 93 (8.6) (7.0, 10.5) 496 46 (9.3) (6.9, 12.2)
Severe Moderate 1097 1098 22 (2.8 (0.7) (10.3, 3.01.4) 488 21 (4.35 (1.0) (0.3, 2.7, 6.54) 1078 15 (0.15) (0.0, 0.52, 1.1) 496497 5 (1.0) (0.3, 2.3)
Grade 4 Severe 1097 1098 0 (0.0, 0.3) 488 2 (0.4) (0.0, 0.81.5) 1078 0 (0.0, 0.3) 496497 0 (0.0, 0.7)
Chillsd
Any 1097 455 (41.5) (38.5, 44.5) 488 195 (40.0) (35.6, 44.5) 1078 73 (6.8) (5.3, 8.4) 496 22 (4.4) (2.8, 6.6)
Mild 1097 221 (20.1) (17.8, 22.6) 488 82 (16.8) (13.6, 20.4) 1078 52 (4.8) (3.6, 6.3) 496 17 (3.4) (2.0, 5.4)
Moderate 1097 214 (19.5) (17.2, 22.0) 488 101 (20.7) (17.2, 24.6) 1078 21 (1.9) (1.2, 3.0) 496 5 (1.0) (0.3, 2.3)
Severe 1097 20 (1.8) (1.1, 2.8) 488 12 (2.5) (1.3, 4.3) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Grade 4 1097 1098 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496497 0 (0.0, 0.7)
Vomitinge
Any 1097 29 (2.6) (1.8, 3.8) 488 13 (2.7) (1.4, 4.5) 1078 12 (1.1) (0.6, 1.9) 496 9 (1.8) (0.8, 3.4)
Mild 1097 25 (2.3) (1.5, 3.3) 488 10 (2.0) (1.0, 3.7) 1078 11 (1.0) (0.5, 1.8) 496 5 (1.0) (0.3, 2.3)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492665
Moderate 1097 4 (0.4) (0.1, 0.9) 488 3 (0.6) (0.1, 1.8) 1078 1 (0.1) (0.0, 0.5) 496 4 (0.8) (0.2, 2.1)
Severe 1097 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Grade 4 1097 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Diarrheaf
Any 1097 65 (5.9) (4.6, 7.5) 488 39 (8.0) (5.7, 10.8) 1078 43 (4.0) (2.9, 5.3) 496 26 (5.2) (3.5, 7.6)
Mild 1097 59 (5.4) (4.1, 6.9) 488 32 (6.6) (4.5, 9.1) 1078 38 (3.5) (2.5, 4.8) 496 21 (4.2) (2.6, 6.4)
Moderate 1097 6 (0.5) (0.2, 1.2) 488 5 (1.0) (0.3, 2.4) 1078 5 (0.5) (0.2, 1.1) 496 5 (1.0) (0.3, 2.3)
Severe 1097 0 (0.0, 0.3) 488 2 (0.4) (0.0, 1.5) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Grade 4 1097 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
New or
worsened
muscle
paindpaine
Any 1097 1
098 355358 (32.4
6) (29.68, 35.25) 4884
89 199 (40.8 201
(41.1 ) (36.47, 45.36) 1078 9091 (8.34
) (6.89, 10.
23) 496 48 (9.7) (7.2, 12.6
)
Mild 1097 1
098 152 (13.9 154
(14.0 ) (11.912.0, 16.0
2) 4884
89 9394 (19.12) (15.7, 22.8, 23.
0) 1078 5152 (4.78
) (3.5, 6.2,
6.3) 496 29 (5.8) (4.0, 8.3)
Moderate 1097 1
098 197198 (18.0) (15.78, 20.4) 4884
89 97 (19.9 98 (2
0.0) (16.46, 23.79) 1078 37 (3.4) (2.4, 4.7) 496 18 (3.6) (2.2, 5.7)
Severe 1097 1
098 6 (0.5) (0.2, 1.2) 4884
89 9 (1.8) (0.8, 3.5) 1078 2 (0.2) (0.0, 0.7) 496 1 (0.2) (0.0, 1.1)
Grade 4 1097 1
098 0 (0.0, 0.3) 4884
89 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
New or
worsened joint
paindpaine
Any 1097 173 (15.8) (13.7, 18.1) 4884
89 107 (21.9 108
(22.1 ) (18.3, 25.95, 2
6.0) 1078 51 (4.7) (3.5, 6.2) 496 20 (4.0) (2.5, 6.2)
Mild 1097 91 (8.3) (6.7, 10.1) 4884
89 4950 (10.02) (7.57, 13.13) 1078 30 (2.8) (1.9, 3.9) 496 14 (2.8) (1.6, 4.7)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492666
Moderate 1097 78 (7.1) (5.7, 8.8) 4884
89 54 (11.10) (8.4, 14.2) 1078 21 (1.9) (1.2, 3.0) 496 6 (1.2) (0.4, 2.6)
Severe 1097 4 (0.4) (0.1, 0.9) 4884
89 4 (0.8) (0.2, 2.1) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Grade 4 1097 0 (0.0, 0.3) 4884
89 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Any systemic
eventgeventh 1097 1
101 904910 (82.4
7) (80.03, 84.68) 4884
92 396400 (81.1
3) (77.46, 84.57) 1078 1
079 439441 (4
0.79) (37.89, 4
3.79) 4964
97 183 (36.9 184
(37.0 ) (32.68, 41
.34)
Use of
antipyretic or
pain
medicationhmed
icationi 1097 557 (50.8) (47.8, 53.8) 488 223 (45.7) (41.2, 50.2) 1078 95 (8.8) (7.2, 10.7
) 496 59 (11.9) (9.2, 15.1
)
An
y
do
se Fever
≥38.0°C An
y 1131 275277 (24.3
5) (21.8, 26.922.0
, 27.1) 535 113117 (21.1
9) (17.7, 24.818.4
, 25.6) 1129 17 (1.5) (0.9, 2.4) 555 9 (1.6) (0.7, 3.1)
≥38.0°C to
38.4°C 1131 141 (12.5) (10.6, 14.5) 535 63 (11.8) (9.2, 14.8) 1129 11 (1.0) (0.5, 1.7) 555 6 (1.1) (0.4, 2.3)
>38.4°C to
38.9°C 1131 100 (8.8) (7.3, 10.6) 535 40 (7.5) (5.4, 10.0) 1129 3 (0.3) (0.1, 0.8) 555 2 (0.4) (0.0, 1.3)
>38.9°C to
40.0°C 1131 33 (2.9) (2.0, 4.1) 535 10 (1.9) (0.9, 3.4) 1129 3 (0.3) (0.1, 0.8) 555 1 (0.2) (0.0, 1.0)
>40.0°C 1131 1 (0.1) (0.0, 0.5) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
Unknownd 1131 2 (0.2) (0.0, 0.6) 535 4 (0.7) (0.2, 1.9) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
Fatigued
Fatiguee
Any 1131 876879 (77.5
7) (74.9, 79.975.2
, 80.1) 535 403 (75.3) (71.4, 78.9) 1129 538 (47.7) (44.7, 50.
6) 555 240 (43.2) (39.1, 47.
5)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492667
Mild 1131 239240 (21.1
2) (18.89, 23.67) 535 104 (19.4) (16.2, 23.1) 1129 266 (23.6) (21.1, 26.
1) 555 114 (20.5) (17.3, 24.
1)
Moderate 1131 597 (52.8 599
(53.0 ) (49.850.0, 55.7
9) 535 267 (49.9) (45.6, 54.2) 1129 260 (23.0) (20.6, 25.
6) 555 119 (21.4) (18.1, 25.
1)
Severe 1131 40 (3.5) (2.5, 4.8) 535 32 (6.0) (4.1, 8.3) 1129 12 (1.1) (0.6, 1.8) 555 7 (1.3) (0.5, 2.6)
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
HeadachedHead
achee
Any 1131 854855 (75.5
6) (72.973.0, 78.0
1) 535 386387 (72.1
3) (68.3, 76.1, 75.
9) 1129 506 (44.8) (41.9, 47.
8) 555 243 (43.8) (39.6, 48.
0)
Mild 1131 324323 (28.6) (26.025.9, 31.4
3) 535 140141 (26.2
4) (22.57, 30.13) 1129 303 (26.8) (24.3, 29.
5) 555 147 (26.5) (22.9, 30.
4)
Moderate 1131 499501 (44.1
3) (41.24, 47.12) 535 216 (40.4) (36.2, 44.7) 1129 194 (17.2) (15.0, 19.
5) 555 87 (15.7) (12.8, 19.
0)
Severe 1131 31 (2.7) (1.9, 3.9) 535 30 (5.6) (3.8, 7.9) 1129 9 (0.8) (0.4, 1.5) 555 9 (1.6) (0.7, 3.1)
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
ChillsdChillse
Any 1131 557 (49.2) (46.3, 52.2) 535 256 (47.9 257
(48.0 ) (43.57, 52.24) 1129 159 (14.1) (12.1, 16.
