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 ............................................................................................................................................................................................................................................. 8
Onset Days for Local Reactions – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population ................................... 10
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 ................................................................................................................................................................................................................................ 13
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 ........................................................................................................................................................................................................................................... 22
Onset Days for S ystemic Events – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population .................................. 28
Listing of Sev ere and Grade 4 Local Reactions – Subjects 12 Through 25 Years of Age (Reactogenicity Subset) .......................................................................... 33
Listing of Severe and Grade 4 Systemic Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset) .......................................................................... 37
Subjects Reporting Local Reactions, by Maximum Sever ity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age
(Reactogenicity Subset) – Safety Population ...................................................................................................................................................................................... 59
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 ...................................................................................................................................................................................... 60
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492722
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) 2 (0.2) 8 (1.4)
Transmittedd
Day 1 1081 (95.6) 509 (94.8) 1066 (94.4) 514 (91.6)
Day 2 1090 (96.4) 512 (95.3) 1073 (95.0) 519 (92.5)
Day 3 1049 (92.7) 488 (90.9) 1056 (93.5) 515 (91.8)
Day 4 1025 (90.6) 480 (89.4) 1011 (89.5) 504 (89.8)
Day 5 1012 (89.5) 473 (88.1) 1003 (88.8) 492 (87.7)
Day 6 991 (87.6) 476 (88.6) 1002 (88.8) 484 (86.3)
Day 7 1006 (88.9) 478 (89.0) 990 (87.7) 476 (84.8)
All 7 dayse 719 (63.6) 349 (65.0) 697 (61.7) 344 (61.3)
Vaccinated at Dose 2b 1124 525 1117 535
E-diary
Not transmittedc 23 (2.0) 31 (5.9) 38 (3.4) 38 (7.1)
Transmittedd
Day 1 858 (76.3) 381 (72.6) 786 (70.4) 350 (65.4)
Day 2 991 (88.2) 446 (85.0) 881 (78.9) 408 (76.3)
Day 3 963 (85.7) 424 (80.8) 905 (81.0) 428 (80.0)
Day 4 914 (81.3) 420 (80.0) 907 (81.2) 431 (80.6)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492723
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) 423 (80.6) 909 (81.4) 433 (80.9)
Day 6 931 (82.8) 414 (78.9) 923 (82.6) 425 (79.4)
Day 7 925 (82.3) 412 (78.5) 912 (81.6) 427 (79.8)
All 7 dayse 465 (41.4) 220 (41.9) 415 (37.2) 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
page for Day 1 through Day 7 after vaccination, th e 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 transmitted.
e. "All 7 days" includes Day 1 through Day 7 after vaccination. Day 1 is the day of vaccination.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (21:11) Source Data: adfacevd Table Generation: 25JAN2022 (02:18)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_Peds_EDIARY/adce_s200_trns_ped_saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492724
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
Dose 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) 553 7 (1.3) (0.5, 2.6)