3) 555 60 (10.8) (8.4, 13.7
)
Mild 1131 257 (22.7) (20.3, 25.3) 535 117 (21.9) (18.4, 25.6) 1129 114 (10.1) (8.4, 12.0
) 555 41 (7.4) (5.4, 9.9)
Moderate 1131 276 (24.4) (21.9, 27.0) 535 123124 (23.0
2) (19.5, 26.87, 2
7.0) 1129 43 (3.8) (2.8, 5.1) 555 18 (3.2) (1.9, 5.1)
Severe 1131 24 (2.1) (1.4, 3.1) 535 16 (3.0) (1.7, 4.8) 1129 2 (0.2) (0.0, 0.6) 555 1 (0.2) (0.0, 1.0)
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
VomitingeVomit
ingf
Any 1131 5960 (5.23) (4.01, 6.78) 535 21 (3.9) (2.4, 5.9) 1129 21 (1.9) (1.2, 2.8) 555 16 (2.9) (1.7, 4.6)
Mild 1131 5455 (4.89) (3.7, 6, 6.2.3) 535 18 (3.4) (2.0, 5.3) 1129 18 (1.6) (0.9, 2.5) 555 11 (2.0) (1.0, 3.5)
Moderate 1131 4 (0.4) (0.1, 0.9) 535 3 (0.6) (0.1, 1.6) 1129 3 (0.3) (0.1, 0.8) 555 4 (0.7) (0.2, 1.8)
Severe 1131 1 (0.1) (0.0, 0.5) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 1 (0.2) (0.0, 1.0)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492668
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
DiarrheafDiarrh
eag
Any 1131 141143 (12.5
6) (10.68, 14.57) 535 81 (15.1) (12.2, 18.5) 1129 106107 (9.
45) (7.8, 11.2
3) 555 7576 (13.57) (10.89, 16
.68)
Mild 1131 123 (10.9) (9.1, 12.8) 535 67 (12.5) (9.8, 15.6) 1129 9192 (8.1) (6.56, 9.8
9) 555 5758 (10.35) (7.98.0, 1
3.13)
Moderate 1131 1820 (1.68) (0.91.1, 2.57) 535 12 (2.2) (1.2, 3.9) 1129 15 (1.3) (0.7, 2.2) 555 18 (3.2) (1.9, 5.1)
Severe 1131 0 (0.0, 0.3) 535 2 (0.4) (0.0, 1.3) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
New or
worsened
muscle
paindpaine
Any 1131 477479 (42.2
4) (39.35, 45.13) 535 261 (48.8 262
(49.0 ) (44.57, 53.13) 1129 196197 (1
7.4) (15.23, 1
9.78) 555 103 (18.6) (15.4, 22.
0)
Mild 1131 187188 (16.5
6) (14.45, 18.89) 535 108107 (20.2
0) (16.97, 23.86) 1129 110111 (9.
78) (8.12, 11.
67) 555 62 (11.2) (8.7, 14.1
)
Moderate 1131 282 (24.9 283
(25.0 ) (22.45, 27.67) 535 139141 (26.0
4) (22.7, 30.3, 29.
9) 1129 84 (7.4) (6.0, 9.1) 555 40 (7.2) (5.2, 9.7)
Severe 1131 8 (0.7) (0.3, 1.4) 535 14 (2.6) (1.4, 4.4) 1129 2 (0.2) (0.0, 0.6) 555 1 (0.2) (0.0, 1.0)
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
New or
worsened joint
paindpaine
Any 1131 229 (20.2) (17.9, 22.7) 535 141142 (26.4
5) (22.78, 30.35) 1129 107 (9.5) (7.8, 11.3
) 555 42 (7.6) (5.5, 10.1
)
Mild 1131 122 (10.8) (9.0, 12.7) 535 6162 (11.46) (8.89.0, 14.46) 1129 63 (5.6) (4.3, 7.1) 555 26 (4.7) (3.1, 6.8)
Moderate 1131 102 (9.0) (7.4, 10.8) 535 73 (13.6) (10.9, 16.8) 1129 44 (3.9) (2.8, 5.2) 555 16 (2.9) (1.7, 4.6)
Severe 1131 5 (0.4) (0.1, 1.0) 535 7 (1.3) (0.5, 2.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
Grade 4 1131 0 (0.0, 0.3) 535 0 (0.0, 0.7) 1129 0 (0.0, 0.3) 555 0 (0.0, 0.7)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492669
Any systemic
eventgeventh 1131 1026 1027 (90
.78) (88.989.0, 92.3
4) 535 472473 (88.2
4) (85.2, 90.84, 9
1.0) 1129 726 (64.3) (61.4, 67.
1) 555 343 (61.8) (57.6, 65.
9)
Use of
antipyretic or
pain
medicationhmed
icationi 1131 664 (58.7) (55.8, 61.6) 535 279 (52.1) (47.8, 56.5) 1129 176 (15.6) (13.5, 17.
8) 555 95 (17.1) (14.1, 20.
5)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e -diary) from Day 1 through Day 7 after each dose. Grade 4
events were classified by the investigator or medically qualified person.
Note: Subject C4591001 1077 10771278 (13 years of age) experienced systemic events, including a temperature of 40.4°C, on the day of Dose 2. Since these
events were recorded as adverse events and not in the e -diary, they do not appear in this table.
a. N = number of subjects reporting at least 1 yes or no response for the specified event after the specified dose.
b. n = Number of subjects with the specified characteristic.
c. Exact 2 -sided CI based on the Clopper and Pearson method.
d.
d. Only subjects with "Pyrexia, Body temperature increased" dictionary terms and non- missing AE toxicity grade recorded in AE and missing e -diary related
fever measurements, are counted in this row.
e. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or
hospitalization for severe fatigue, severe headache, severe chills, severe muscle pain, or severe joint pain.
ef. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or hospitalization
for severe vomiting.
fg. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit
or hospitalization for severe diarrhea.
gh. Any systemic event: any fever ≥38.0°C , any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new
or worsened joint pain.
hi. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:2229APR2021 (21:11) Source Data: adfacevd Table Generation: 27MAR2021
(01:55 25JAN2022 (21:02)
(Cutoff Date: 13MAR2021, Snapshot D ate: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_s020_se_sev_ped_saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492670
Duration (Days) From First to Last Day of Systemic Events –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
1 Fever (≥38.0°C) Fevera
nanb 114 39 12 8
Mean (SD) 1.1 (0. 4548) 1.12 (0.5254) 1.7 (1.37) 1.9 (2.27)
Median 1.0 1.0 1.0 1.0
Min, max (1, 4) (1, 4) (1, 5) (1, 7)
UnknownbUnknownc 0 0 0 1
Fatigue
nanb 677678 318319 457 213
Mean (SD) 2.5 (3.20) 2.45 (2.0811) 3.1 (2.92) 3.0 (2. 6768)
Median 2.0 2.0 2.0 2.0
Min, max (1, 45) (1, 11) (1, 22) (1, 15)
UnknownbUnknownc 0 0 2 3
Headache
nanb 623624 286288 396 205
Mean (SD) 2.4 (2.27) 2.5 (2. 5150) 2.7 (2.55) 2.9 (3.17)
Median 1.0 1.0 1.0 1.0
Min, max (1, 24) (1, 25) (1, 21) (1, 22)
UnknownbUnknownc 0 0 1 2
Chills
nanb 311312 133134 109 47
Mean (SD) 1.6 (1.48) 1.5 (1.28) 2.6 (2.87) 2.3 (1.82)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492671
Duration (Days) From First to Last Day of Systemic Events –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Median 1.0 1.0 1.0 2.0
Min, max (1, 15) (1, 8) (1, 22) (1, 7)
UnknownbUnknownc 1 1 2 1
Vomiting
nanb 31 9 10 9
Mean (SD) 1.2 (0.88) 1.6 (1.33) 1.1 (0.32) 1.6 (1.13)
Median 1.0 1.0 1.0 1.0
Min, max (1, 5) (1, 5) (1, 2) (1, 4)
Diarrhea
nanb 90 57 8283 62
Mean (SD) 1.6 (1.25) 1.7 (1.62) 1.7 (1. 5251) 1.7 (1.42)
Median 1.0 1.0 1.0 1.0
Min, max (1, 7) (1, 9) (1, 8) (1, 7)
New or worsened muscle pain
nanb 272 143144 148 78
Mean (SD) 1.7 (1.28) 1.8 (1.65) 2.4 (3.02) 1.8 (1.95)
Median 1.0 1.0 1.0 1.0
Min, max (1, 9) (1, 10) (1, 22) (1, 13)
UnknownbUnknownc 0 1 0 1
New or worsened joint pain
nanb 109 70 77 28
Mean (SD) 1.6 (1.33) 1.7 (2.83) 2.2 (2.88) 2.7 (2.60)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492672
Duration (Days) From First to Last Day of Systemic Events –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Median 1.0 1.0 1.0 1.5
Min, max (1, 8) (1, 24) (1, 22) (1, 12)
Use of antipyretic or pain medication
nanb 413 167 111 62
Mean (SD) 1.6 (1.37) 1.7 (1.57) 2.1 (2.32) 3.2 (4.16)
Median 1.0 1.0 1.0 1.0
Min, max (1, 20) (1, 10) (1, 19) (1, 23)
UnknownbUnknownc 0 0 1 2
2 Fever (≥38.0°C) Fevera
nanb 215217 8488 7 2
Mean (SD) 1.1 (0 (0.37 .38) 1.1 (0. 2841) 3.0 (4.86) 1.0 (NE)
Median 1.0 1.0 1.0 1.0
Min, max (1, 6) (1, 23) (1, 14) (1, 1)
UnknownbUnknownc 1 0 0 1
Fatigue
nanb 726732 320323 264265 115116
Mean (SD) 2.1 (1.92) 2.3 (2 (2.44 .43) 2.8 (3. 0605) 3.32 (4.3837)
Median 1.0 1.0 2.0 2.0
Min, max (1, 23) (1, 28) (1, 37) (1, 38)
UnknownbUnknownc 4 3 2 4