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) 553 6 (1.1) (0.4, 2.3)
Moderate 1127 20 (1.8) (1.1, 2.7) 531 7 (1.3) (0.5, 2.7) 1127 1 (0.1) (0.0, 0.5) 553 1 (0.2) (0.0, 1.0)
Severe 1127 1 (0.1) (0.0, 0.5) 531 2 (0.4) (0.0, 1.4) 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)
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) 553 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) 553 3 (0.5) (0.1, 1.6)
Moderate 1127 23 (2.0) (1.3, 3.0) 531 12 (2.3) (1.2, 3.9) 1127 2 (0.2) (0.0, 0.6) 553 3 (0.5) (0.1, 1.6)
Severe 1127 0 (0.0, 0.3) 531 1 (0.2) (0.0, 1.0) 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)
Pain at the injection
sitee
Any 1127 973 (86.3) (84.2, 88.3) 532 444 (83.5) (80.0, 86.5) 1127 267 (23.7) (21.2, 26.3) 553 88 (15.9) (13.0, 19.2)
Mild 1127 469 (41.6) (38.7, 44.6) 532 203 (38.2) (34.0, 42.4) 1127 231 (20.5) (18.2, 23.0) 553 81 (14.6) (11.8, 17.9)
Moderate 1127 493 (43.7) (40.8, 46.7) 532 229 (43.0) (38.8, 47.4) 1127 36 (3.2) (2.2, 4.4) 553 7 (1.3) (0.5, 2.6)
Severe 1127 11 (1.0) (0.5, 1.7) 532 12 (2.3) (1.2, 3.9) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Grade 4 1127 0 (0.0, 0.3) 532 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Any local reactionf 1127 978 (86.8) (84.7, 88.7) 532 446 (83.8) (80.4, 86.9) 1127 275 (24.4) (21.9, 27.0) 553 93 (16.8) (13.8, 20.2)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492725
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
Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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) 496 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) 496 1 (0.2) (0.0, 1.1)
Moderate 1097 26 (2.4) (1.6, 3.5) 488 9 (1.8) (0.8, 3.5) 1078 2 (0.2) (0.0, 0.7) 496 0 (0.0, 0.7)
Severe 1097 0 (0.0, 0.3) 488 1 (0.2) (0.0, 1.1) 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)
Swellingd
Any 1098 55 (5.0) (3.8, 6.5) 489 34 (7.0) (4.9, 9.6) 1078 6 (0.6) (0.2, 1.2) 496 1 (0.2) (0.0, 1.1)
Mild 1098 36 (3.3) (2.3, 4.5) 489 24 (4.9) (3.2, 7.2) 1078 4 (0.4) (0.1, 0.9) 496 1 (0.2) (0.0, 1.1)
Moderate 1098 19 (1.7) (1.0, 2.7) 489 10 (2.0) (1.0, 3.7) 1078 2 (0.2) (0.0, 0.7) 496 0 (0.0, 0.7)
Severe 1098 0 (0.0, 0.3) 489 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Grade 4 1098 0 (0.0, 0.3) 489 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Pain at the injection
sitee
Any 1101 870 (79.0) (76.5, 81.4) 490 380 (77.6) (73.6, 81.2) 1079 194 (18.0) (15.7, 20.4) 496 61 (12.3) (9.5, 15.5)
Mild 1101 467 (42.4) (39.5, 45.4) 490 204 (41.6) (37.2, 46.1) 1079 165 (15.3) (13.2, 17.6) 496 54 (10.9) (8.3, 14.0)
Moderate 1101 396 (36.0) (33.1, 38.9) 490 169 (34.5) (30.3, 38.9) 1079 29 (2.7) (1.8, 3.8) 496 7 (1.4) (0.6, 2.9)
Severe 1101 7 (0.6) (0.3, 1.3) 490 7 (1.4) (0.6, 2.9) 1079 0 (0.0, 0.3) 496 0 (0.0, 0.7)
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)
Any local reactionf 1101 876 (79.6) (77.1, 81.9) 490 383 (78.2) (74.2, 81.7) 1079 199 (18.4) (16.2, 20.9) 496 63 (12.7) (9.9, 16.0)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492726
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
Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any
dose 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) 555 7 (1.3) (0.5, 2.6)
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) 555 6 (1.1) (0.4, 2.3)
Moderate 1131 41 (3.6) (2.6, 4.9) 535 15 (2.8) (1.6, 4.6) 1129 3 (0.3) (0.1, 0.8) 555 1 (0.2) (0.0, 1.0)
Severe 1131 1 (0.1) (0.0, 0.5) 535 3 (0.6) (0.1, 1.6) 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)
Swellingd
Any 1131 104 (9.2) (7.6, 11.0) 535 62 (11.6) (9.0, 14.6) 1129 13 (1.2) (0.6, 2.0) 555 7 (1.3) (0.5, 2.6)
Mild 1131 68 (6.0) (4.7, 7.6) 535 45 (8.4) (6.2, 11.1) 1129 10 (0.9) (0.4, 1.6) 555 4 (0.7) (0.2, 1.8)
Moderate 1131 36 (3.2) (2.2, 4.4) 535 16 (3.0) (1.7, 4.8) 1129 3 (0.3) (0.1, 0.8) 555 3 (0.5) (0.1, 1.6)
Severe 1131 0 (0.0, 0.3) 535 1 (0.2) (0.0, 1.0) 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)