Headache
nanb 708710 297300 263 118
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492673
Duration (Days) From First to Last Day of Systemic Events –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Mean (SD) 2.1 (2. 1615) 2.1 (2.42 (3.09 ) 2.5 (2.39) 3.5 (5.64)
Median 1.0 1.0 1.0 1.0
Min, max (1, 36) (1, 2442) (1, 23) (1, 35)
UnknownbUnknownc 6 1 3 3
Chills
nanb 455 195196 7374 22
Mean (SD) 1.5 (1.07) 1.3 (0. 9190) 2.1 (1. 9089) 2.0 (1.41)
Median 1.0 1.0 1.0 2.0
Min, max (1, 9) (1, 11) (1, 8) (1, 6)
UnknownbUnknownc 1 1 1 1
Vomiting
nanb 2930 13 12 9
Mean (SD) 1.0 (0. 1918) 1.2 (0.38) 1.4 (0.90) 1.6 (1.67)
Median 1.0 1.0 1.0 1.0
Min, max (1, 2) (1, 2) (1, 4) (1, 6)
Diarrhea
nanb 6567 39 43 2627
Mean (SD) 2.1 (4. 3831) 1.4 (0.94) 1.5 (1.04) 4.42 (7.7057)
Median 1.0 1.0 1.0 1.0
Min, max (1, 35) (1, 5) (1, 5) (1, 33)
UnknownbUnknownc 1 0 1 1
New or worsened muscle pain
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492674
Duration (Days) From First to Last Day of Systemic Events –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
nanb 355358 199201 9091 48
Mean (SD) 1.67 (1.49) 1.6 (1.82) 2.1 (1.84) 2.3 (2.04)
Median 1.0 1.0 1.0 1.0
Min, max (1, 17) (1, 23) (1, 9) (1, 9)
UnknownbUnknownc 1 1 0 0
New or worsened joint pain
nanb 173 107108 51 20
Mean (SD) 1.5 (1.26) 1.6 (2. 7574) 2.7 (2.61) 2.2 (1.81)
Median 1.0 1.0 1.0 1.0
Min, max (1, 8) (1, 28) (1, 12) (1, 8)
UnknownbUnknownc 2 2 0 0
Use of antipyretic or pain medication
nanb 557 223 95 59
Mean (SD) 1.6 (1.37) 1.8 (2.64) 1.9 (2.61) 2.1 (2.28)
Median 1.0 1.0 1.0 1.0
Min, max (1, 12) (1, 28) (1, 23) (1, 15)
UnknownbUnknownc 3 0 2 2
Abbreviation: NE = not estimable.
Note: Duration was calculated in days as the difference from the start of the first reported event to the resolution of the l ast reported event, inclusive. For
symptoms that are ongoing at the time of the next dose, stop date is computed as the next dose d ate.
Note: Events and use of antipyretic or pain medication were recorded in the electronic diary (e -diary) from Day 1 through Day 7 after each dose. The resolution
date for events lasting longer than 7 days was recorded on the subject's case report form.
Note: Subject C4591001 1077 10771278 (13 years of age) experienced systemic events, including a temperature of 40.4°C, on the day of Dose 2. Since these
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492675
Duration (Days) From First to Last Day of Systemic Events –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
events were recorded as adverse events and not in the e -diary, they do not appear in this table.
a.a. Includes subjects with "Pyrexia, Body temperature increased" dictionary terms and non- missing AE toxicity grade recorded in AE, and subjects with
temperature recorded in e -diary.
b. n = Number of subjects reporting the specified event on any of the 7 days, including subjects with events of unknown duration.
bc. Includes those events where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:1929APR2021 (21:06) Source Data: adcevd Table Generation: 2 7MAR2021 (02:57 25JAN2022
(21:29 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_s040_se_dur_ped_saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492676
Onset Days for Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
1 Fever (≥38.0°C) Fevera
nanb 114 39 12 8
Mean (SD) 2.1 (0.37) 2.4 (1.29) 3.6 (2.02) 3.0 (2.00)
Median 2.0 2.0 3.0 2.5
Min, max (1, 5) (1, 7) (1, 7) (1, 7)
Fatigue
nanb 677678 318319 457 213
Mean (SD) 1.8 (0.99) 1.9 (1.15) 2.0 (1.49) 2.3 (1.63)
Median 2.0 2.0 1.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Headache
nanb 623624 286288 396 205
Mean (SD) 2.1 (1.21) 2.2 (1.37) 2.4 (1.69) 2.4 (1.58)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Chills
nanb 311312 133134 109 47
Mean (SD) 2.1 (1.00) 2.2 (1.19) 2.9 (1.75) 2.9 (1.91)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Vomiting
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492677
Onset Days for Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
nanb 31 9 10 9
Mean (SD) 3.0 (1.67) 3.4 (2.13) 3.0 (1.83) 3.2 (1.48)
Median 2.0 2.0 2.0 3.0
Min, max (1, 7) (1, 7) (1, 6) (1, 5)
Diarrhea
nanb 90 57 8283 62
Mean (SD) 3.7 (1.79) 3.2 (1.48) 3.6 (1. 8586) 3.5 (1.81)
Median 3.0 3.0 3.0 3.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
New or worsened muscle pain
nanb 272 143144 148 78
Mean (SD) 2.1 (1.08) 2.2 (1.11) 2.5 (1.68) 3.0 (1.69)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
New or worsened joint pain
nanb 109 70 77 28
Mean (SD) 2.5 (1.41) 2.5 (1.32) 3.0 (1.92) 3.4 (1.79)
Median 2.0 2.0 2.0 3.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Any systemic eventbeventc
nanb 877878 403405 636637 311
Mean (SD) 1.8 (1.01) 1.8 (1.06) 2.0 (1.9 (1.38 39) 2.1 (1.40)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492678
Onset Days for Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Median 2.0 2.0 1.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Use of antipyretic or pain medication
nanb 413 167 111 62
Mean (SD) 2.1 (0.91) 2.2 (1.03) 3.3 (1.93) 3.5 (1.90)
Median 2.0 2.0 3.0 3.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
2 Fever (≥38.0°C) Fevera
nanb 215217 8488 7 2
Mean (SD) 2.0 (0.31) 2.0 (0. 5457) 3.0 (2.45) 1.5 (0.71)
Median 2.0 2.0 2.0 1.5
Min, max (1, 4) (1, 6) (1, 7) (1, 2)
Fatigue
nanb 726732 320323 264265 115116
Mean (SD) 1.8 (0.67) 1.8 (0.79) 2.1 (1.59) 2.43 (1.48)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Headache
nanb 708710 297300 263 118
Mean (SD) 1.9 (0.66) 2.0 (0. 9291) 2.5 (1.68) 2.7 (1.83)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492679
Onset Days for Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Chills
nanb 455 195196 7374 22
Mean (SD) 2.0 (0.80) 1.9 (0.53) 2.8 (1.96) 3.0 (1.73)
Median 2.0 2.0 2.0 3.0
Min, max (1, 7) (1, 4) (1, 7) (1, 7)
Vomiting
nanb 2930 13 12 9
Mean (SD) 2.43 (1.12) 2.3 (0.85) 4.1 (1.62) 3.4 (2.35)
Median 2.0 2.0 4.0 3.0
Min, max (1, 7) (2, 5) (2, 7) (1, 7)
Diarrhea
nanb 6567 39 43 2627
Mean (SD) 3.0 (1 (1.55 .57) 3.0 (1.48) 3.7 (2.06) 3.8 (1.97 9 (2.03 )
Median 3.0 3.0 4.0 3.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
New or worsened muscle pain
nanb 355358 199201 9091 48
Mean (SD) 2.1 (0.83) 2.0 (0.72) 2.78 (1.9094) 2.8 (1.66)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
New or worsened joint pain
nanb 173 107108 51 20
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492680
Onset Days for Systemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) –
Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
Dose Systemic Event 12-15 Years 16-25 Years 12-15 Years 16-25 Years
Mean (SD) 2.1 (0.77) 2.0 (0.68) 2.9 (1.81) 3.8 (2.07)
Median 2.0 2.0 2.0 4.0
Min, max (1, 6) (1, 7) (1, 7) (1, 7)
Any systemic eventbeventc
nanb 904910 396400 439441 183184
Mean (SD) 1.8 (0.77) 1.8 (0. 8887) 2.3 (1. 7071) 2.32 (1.4647)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Use of antipyretic or pain medication
nanb 557 223 95 59
Mean (SD) 2.0 (0.69) 2.0 (0.93) 3.2 (2.04) 3.0 (1.49)
Median 2.0 2.0 3.0 3.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Note: Day of onset is the first day the specified event was reported.
Note: Subject C4591001 1077 10771278 (13 years of age) experienced systemic events, including a. Includes subjects with "Pyrexia, Body temperature of
40.4°C, on the day of Dose 2. Since these events were increased" dictionary terms and non-missing AE toxicity grade recorded as adverse events and not in the
electronic diary ( AE, and subjects with temperature recorded in e- diary ), they do not appear in this table.
a.
b. n = Number of subjects reporting the specified event, with each subject counted only once per event.
bc. Any systemic event: any fever ≥38.0°C , any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new
or worsened joint pain.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:2229APR2021 (21:11) Source Data: adfacevd Table Generation: 27MAR202126JAN2022
(01:5521)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_s060_se_onset_ped_saf
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492681
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
12-15 C4591001 1009
10091288 1 04DEC2020 Pain at the
injection site Mild Sev Mild N N N N 06DEC2020 3
C4591001 1009
10091396 2 26JAN2021 Pain at the
injection site Mild Sev Mild N N N N 28JAN2021 3
C4591001 1013
10131845 1 03DEC2020 Pain at the
injection site Sev Mod N 04DEC2020 2
C4591001 1057
10571438 1 04JAN2021 Pain at the
injection site N Sev Mild Mild N N N 07JAN2021 3
C4591001 1066
10661408 1 08DEC2020 Pain at the
injection site Mod Sev Mild Mild N N N 11DEC2020 4
C4591001 1091
10911406 2 28DEC2020 Pain at the
injection site Sev Mod Mild N N N N 30DEC2020 3
C4591001 1091
10911428 1 16DEC2020 Pain at the
injection site Mod Sev Mild Mild N N 19DEC2020 4
C4591001 1140
11401359 1 23DEC2020 Pain at the
injection site N Sev N N N N N 24DEC2020 1
C4591001 1140
11401376 1 29DEC2020 Pain at the
injection site Mild Sev Mild Mild N N N 01JAN2021 4
2 20JAN2021 Pain at the
injection site Mild Sev Mod Mild N N N 23JAN2021 4
C4591001 1142
11421340 2 28DEC2020 Pain at the
injection site Mod Sev Mild N N N N 30DEC2020 3
C4591001 1142
11421369 2 15JAN2021 Pain at the
injection site Mod Sev N N N N N 16JAN2021 2
C4591001 1147
11471320 2 27JAN2021 Pain at the
injection site Mod Sev Mod Mild Mild 06FEB2021 11
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492682
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1150
11501124 2 10NOV2020 Pain at the
injection site Mod Sev Mod Mild N N 13NOV2020 4
C4591001 1150
11501250 1 29DEC2020 Pain at the
injection site Mod Sev Mild N N N N 31DEC2020 3
C4591001 1152
11521697 1 18DEC2020 Pain at the
injection site Mod Sev Mild Mild N N N 21DEC2020 4
C4591001 1156
11561249 1 16OCT2020 Redness (cu) 21 17OCT2020 1
Redness (svt) N Sev N N N N
C4591001 1156
11561310 1 01DEC2020 Pain at the
injection site N Sev Mild Mild N 04DEC2020 3
C4591001 1235
12351253 1 08JAN2021 Pain at the
injection site Mild Sev Mild N N N N 10JAN2021 3
16-25 C4591001 1008
10081782 2 30DEC2020 Redness (cu) 21 21 02JAN2021 2
Redness (svt) N N Sev Sev N N
C4591001 1057
10571368 1 23NOV2020 Pain at the
injection site Mild Sev N N N N N 24NOV2020 2
C4591001 1090
10901043 2 24AUG2020 Pain at the
injection site Sev Sev Mild N N Mild 01NOV2020 70
C4591001 1120
11201130 2 03SEP2020 Pain at the
injection site Sev Mod Mild Mild Mild N 07SEP2020 5
C4591001 1125
11251243 1 08DEC2020 Pain at the
injection site Mild Sev Sev Mild N N 11DEC2020 4
C4591001 1142
11421316 1 24NOV2020 Pain at the
injection site Mild Sev N N N N N 25NOV2020 2
C4591001 1150
11501152 2 23DEC2020 Pain at the
injection site Sev Mod Mild N 25DEC2020 3
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492683
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1162
11621019 1 03AUG2020 Pain at the
injection site N Sev N N N N 04AUG2020 1
C4591001 1194
11941069 1 20OCT2020 Pain at the
injection site Sev Mod Mild N N N N 22OCT2020 3
C4591001 1194
11941091 1 22OCT2020 Pain at the
injection site Mod Sev Mild Mild Mild N 26OCT2020 5
C4591001 1205
12051079 1 11NOV2020 Pain at the
injection site Sev Mod Mild N N N N 13NOV2020 3
2 02DEC2020 Pain at the
injection site Mod Sev Mod Mild Mild Mild Mild 09DEC2020 8
C4591001 1212
12121007 2 17NOV2020 Pain at the
injection site Mod Sev Mild Mild N N N 20NOV2020 4
C4591001 1217
12171012 1 23OCT2020 Pain at the
injection site Mild Sev Mild N N N N 25OCT2020 3
C4591001 1226
12261096 1 11AUG2020 Pain at the
injection site Mild Sev Mild N N Mild N 16AUG2020 6
C4591001 1230
12301018 1 24SEP2020 Pain at the
injection site Sev Sev Mild N N N N 26SEP2020 3
C4591001 1230
12301133 1 05OCT2020 Redness (cu) 2 21 07OCT2020 1
Redness (svt) N Sev N N N N
C4591001 1231
12311018 2 27AUG2020 Pain at the
injection site N Sev Mild Mild Mild N N 31AUG2020 4
C4591001 1231
12311055 1 11AUG2020 Pain at the
injection site Mild Sev Mod Mild Mild Mild Mild 17AUG2020 7
C4591001 1231
12311162 1 13AUG2020 Pain at the
injection site Mild Sev Mild N N N N 15AUG2020 3
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492684
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1247
12471033 2 15OCT2020 Pain at the
injection site N Sev Sev N N 19OCT2020 2
C4591001 1247
12471199 1 06OCT2020 Redness (cu) 21 21 07OCT2020 2
Redness (svt) Sev Sev N N
Swelling (cu) 21 06OCT2020 1
Swelling (svt) Sev N N N
Abbreviations: cu = caliper units; Dur = duration; Mod = moderate; N = none; Sev = severe; svt = severity.
a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1.
b. The maximum measurable size for redness and swelling in the electronic diary (e -diary) was 21 caliper units. Redness and swelling exceeding 21 caliper
units are reported as >21. Study sites recorded i njection site redness or swelling in centimeters. These were converted to caliper units (1 caliper unit = 0.5
centimeters).
c. Stop date is the date the reaction was last reported.