Pain at the injection
sitee
Any 1131 1024 (90.5) (88.7, 92.2) 535 468 (87.5) (84.4, 90.2) 1129 344 (30.5) (27.8, 33.2) 555 122 (22.0) (18.6, 25.7)
Mild 1131 393 (34.7) (32.0, 37.6) 535 167 (31.2) (27.3, 35.3) 1129 286 (25.3) (22.8, 28.0) 555 109 (19.6) (16.4, 23.2)
Moderate 1131 614 (54.3) (51.3, 57.2) 535 283 (52.9) (48.6, 57.2) 1129 58 (5.1) (3.9, 6.6) 555 13 (2.3) (1.3, 4.0)
Severe 1131 17 (1.5) (0.9, 2.4) 535 18 (3.4) (2.0, 5.3) 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)
Any local reactionf 1131 1029 (91.0) (89.2, 92.6) 535 471 (88.0) (85.0, 90.7) 1129 352 (31.2) (28.5, 34.0) 555 127 (22.9) (19.5, 26.6)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492727
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
Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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: 29APR2021 (21:11) Source Data: adfacevd Table Generation: 21JAN2022 (09:17)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unbli nded/C4591001 sBLA Peds EDIARY/adce s010 lr sev ped saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492728
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 7
Mean (SD) 2.4 (2.26) 1.8 (0.97) 1.3 (0.62) 1.3 (0.49)
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 973 444 267 88
Mean (SD) 2.4 (1.35) 2.3 (1.37) 2.0 (1.73) 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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492729
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 55 34 6 1
Mean (SD) 1.7 (0.93) 2.3 (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 870 380 194 61
Mean (SD) 2.5 (1.38) 2.8 (4.30) 1.8 (1.43) 2.2 (4.42)
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 C reation: 29APR2021 (21:06) Source Data: adcevd Table Generation: 21JAN2022 (09:17)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 sBLA Peds EDIARY/adce s030 lr dur p ed saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492730
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 7
Mean (SD) 2.4 (0.82) 2.4 (1.05) 1.8 (1.11) 1.6 (1.13)
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 973 444 267 88
Mean (SD) 1.4 (0.55) 1.4 (0.50) 1.3 (0.83) 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 978 446 275 93
Mean (SD) 1.4 (0.56) 1.4 (0.51) 1.4 (0.87) 1.5 (1.05)
Median 1.0 1.0 1.0 1.0
Min, max (1, 7) (1, 4) (1, 7) (1, 7)
2 Redness
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492731
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 55 34 6 1
Mean (SD) 2.0 (0.96) 2.0 (0.97) 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 870 380 194 61
Mean (SD) 1.4 (0.61) 1.4 (0.62) 1.5 (1.13) 1.6 (1.05)
Median 1.0 1.0 1.0 1.0
Min, max (1, 6) (1, 6) (1, 7) (1, 6)
Any local reactionb
na 876 383 199 63
Mean (SD) 1.4 (0.62) 1.4 (0.63) 1.5 (1.08) 1.6 (1.05)
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 redness >2.0 cm, any swelling >2.0 c m, or any pain at the injection site.
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492732
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: 29APR2021 (21:11) Source Data: adfacevd Table Generation: 21JAN2022 (09:17)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_Peds_EDIAR Y/adce_s050_lr_onset_ped_saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492733
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
1 Fever
Any 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)
Fatiguee
Any 1127 678 (60.2) (57.2, 63.0) 532 319 (60.0) (55.7, 64.2) 1127 457 (40.6) (37.7, 43.5) 553 213 (38.5) (34.4, 42.7)
Mild 1127 279 (24.8) (22.3, 27.4) 532 135 (25.4) (21.7, 29.3) 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) 532 173 (32.5) (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) 532 11 (2.1) (1.0, 3.7) 1127 8 (0.7) (0.3, 1.4) 553 6 (1.1) (0.4, 2.3)
Grade 4 1127 0 (0.0, 0.3) 532 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Headachee
Any 1127 624 (55.4) (52.4, 58.3) 533 288 (54.0) (49.7, 58.3) 1127 396 (35.1) (32.3, 38.0) 553 205 (37.1) (33.0, 41.2)
Mild 1127 362 (32.1) (29.4, 34.9) 533 153 (28.7) (24.9, 32.8) 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) 533 124 (23.3) (19.7, 27.1) 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) 533 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) 533 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Chillse
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492734
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 1127 312 (27.7) (25.1, 30.4) 532 134 (25.2) (21.6, 29.1) 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) 532 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 112 (9.9) (8.3, 11.8) 532 38 (7.1) (5.1, 9.7) 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) 532 5 (0.9) (0.3, 2.2) 1127 2 (0.2) (0.0, 0.6) 553 1 (0.2) (0.0, 1.0)
Grade 4 1127 0 (0.0, 0.3) 532 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
Vomitingf
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)
Diarrheag
Any 1127 90 (8.0) (6.5, 9.7) 531 57 (10.7) (8.2, 13.7) 1127 83 (7.4) (5.9, 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 73 (6.5) (5.1, 8.1) 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 paine
Any 1127 272 (24.1) (21.7, 26.7) 532 144 (27.1) (23.3, 31.1) 1127 148 (13.1) (11.2, 15.2) 553 78 (14.1) (11.3, 17.3)
Mild 1127 125 (11.1) (9.3, 13.1) 532 67 (12.6) (9.9, 15.7) 1127 88 (7.8) (6.3, 9.5) 553 51 (9.2) (6.9, 11.9)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492735
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 1127 145 (12.9) (11.0, 15.0) 532 72 (13.5) (10.7, 16.7) 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) 532 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) 532 0 (0.0, 0.7) 1127 0 (0.0, 0.3) 553 0 (0.0, 0.7)
New or worsened joint
paine
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 eventh 1127 878 (77.9) (75.4, 80.3) 533 405 (76.0) (72.1, 79.6) 1127 637 (56.5) (53.6, 59.4) 553 311 (56.2) (52.0, 60.4)
Use of antipyretic or
pain medicationi 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)
2 Fever
Any 1098 217 (19.8) (17.4, 22.2) 489 88 (18.0) (14.7, 21.7) 1078 7 (0.6) (0.3, 1.3) 496 2 (0.4) (0.0, 1.4)
≥38.0°C to 38.4°C 1098 107 (9.7) (8.1, 11.7) 489 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 1098 83 (7.6) (6.1, 9.3) 489 32 (6.5) (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 1098 25 (2.3) (1.5, 3.3) 489 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 1098 0 (0.0, 0.3) 489 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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492736
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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
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)
Chillse
Any 1097 455 (41.5) (38.5, 44.5) 489 196 (40.1) (35.7, 44.6) 1079 74 (6.9) (5.4, 8.5) 496 22 (4.4) (2.8, 6.6)
Mild 1097 221 (20.1) (17.8, 22.6) 489 82 (16.8) (13.6, 20.4) 1079 53 (4.9) (3.7, 6.4) 496 17 (3.4) (2.0, 5.4)
Moderate 1097 214 (19.5) (17.2, 22.0) 489 102 (20.9) (17.3, 24.7) 1079 21 (1.9) (1.2, 3.0) 496 5 (1.0) (0.3, 2.3)
Severe 1097 20 (1.8) (1.1, 2.8) 489 12 (2.5) (1.3, 4.2) 1079 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Grade 4 1097 0 (0.0, 0.3) 489 0 (0.0, 0.8) 1079 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)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492737
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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)
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)
Diarrheag
Any 1098 67 (6.1) (4.8, 7.7) 488 39 (8.0) (5.7, 10.8) 1078 43 (4.0) (2.9, 5.3) 497 27 (5.4) (3.6, 7.8)
Mild 1098 59 (5.4) (4.1, 6.9) 488 32 (6.6) (4.5, 9.1) 1078 38 (3.5) (2.5, 4.8) 497 22 (4.4) (2.8, 6.6)
Moderate 1098 8 (0.7) (0.3, 1.4) 488 5 (1.0) (0.3, 2.4) 1078 5 (0.5) (0.2, 1.1) 497 5 (1.0) (0.3, 2.3)
Severe 1098 0 (0.0, 0.3) 488 2 (0.4) (0.0, 1.5) 1078 0 (0.0, 0.3) 497 0 (0.0, 0.7)