d. Duration (days) was calculated as the difference from the start of the first reported reaction to resolution of the last reported reaction, inclusive. If the
reaction continued beyond Day 7, the calculation includes all days from the last e -diary day until the date of resolution collected on the case report form. If the
reaction was ongoing at the time of the subsequent vaccination, the end date/day for the reaction is the date/day that the ne xt vaccine was administered, which
was used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22 29APR2021 (21:11) Source Data: adfacevd Table Generation: 27MAR202126JAN2022
(01:5552)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_l004_sevlr_ped
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492685
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
12-15 C4591001
1005
10051317 2 12NOV2020 Oral
temperature
(°C) 36.7 39.1 37.5 37.1 36.6 36.8 36.6 13NOV2020 1
C4591001
1005
10051328 2 11NOV2020 Headache N Sev N N N N N 12NOV2020 1
C4591001
1006
10061189 1 01DEC2020 Oral
temperature
(°C) 37.1 39.9 36.8 36.9 35.8 37.1 37.4 02DEC2020 1
2 22DEC2020 Oral
temperature
(°C) 37.3 39.3 37.3 37.1 36.9 23DEC2020 1
C4591001
1006
10061220 2 28DEC2020 Headache N Sev Mild N N N 30DEC2020 2
C4591001
1006
10061297 1 29DEC2020 Oral
temperature
(°C) 36.7 39.4 37.1 37.1 36.8 37.1 36.8 30DEC2020 1
Fatigue N Sev N N N N N 30DEC2020 1
C4591001
1007
10071544 2 30DEC2020 Fatigue N Sev N N N N N 31DEC2020 1
C4591001
1007
10071546 2 30DEC2020 Chills Sev N N N N N N 30DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492686
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1007
10071620 2 20JAN2021 Fatigue N Sev Mod Mod Mod Mod Mod
Headache N Sev Mod Sev Mild Mod Mod
Chills N Sev N Mod N N Mod 27JAN2021 7
New or
worsened
muscle pain N Sev Mod Sev Mod Mod Mod
New or
worsened
joint pain N Sev Mod Sev Mod Mod Mod
C4591001
1007
10071626 2 20JAN2021 Oral
temperature
(°C) 36.8 39.1 36.7 36.6 36.7 36.9 21JAN2021 1
C4591001
1007
10071639 2 25JAN2021 Fatigue Mild Sev Mild N N N N 27JAN2021 3
C4591001
1007
10071642 1 04JAN2021 Fatigue N Sev N N N Mild Mild 01FEB2021 28
C4591001
1007
10071659 2 27JAN2021 Fatigue N Sev Mild N N N N 29JAN2021 2
C4591001
1008
10081802 1 17DEC2020 Oral
temperature
(°C) 36.6 39.1 36.3 36.4 35.7 36.9 35.8 18DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492687
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1008
10081809 1 18DEC2020 Headache Sev N N N 18DEC2020 1
C4591001
1008
10081827 1 21DEC2020 Fatigue N Sev N N N N N 22DEC2020 1
Headache N Sev N N N N N 22DEC2020 1
C4591001
1008
10081846 2 11JAN2021 Oral
temperature
(°C) 37.3 39.3 36.4 36.2 36.1 36.2 12JAN2021 1
C4591001
1008
10081908 2 27JAN2021 Oral
temperature
(°C) 36.8 39.7 37.3 37.1 36.9 37 37.1 28JAN2021 1
C4591001
1009
10091220 1 19OCT2020 Fatigue Mod Sev N Mod N 24OCT2020 6
C4591001
1009
10091221 1 19OCT2020 New or
worsened
joint pain Sev N N N 19OCT2020 1
C4591001
1009
10091288 2 23DEC2020 Chills N Sev N N N N N 24DEC2020 1
C4591001
1009
10091310 2 29DEC2020 Headache Mild Sev N N N 30DEC2020 2
C4591001
1009
10091317 1 10DEC2020 Oral
temperature
(°C) 37.3 39 36.6 37.4 36.9 36.8 36.9 11DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492688
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
Headache N Sev N N N N N 11DEC2020 1
C4591001
1009
10091318 2 29DEC2020 Oral
temperature
(°C) 36.6 39 37.1 37 36.6 36.3 36.9 30DEC2020 1
C4591001
1009
10091321 2 30DEC2020 Fatigue N Sev Mild N N N N 01JAN2021 2
Chills N Sev N N N N N 31DEC2020 1
C4591001
1009
10091326 1 11DEC2020 Headache N Sev N N N N N 12DEC2020 1
C4591001
1009
10091328 2 30DEC2020 Headache N Sev N Mild N N N 02JAN2021 3
C4591001
1009
10091355 2 08JAN2021 Headache Sev N N N N 09JAN2021 1
C4591001
1009
10091358 1 17DEC2020 Headache N N N N N N Sev 23DEC2020 1
C4591001
1009
10091361 1 17DEC2020 Fatigue Mod Mod Sev Mild N N N 20DEC2020 4
Headache Mild Sev Mod Mild Mild Mild N 22DEC2020 6
C4591001
1009
10091362 1 17DEC2020 Chills Sev Mod N N Mod Mild 24DEC2020 8
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492689
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1013
10131841 1 02DEC2020 Fatigue Sev N 03DEC2020 1
Headache Sev N 03DEC2020 1
C4591001
1013
10131859 1 09DEC2020 Fatigue N Sev N N N N N 10DEC2020 1
Headache N Sev N N N N N 10DEC2020 1
C4591001
1013
10131866 2 06JAN2021 Fatigue N Sev N N N N 07JAN2021 1
Chills N Sev N N N N 07JAN2021 1
C4591001
1013
10131871 1 21DEC2020 Oral
temperature
(°C) 36.8 39 36.7 36.7 38.9 37.2 25DEC2020 4
Fatigue Mild Sev N N N N 22DEC2020 2
C4591001
1016
10161307 1 15OCT2020 Fatigue Mod Sev Mild Mod Mild N Mild 22OCT2020 8
C4591001
1016
10161326 2 10NOV2020 New or
worsened
joint pain N Sev N N N N 11NOV2020 1
C4591001
1016
10161330 1 20OCT2020 Headache N N N N N N Sev 27OCT2020 2
C4591001
1016
10161373 2 27JAN2021 Headache N Sev N N N N N 28JAN2021 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492690
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
Chills N Sev N N N Mild N 01FEB2021 5
C4591001
1039
10391304 2 19JAN2021 Fatigue N Sev N N N N N 20JAN2021 1
C4591001
1039
10391318 2 29JAN2021 Fatigue Mod Sev Mild Mild Mild 04FEB2021 7
C4591001
1044
10441266 1 08DEC2020 Fatigue Mod Sev N Mild N N N 11DEC2020 4
2 28DEC2020 Chills Sev N N N N N 29DEC2020 1
C4591001
1044
10441291 2 06JAN2021 Oral
temperature
(°C) 36.1 39.6 37.2 36.1 36.9 36.4 36.6 07JAN2021 1
C4591001
1044
10441300 2 18JAN2021 Fatigue Sev N N N N 19JAN2021 1
C4591001
1044
10441316 1 04JAN2021 Chills N Sev N N N N N 05JAN2021 1
C4591001
1044
10441322 2 27JAN2021 Headache N Sev N N N N N 28JAN2021 1
C4591001
1044
10441331 2 27JAN2021 Fatigue N Sev N N N N N 28JAN2021 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492691
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1044
10441343 2 29JAN2021 Oral
temperature
(°C) 37.3 39.5 37.7 37.5 36.2 36.6 36.5 30JAN2021 1
Fatigue Mod Sev Mod Mod Mod Mod Mod
Chills N Sev Mod N N N N 31JAN2021 2
C4591001
1044
10441355 2 29JAN2021 Headache N Sev Mild Mild N Mild N 03FEB2021 5
C4591001
1044
10441379 2 04FEB2021 Fatigue Mild Sev N N N N N 05FEB2021 2
C4591001
1057
10571382 1 08DEC2020 Oral
temperature
(°C) 35.9 39.1 36.9 36.8 37.4 37.1 36.5 09DEC2020 1
Fatigue N Sev N N N N N 09DEC2020 1
C4591001
1057
10571411 2 06JAN2021 Fatigue N Sev Mod Mild N N N 09JAN2021 3
C4591001
1057
10571424 1 24DEC2020 Chills N Mod Sev Mod Mod Mild 01JAN2021 8
C4591001
1057
10571428 1 24DEC2020 Fatigue N N N N Sev Sev 31DEC2020 3
Headache N N N N Mod Sev 31DEC2020 3
Chills N N N Mod Sev N 29DEC2020 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492692
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1057
10571438 2 25JAN2021 Oral
temperature
(°C) 36.8 39.2 36.6 36.7 36.9 37.1 26JAN2021 1
C4591001
1057
10571451 1 12JAN2021 Oral
temperature
(°C) 36.5 39.2 38.1 37.1 37.3 36.3 36.6 14JAN2021 2
C4591001
1066
10661408 2 28DEC2020 Headache Mild Sev Mild N N 30DEC2020 3