Grade 4 1098 0 (0.0, 0.3) 488 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 497 0 (0.0, 0.7)
New or worsened
muscle paine
Any 1098 358 (32.6) (29.8, 35.5) 489 201 (41.1) (36.7, 45.6) 1078 91 (8.4) (6.9, 10.3) 496 48 (9.7) (7.2, 12.6)
Mild 1098 154 (14.0) (12.0, 16.2) 489 94 (19.2) (15.8, 23.0) 1078 52 (4.8) (3.6, 6.3) 496 29 (5.8) (4.0, 8.3)
Moderate 1098 198 (18.0) (15.8, 20.4) 489 98 (20.0) (16.6, 23.9) 1078 37 (3.4) (2.4, 4.7) 496 18 (3.6) (2.2, 5.7)
Severe 1098 6 (0.5) (0.2, 1.2) 489 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 1098 0 (0.0, 0.3) 489 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
New or worsened joint
paine
Any 1097 173 (15.8) (13.7, 18.1) 489 108 (22.1) (18.5, 26.0) 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) 489 50 (10.2) (7.7, 13.3) 1078 30 (2.8) (1.9, 3.9) 496 14 (2.8) (1.6, 4.7)
Moderate 1097 78 (7.1) (5.7, 8.8) 489 54 (11.0) (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) 489 4 (0.8) (0.2, 2.1) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492738
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 1097 0 (0.0, 0.3) 489 0 (0.0, 0.8) 1078 0 (0.0, 0.3) 496 0 (0.0, 0.7)
Any systemic eventh 1101 910 (82.7) (80.3, 84.8) 492 400 (81.3) (77.6, 84.7) 1079 441 (40.9) (37.9, 43.9) 497 184 (37.0) (32.8, 41.4)
Use of antipyretic or
pain medicationi 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)
Any
dose Fever
Any 1131 277 (24.5) (22.0, 27.1) 535 117 (21.9) (18.4, 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)
Fatiguee
Any 1131 879 (77.7) (75.2, 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)
Mild 1131 240 (21.2) (18.9, 23.7) 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 599 (53.0) (50.0, 55.9) 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)
Headachee
Any 1131 855 (75.6) (73.0, 78.1) 535 387 (72.3) (68.3, 76.1) 1129 506 (44.8) (41.9, 47.8) 555 243 (43.8) (39.6, 48.0)
Mild 1131 323 (28.6) (25.9, 31.3) 535 141 (26.4) (22.7, 30.3) 1129 303 (26.8) (24.3, 29.5) 555 147 (26.5) (22.9, 30.4)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492739
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 1131 501 (44.3) (41.4, 47.2) 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)
Chillse
Any 1131 557 (49.2) (46.3, 52.2) 535 257 (48.0) (43.7, 52.4) 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) 535 124 (23.2) (19.7, 27.0) 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)
Vomitingf
Any 1131 60 (5.3) (4.1, 6.8) 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 55 (4.9) (3.7, 6.3) 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)
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)
Diarrheag
Any 1131 143 (12.6) (10.8, 14.7) 535 81 (15.1) (12.2, 18.5) 1129 107 (9.5) (7.8, 11.3) 555 76 (13.7) (10.9, 16.8)
Mild 1131 123 (10.9) (9.1, 12.8) 535 67 (12.5) (9.8, 15.6) 1129 92 (8.1) (6.6, 9.9) 555 58 (10.5) (8.0, 13.3)
Moderate 1131 20 (1.8) (1.1, 2.7) 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)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492740
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
New or worsened
muscle paine
Any 1131 479 (42.4) (39.5, 45.3) 535 262 (49.0) (44.7, 53.3) 1129 197 (17.4) (15.3, 19.8) 555 103 (18.6) (15.4, 22.0)
Mild 1131 188 (16.6) (14.5, 18.9) 535 107 (20.0) (16.7, 23.6) 1129 111 (9.8) (8.2, 11.7) 555 62 (11.2) (8.7, 14.1)
Moderate 1131 283 (25.0) (22.5, 27.7) 535 141 (26.4) (22.7, 30.3) 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
paine
Any 1131 229 (20.2) (17.9, 22.7) 535 142 (26.5) (22.8, 30.5) 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 62 (11.6) (9.0, 14.6) 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)
Any systemic eventh 1131 1027 (90.8) (89.0, 92.4) 535 473 (88.4) (85.4, 91.0) 1129 726 (64.3) (61.4, 67.1) 555 343 (61.8) (57.6, 65.9)
Use of antipyretic or
pain medicationi 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.