C4591001
1077
10771280 2 04JAN2021 Fatigue Sev Sev N N N 05JAN2021 2
New or
worsened
muscle pain Sev Sev Mild N N 06JAN2021 3
C4591001
1084
10841546 1 18DEC2020 Fatigue Mild Sev Mild Mild N N N 21DEC2020 4
Headache Mild Sev Mild Mild N N Mild 24DEC2020 7
C4591001
1084
10841571 1 30DEC2020 Fatigue Mild Mild Sev 05JAN2021 6
C4591001
1084
10841580 1 06JAN2021 Oral
temperature
(°C) 37.5 39.9 37.7 36.4 36.8 36.8 37 07JAN2021 1
C4591001
1084
10841593 2 29JAN2021 Headache N Sev Mild N N N 31JAN2021 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492693
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1091
10911457 1 29DEC2020 Fatigue Sev Mod Mod Sev Mod N Mod 05JAN2021 8
2 18JAN2021 Fatigue Sev Mod Mod Mild N N 22JAN2021 4
Headache Sev Mod Mild N N N 21JAN2021 3
C4591001
1123
11231440 2 28DEC2020 Headache N Sev N N N N 29DEC2020 1
C4591001
1123
11231442 1 09DEC2020 Oral
temperature
(°C) 39.7 33.4 33.4 34.6 34.1 34.1 09DEC2020 1
C4591001
1123
11231461 2 05JAN2021 Oral
temperature
(°C) 37.8 39.3 37.6 37.1 36.4 36.7 06JAN2021 1
C4591001
1123
11231475 2 11JAN2021 Oral
temperature
(°C) 36.8 39.4 36.8 36.8 37.5 37.1 12JAN2021 1
C4591001
1123
11231481 2 12JAN2021 Headache N Sev Mild N N N 14JAN2021 2
C4591001
1123
11231484 2 12JAN2021 Oral
temperature
(°C) 39.4 37.5 37.1 36.6 36.3 13JAN2021 1
Headache Sev Mild Mod Mod N 16JAN2021 4
C4591001
1123
11231495 2 13JAN2021 Fatigue Mod Sev N N N N 14JAN2021 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492694
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1123
11231513 1 30DEC2020 Headache N N N N Sev Mild N 04JAN2021 2
C4591001
1124
11241251 2 08JAN2021 Oral
temperature
(°C) 37.6 39 36.9 36.7 36.7 09JAN2021 1
C4591001
1125
11251248 1 11DEC2020 Fatigue Mod Sev Mod Mod Mild Mild Mild 17DEC2020 7
C4591001
1125
11251252 1 16DEC2020 Fatigue Sev N 17DEC2020 1
C4591001
1126
11261263 1 04DEC2020 Chills N Sev N N N N 05DEC2020 1
C4591001
1126
11261273 2 06JAN2021 Headache N Sev Mild Mild N N N 09JAN2021 3
C4591001
1126
11261281 1 16DEC2020 Headache N Mild Sev N N N N 18DEC2020 2
C4591001
1126
11261286 1 16DEC2020 Oral
temperature
(°C) 37.2 39 36.8 36.9 36.6 36.8 36.4 17DEC2020 1
C4591001
1126
11261299 2 12JAN2021 New or
worsened
muscle pain N N Sev N N N N 14JAN2021 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492695
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1126
11261307 1 04JAN2021 Chills N Sev N N N N N 05JAN2021 1
C4591001
1126
11261309 1 04JAN2021 New or
worsened
muscle pain N Sev N N N N 05JAN2021 1
2 25JAN2021 Fatigue Mild Sev N N N N N 26JAN2021 2
Chills Mild Sev N N N N N 26JAN2021 2
C4591001
1126
11261310 2 26JAN2021 Headache N Sev N N N N 27JAN2021 1
C4591001
1126
11261315 1 06JAN2021 Oral
temperature
(°C) 36.9 39.3 36.3 36.8 36.6 36.9 36.8 07JAN2021 1
C4591001
1126
11261324 2 28JAN2021 Oral
temperature
(°C) 36.4 39.2 36.6 36.2 36.5 36.3 35.8 29JAN2021 1
C4591001
1131
11311290 2 20JAN2021 Fatigue Mod Sev N N N N 21JAN2021 2
Headache N Sev N N N N 21JAN2021 1
C4591001
1131
11311302 2 01FEB2021 Oral
temperature
(°C) 36.2 39.6 36.5 36.4 36.3 36.3 02FEB2021 1
C4591001
1139
11391155 2 28DEC2020 Fatigue N Sev Mild N N N N 30DEC2020 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492696
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1139
11391238 1 07JAN2021 Headache Mild Sev Mod Mild Mild N Mild 14JAN2021 8
C4591001
1140
11401328 2 05JAN2021 Oral
temperature
(°C) 36.7 39.5 37.1 37 37.1 37 37 06JAN2021 1
C4591001
1140
11401329 2 05JAN2021 Oral
temperature
(°C) 36.8 40 36.9 36.5 36.6 36.7 36.7 06JAN2021 1
C4591001
1140
11401343 1 21DEC2020 Headache N N Sev N N N N 23DEC2020 1
Vomiting N N Sev N N N N 23DEC2020 1
C4591001
1140
11401345 2 11JAN2021 Oral
temperature
(°C) 36.2 38.9 36.4 35.7 36.8 12JAN2021 1
C4591001
1140
11401352 2 13JAN2021 Headache Mild Sev N N N N Mild 17FEB2021 36
C4591001
1140
11401359 1 23DEC2020 Fatigue N Sev N N N N N 24DEC2020 1
C4591001
1140
11401378 2 20JAN2021 Fatigue Mod Sev N N N 21JAN2021 2
C4591001
1140
11401380 2 19JAN2021 Chills Sev N N N N N 20JAN2021 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492697
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1140
11401391 2 28JAN2021 Headache Sev N Mod N N 01FEB2021 3
C4591001
1140
11401400 1 08JAN2021 Headache N N N Mod N Sev 20JAN2021 9
C4591001
1142
11421340 1 07DEC2020 Fatigue N Sev N N N N N 08DEC2020 1
Headache N Sev N N N N N 08DEC2020 1
2 28DEC2020 Headache Mod Sev N N N N N 29DEC2020 2
C4591001
1142
11421369 2 15JAN2021 Fatigue Mod Sev Mild N N N N 17JAN2021 3
Chills Mild Sev Mild N N N N 17JAN2021 3
New or
worsened
muscle pain N Sev N N N N N 16JAN2021 1
New or
worsened
joint pain N Sev N N N N N 16JAN2021 1
C4591001
1142
11421375 1 22DEC2020 Fatigue Sev N N N N N 22DEC2020 1
C4591001
1142
11421392 2 29JAN2021 Chills Sev N N N N N 30JAN2021 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492698
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1147
11471277 2 28DEC2020 New or
worsened
muscle pain N N N N Sev Sev 07JAN2021 6
C4591001
1147
11471285 2 04JAN2021 Fatigue Sev N 09JAN2021 1
C4591001
1147
11471301 1 19DEC2020 Fatigue N Sev Mild N N N 21DEC2020 2
C4591001
1147
11471312 2 09JAN2021 Fatigue Mild N N N N Sev N 14JAN2021 6
C4591001
1147
11471327 1 05JAN2021 Oral
temperature
(°C) 35.6 40.4 38 35.8 35.9 36.4 07JAN2021 08JAN2021 23
C4591001
1147
11471334 2 27JAN2021 Chills Sev Mild N N N N N 28JAN2021 2
C4591001
1147
11471337 2 27JAN2021 Chills N Sev N N N N N 28JAN2021 1
New or
worsened
muscle pain N Sev N N N N N 28JAN2021 1
C4591001
1147
11471347 2 28JAN2021 Chills N Sev Mild N N N 30JAN2021 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492699
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1150
11501198 2 30DEC2020 Fatigue N Sev 31DEC2020 1
C4591001
1150
11501245 1 28DEC2020 Headache N Sev N N N N 29DEC2020 1
2 19JAN2021 Headache N Sev N N N N N 20JAN2021 1
C4591001
1150
11501260 2 20JAN2021 Oral
temperature
(°C) 37.2 39.1 37.2 36.7 37.1 37 36.4 21JAN2021 1
C4591001
1150
11501274 2 25JAN2021 New or
worsened
muscle pain Sev N 26JAN2021 1
New or
worsened
joint pain Sev N 26JAN2021 1
C4591001
1150
11501297 1 11JAN2021 Oral
temperature
(°C) 37.2 39.1 37.4 37.1 36.9 36.9 37.1 12JAN2021 1
2 02FEB2021 Oral
temperature
(°C) 36.8 39.7 38.4 36.8 37.1 04FEB2021 2
Fatigue N Sev Mod N N 04FEB2021 2
Chills N Sev N N N 03FEB2021 1
C4591001
1150
11501299 1 12JAN2021 Chills N Sev Mild N N N N 14JAN2021 2
2 01FEB2021 Chills N Sev Mild N N N 03FEB2021 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492700
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1152
11521619 2 22DEC2020 Oral
temperature
(°C) 36.7 39.3 37.9 37.2 36.9 37 36.8 23DEC2020 1
C4591001
1152
11521670 2 30DEC2020 Chills N Sev N N N N N 31DEC2020 1
C4591001
1152
11521706 1 21DEC2020 Fatigue Mod Sev* Mod Sev* Mild Sev* NSev* Sev* Sev Mild Sev* 27DEC2020 7
Headache N N N N Sev Mod Sev* 27DEC2020 2
C4591001
1156
11561340 2 19JAN2021 Fatigue Sev Mod N N N 20JAN2021 2
C4591001
1156
11561342 2 19JAN2021 Oral
temperature
(°C) 36.8 39.9 37.1 37 37 37 37 20JAN2021 1
C4591001
1156
11561349 2 26JAN2021 Chills N Sev N N N N N 27JAN2021 1
C4591001
1156
11561356 1 07JAN2021 Fatigue Mild Sev Mod Mild N N N 10JAN2021 4
New or
worsened
muscle pain N Sev N N N N N 08JAN2021 1
C4591001
1156
11561358 2 29JAN2021 Fatigue N Sev Mild N N N N 31JAN2021 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492701
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1223
12231280 2 28JAN2021 Oral
temperature
(°C) 39.2 38.4 30JAN2021 2
C4591001
1235
12351236 2 22DEC2020 New or
worsened
muscle pain Mod Sev N N N N 23DEC2020 2
C4591001
1235
12351249 1 15DEC2020 Headache Sev Mod Mod Sev Mod Mild 04JAN2021 21
2 04JAN2021 Headache Sev Sev Sev Sev Sev 09JAN2021 6
C4591001
1235
12351254 2 28JAN2021 Fatigue Sev Mild N N N N 30JAN2021 2
Chills Sev N N N N N 29JAN2021 1
C4591001
1270
12701191 2 23DEC2020 Fatigue N Sev Mild N N N N 25DEC2020 2
C4591001
1270
12701207 2 05JAN2021 Oral
temperature
(°C) 37.4 39.5 37.4 37.1 37.2 36.8 37.4 06JAN2021 1
Fatigue N Sev Mod Mod N Mod N 10JAN2021 5
C4591001
1270
12701220 2 08JAN2021 Oral
temperature
(°C) 37.2 39.1 37.4 37.1 36.2 36.4 09JAN2021 1
C4591001
1270
12701239 2 28JAN2021 Oral
temperature
(°C) 36.2 39 36.1 36.1 36.3 36.1 36.2 29JAN2021 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492702
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
16-25 C4591001
1001
10011125 1 04AUG2020 Fatigue Mod Mod Sev Mild N 07AUG2020 4
Headache Mod Mod Sev Mod N 07AUG2020 4
New or
worsened
muscle pain N N Sev NSev* N 06AUG2020 07AUG2020 12
New or
worsened
joint pain N Mild Sev N N 06AUG2020 2
C4591001
1005
10051024 2 31AUG2020 Fatigue Sev N N N N 01SEP2020 1
C4591001
1005
10051434 2 12JAN2021 Chills N Sev N N N 13JAN2021 1
C4591001
1005
10051442 1 22DEC2020 Fatigue N Sev Mild Mild N Mild N 27DEC2020 5
C4591001
1006
10061185 2 21DEC2020 Chills N Sev N N N N N 22DEC2020 1
C4591001
1006
10061192 2 22DEC2020 Headache N Sev N Mild N N N 25DEC2020 3
C4591001
1006
10061210 2 23DEC2020 Headache N Sev N N N N N 24DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492703
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1006
10061246 1 10DEC2020 Fatigue N N Sev N N N N 12DEC2020 1
C4591001
1007
10071487 1 01DEC2020 Headache N Sev Mild N N 03DEC2020 2
C4591001
1007
10071503 1 03DEC2020 New or
worsened
muscle pain Sev Mod N N 04DEC2020 2
C4591001
1009
10091028 2 31AUG2020 New or
worsened
muscle pain N Sev N N N N N 01SEP2020 1
C4591001
1013
10131005 1 28JUL2020 Headache N N N N Sev N 01AUG2020 1
C4591001
1013
10131059 2 25AUG2020 Fatigue N Sev Mild N N N N 27AUG2020 2
C4591001
1015
10151035 2 04SEP2020 Fatigue Sev N N N N N 05SEP2020 1
New or
worsened
muscle pain Sev N N N N N 05SEP2020 1
New or
worsened
joint pain Sev N N N N N 05SEP2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492704
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1016
10161349 2 25NOV2020 Headache Mod Sev Mild N N N N 27NOV2020 3
C4591001
1044
10441244 2 14DEC2020 Fatigue N Sev Mild Mild Mild Mild N 19DEC2020 5
New or
worsened
muscle pain N Sev Mild N N N N 16DEC2020 2
C4591001
1044
10441245 2 14DEC2020 Fatigue Sev Mild N N N 16DEC2020 2
C4591001
1044
10441287 1 11DEC2020 Fatigue Mod Sev Mild Mild N Mild Mild
C4591001
1071
10711039 2 04SEP2020 Headache N N Mod Sev Mild Mild 21SEP2020 16
C4591001
1073
10731064 2 01SEP2020 Fatigue Mod Mod Mod Sev N N N 04SEP2020 4
Headache N Mod N Sev N N N 04SEP2020 3
C4591001
1073
10731083 2 02SEP2020 Fatigue Mod Sev N N N N 03SEP2020 2
Chills N Sev N N N N 03SEP2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492705
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1080
10801009 2 03SEP2020 Headache Sev Mod N N 05SEP2020 2
C4591001
1082
10821036 1 04AUG2020 Headache Mod N Mild N N N Sev 11AUG2020 8
2 25AUG2020 Headache N Sev Sev N N N Mod 31AUG2020 6
C4591001
1090
10901043 2 24AUG2020 Headache Mild Sev N N N Mild 30AUG2020 7
Chills N Sev N N N N 25AUG2020 1
C4591001
1107
11071010 2 18AUG2020 Headache Mod N Mod Sev Mod 23AUG2020 6
C4591001
1107
11071055 2 27AUG2020 Headache N Sev N N N N N 28AUG2020 1
C4591001
1109
11091020 2 18AUG2020 Headache Mod Sev N N N N 19AUG2020 2
C4591001
1112
11121045 1 03AUG2020 Oral
temperature
(°C) 36.9 39 37 37.1 36.9 36.8 36.6 04AUG2020 1
C4591001
1120
11201172 1 13AUG2020 Fatigue N Sev Mild N N N N 15AUG2020 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492706
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1120
11201250 2 11SEP2020 Headache N Sev N N N N N 12SEP2020 1
New or
worsened
joint pain N Sev N N N Mod Mild
C4591001
1125
11251243 1 08DEC2020 Fatigue N Mod Sev N N N 10DEC2020 2
Headache N Sev Sev N N N 10DEC2020 2
C4591001
1126
11261208 2 04DEC2020 Headache N Sev N N N N N 05DEC2020 1
C4591001
1129
11291261 2 14DEC2020 Headache Sev Sev N N N N N 15DEC2020 2
C4591001
1129
11291262 2 14DEC2020 Fatigue Sev Mild Mild N N N N 16DEC2020 3
C4591001
1135
11351088 2 28AUG2020 Fatigue Mild Sev N N N N N 29AUG2020 2
C4591001
1139
11391160 2 29DEC2020 Oral
temperature
(°C) 36.3 38.9 36.2 36.8 30DEC2020 1
C4591001
1140
11401316 2 14DEC2020 Headache Mild Sev N N N N N 15DEC2020 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492707
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
Chills N Sev N N N N N 15DEC2020 1
C4591001
1140
11401320 2 23DEC2020 Fatigue Mild Sev N N N N N 24DEC2020 2
C4591001
1140
11401321 1 04DEC2020 Fatigue Mod Sev Mod N N N N 06DEC2020 3
C4591001
1140
11401322 2 23DEC2020 Fatigue Mod Sev Mod Mild N 26DEC2020 4
Headache Mod Sev Mild N N 25DEC2020 3
C4591001
1141
11411081 1 14AUG2020 Fatigue N Sev N N N N N 15AUG2020 1
C4591001
1142
11421336 2 23DEC2020 Headache N N N N Sev N 28DEC2020 1
C4591001
1147
11471255 2 05DEC2020 Oral
temperature
(°C) 37.1 39.5 37.1 37.1 37.2 37.1 37 06DEC2020 1
Chills N Sev N N N N N 06DEC2020 1
C4591001
1152
11521072 2 01SEP2020 Diarrhea N N Sev Mild N N 04SEP2020 2
C4591001
1152
11521600 2 15DEC2020 Oral
temperature
(°C) 36.8 37.3 39 36.7 36.6 36.8 36.9 17DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492708
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1152
11521630 2 28DEC2020 Headache N Sev N N N N N 29DEC2020 1
C4591001
1152
11521632 1 07DEC2020 Chills Mod Sev Mild N N 09DEC2020 3
2 28DEC2020 Fatigue N Sev Mild N N N 30DEC2020 2
Headache N Sev Mild N N N 30DEC2020 2
C4591001
1156
11561299 1 11NOV2020 Fatigue N Mild Mod N N Sev N 16NOV2020 5
C4591001
1156
11561300 1 17NOV2020 Oral
temperature
(°C) 36.9 38.9 35.4 36.5 37.1 36.4 18NOV2020 19NOV2020 12
C4591001
1162
11621044 1 06AUG2020 Oral
temperature
(°C) 36.1 40 37.6 11AUG2020 1
Fatigue N Sev Sev 13AUG2020 3
Headache N Sev Sev 13AUG2020 3
Chills Mild Sev Mod 13AUG2020 6
New or
worsened
muscle pain N Sev N 11AUG2020 1
C4591001
1162
11621080 2 02SEP2020 Headache N Sev Mod N N N 04SEP2020 2
Chills N Sev Mod N N N 04SEP2020 2
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492709
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1162
11621110 2 02SEP2020 Fatigue Sev N N N N N 03SEP2020 1
C4591001
1171
11711027 1 14AUG2020 Chills N Sev N N N N N 15AUG2020 1
C4591001
1194
11941062 2 11NOV2020 Fatigue Mod Sev Mild Mild N N N 14NOV2020 4
C4591001
1194
11941069 2 11NOV2020 Fatigue Sev Sev Mild N N N N 13NOV2020 3
C4591001
1195
11951100 1 18OCT2020 Vomiting Sev N N N N N 18OCT2020 1
C4591001
1205
12051079 1 11NOV2020 Headache Mild Sev N N Mild N Mod 18NOV2020 8
2 02DEC2020 Headache Mod Sev N N N N N 03DEC2020 2
Chills Mild Sev N N N N N 03DEC2020 2
New or
worsened
muscle pain N Sev N N N N N 03DEC2020 1
New or
worsened
joint pain N Sev N N N N N 03DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492710
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1208
12081051 2 01DEC2020 Fatigue Mod Sev Mod N N N 03DEC2020 3
C4591001
1212
12121007 2 17NOV2020 Oral
temperature
(°C) 36.9 39.5 37.5 36.9 36.8 36.6 37 18NOV2020 1
Fatigue Mod Sev Mod N N N N 19NOV2020 3
New or
worsened
muscle pain N Sev Mod N N N N 19NOV2020 2
C4591001
1214
12141053 2 02DEC2020 Headache N N N N N N Sev 08DEC2020 1
C4591001
1217
12171053 1 06NOV2020 Fatigue N Sev N N N N 07NOV2020 1
2 26NOV2020 Fatigue N Sev N N N N 27NOV2020 1
C4591001
1223
12231057 1 01SEP2020 Headache N Sev Mild N N N N 03SEP2020 2
C4591001
1224
12241168 2 10DEC2020 Chills Mod Sev N N N N N 11DEC2020 2
C4591001
1224
12241171 1 23NOV2020 Fatigue N Sev N N N N N 24NOV2020 1
Headache N Sev N N N N N 24NOV2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492711
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1224
12241173 2 21DEC2020 New or
worsened
muscle pain N Sev N N N 22DEC2020 1
C4591001
1224
12241176 1 30NOV2020 Chills N Sev N N N N N 01DEC2020 1
C4591001
1224
12241178 1 30NOV2020 Fatigue Mild Sev N N N N N 01DEC2020 2
Chills N Sev N N N N N 01DEC2020 1
2 29DEC2020 Chills Mild Sev Mild N N N N 31DEC2020 3
C4591001
1226
12261001 2 25AUG2020 New or
worsened
muscle pain Mod Sev N N N 26AUG2020 2
C4591001
1226
12261096 1 11AUG2020 Fatigue N Sev Mod N N N N 13AUG2020 2
Headache N Sev Mod N N N N 13AUG2020 2
New or
worsened
muscle pain N Sev Mild N N N N 13AUG2020 2
New or
worsened
joint pain N Sev Mild Mild N N N 14AUG2020 3
2 01SEP2020 Fatigue N Sev N N N N N 02SEP2020 1
C4591001
1226
12261124 2 04SEP2020 Fatigue N Sev N N N N 05SEP2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492712
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1229
12291065 1 30SEP2020 Chills Mod Mild Mild Mod Sev N N 04OCT2020 5
2 21OCT2020 Fatigue Mild N Mod N N Sev N 26OCT2020 6
New or
worsened
muscle pain N Mild N N N Sev Mod 27OCT2020 6
C4591001
1230
12301018 1 24SEP2020 New or
worsened
muscle pain Mod Sev N N N N N 25SEP2020 2
New or
worsened
joint pain N Sev N N N N N 25SEP2020 1
C4591001
1230
12301094 1 01OCT2020 Headache N Sev Sev N N N N 03OCT2020 2
C4591001
1230
12301102 2 23OCT2020 Headache N Mod N Mod N Sev N 28OCT2020 5
C4591001
1231
12311018 2 27AUG2020 Headache N Sev N N N N N 28AUG2020 1
C4591001
1231
12311055 2 01SEP2020 Oral
temperature
(°C) 36.7 39 37.2 36.7 36.5 36.6 02SEP2020 1
Fatigue N Sev N N Mod N 06SEP2020 5
Chills N Sev N N N N 02SEP2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492713
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1231
12311164 2 02SEP2020 Fatigue N Sev Mild Mild N Mild Mild 09SEP2020 7
Chills N Sev N N N N N 03SEP2020 1
C4591001
1231
12311266 2 02SEP2020 Oral
temperature
(°C) 37.4 39.1 37.9 36.2 36.4 36.3 36.2 03SEP2020 1
C4591001
1231
12311281 2 04SEP2020 New or
worsened
muscle pain Mild Sev N N N N N 05SEP2020 2
C4591001
1231
12311306 1 15AUG2020 Headache N Mod N Sev N N N 18AUG2020 3
C4591001
1231
12311368 2 04SEP2020 Oral
temperature
(°C) 36 39.1 39.2 35.8 35.9 36.6 35.9 06SEP2020 2
C4591001
1231
12311432 1 15AUG2020 Headache N Sev Mild Mild Mild N N 19AUG2020 4
C4591001
1231
12311454 2 03SEP2020 Fatigue Mild Sev N N N N N 04SEP2020 2
C4591001
1231
12311463 1 15AUG2020 Fatigue Mild Mod Mild N N Sev Mild 23AUG2020 9
C4591001
1235
12351237 2 28DEC2020 New or
worsened
joint pain N Sev N N N N N 29DEC2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492714
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001
1235
12351241 2 28DEC2020 Headache Mild Sev Mild Mild Mild N N 01JAN2021 5
C4591001
1246
12461038 2 20OCT2020 Diarrhea N Sev Mild N N 22OCT2020 2
C4591001
1247
12471010 1 23SEP2020 Headache Mild Mild Mod N Mod Mild Sev 29SEP2020 7
C4591001
1247
12471033 2 15OCT2020 New or
worsened
muscle pain N Sev Sev N N 19OCT2020 2
C4591001
1247
12471121 1 30SEP2020 Oral
temperature
(°C) 39.2 39.8 39.1 39.2 39 38.8 38.9 06OCT2020 7
Fatigue Mod Mod Mod Sev Mod Mod Mod 06OCT2020 7
Headache Mod Sev Mod Mod Mod Mild Mod 06OCT2020 7
2 21OCT2020 Oral
temperature
(°C) 38.9 40 39.6 39.3 38.2 38.9 38.8
Fatigue Mod Mod Mod Mod Mod Mod Sev
C4591001
1247
12471145 2 22OCT2020 Headache Mild N Sev N N 26OCT2020 4
C4591001
1270
12701165 1 23NOV2020 Fatigue N Sev N N N N N 24NOV2020 1
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492715
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic
Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
Abbreviations: Dur = duration; Mod = moderate; N = none; Sev = severe.
Note: Subject C4591001 1077 10771278 (13 years of age) experienced systemic events, including a temperature of 40.4°C, on the day of Dose 2. Since these
events were recorded as adverse events and not in the electronic diary (e-diary), they do not appear in this listing.
Note: * = Systemic events recorded by the investigator on the AE log page.
a. Relative day (Rel Day) = date of event - date of last vaccination + 1.
b. Stop date is the date the event was last reported.
c. Duration (days) was calculated as the difference from the start of the first reported event to resolution of the last reported event, inclusive. If the event
continued beyond Day 7, the ca lculation includes all days from the last e -diary day until the date of resolution collected on the case report form. If the event is
ongoing at the time of the subsequent vaccination, the end date/day for the event is the date/day that the next vaccine wa s administered, which was used for the
duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:2229APR2021 (21:11) Source Data: adfacevd Table Generation: 27MAR2021
(01:55 25JAN2022 (04:07)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA Peds EDIARY /adce_l004_sevse_ped
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492716
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492717
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492718
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492719
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492720
090177e19939f70b\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492721