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. Only subjects with "Pyre xia, Body temperature increased" dictionary terms and non -missing AE toxicity grade recorded in AE and missing e -diary related
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492741
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
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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.
f. 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.
g. 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.
h. Any systemic event: any fever, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or
worsened joint pain.
i. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (21:11) Source Data: adfacevd Table Generation: 25JAN2022 (21:02)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBL A_Peds_EDIARY/adce_s020_se_sev_ped_saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492742
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 Fevera
nb 114 39 12 8
Mean (SD) 1.1 (0.48) 1.2 (0.54) 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)
Unknownc 0 0 0 1
Fatigue
nb 678 319 457 213
Mean (SD) 2.5 (3.20) 2.5 (2.11) 3.1 (2.92) 3.0 (2.68)
Median 2.0 2.0 2.0 2.0
Min, max (1, 45) (1, 11) (1, 22) (1, 15)
Unknownc 0 0 2 3
Headache
nb 624 288 396 205
Mean (SD) 2.4 (2.27) 2.5 (2.50) 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)
Unknownc 0 0 1 2
Chills
nb 312 134 109 47
Mean (SD) 1.6 (1.48) 1.5 (1.28) 2.6 (2.87) 2.3 (1.82)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492743
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)
Unknownc 1 1 2 1
Vomiting
nb 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
nb 90 57 83 62
Mean (SD) 1.6 (1.25) 1.7 (1.62) 1.7 (1.51) 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
nb 272 144 148 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)
Unknownc 0 1 0 1
New or worsened joint pain
nb 109 70 77 28
Mean (SD) 1.6 (1.33) 1.7 (2.83) 2.2 (2.88) 2.7 (2.60)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492744
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
nb 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)
Unknownc 0 0 1 2
2 Fevera
nb 217 88 7 2
Mean (SD) 1.1 (0.38) 1.1 (0.41) 3.0 (4.86) 1.0 (NE)
Median 1.0 1.0 1.0 1.0
Min, max (1, 6) (1, 3) (1, 14) (1, 1)
Unknownc 1 0 0 1
Fatigue
nb 732 323 265 116
Mean (SD) 2.1 (1.92) 2.3 (2.43) 2.8 (3.05) 3.2 (4.37)
Median 1.0 1.0 2.0 2.0
Min, max (1, 23) (1, 28) (1, 37) (1, 38)
Unknownc 4 3 2 4
Headache
nb 710 300 263 118
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492745
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 (2.15) 2.2 (3.09) 2.5 (2.39) 3.5 (5.64)
Median 1.0 1.0 1.0 1.0
Min, max (1, 36) (1, 42) (1, 23) (1, 35)
Unknownc 6 1 3 3
Chills
nb 455 196 74 22
Mean (SD) 1.5 (1.07) 1.3 (0.90) 2.1 (1.89) 2.0 (1.41)
Median 1.0 1.0 1.0 2.0
Min, max (1, 9) (1, 11) (1, 8) (1, 6)
Unknownc 1 1 1 1
Vomiting
nb 30 13 12 9
Mean (SD) 1.0 (0.18) 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
nb 67 39 43 27
Mean (SD) 2.1 (4.31) 1.4 (0.94) 1.5 (1.04) 4.2 (7.57)
Median 1.0 1.0 1.0 1.0
Min, max (1, 35) (1, 5) (1, 5) (1, 33)
Unknownc 1 0 1 1
New or worsened muscle pain
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492746
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
nb 358 201 91 48
Mean (SD) 1.7 (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)
Unknownc 1 1 0 0
New or worsened joint pain
nb 173 108 51 20
Mean (SD) 1.5 (1.26) 1.6 (2.74) 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)
Unknownc 2 2 0 0
Use of antipyretic or pain medication
nb 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)
Unknownc 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.
a. Includes subjects with "Pyrexia, Body temperature increased" dictionary terms and non -missing AE toxicity grade recorded in AE, and subjects with
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492747
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
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.
c. Includes those events where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (21:06) Source Data: adcevd Table Generation: 25JAN2022 (21:29)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_Peds_EDIARY/adce_s040_se_dur_p ed_saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492748
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 Fevera
nb 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
nb 678 319 457 213
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
nb 624 288 396 205
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
nb 312 134 109 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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492749
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
nb 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
nb 90 57 83 62
Mean (SD) 3.7 (1.79) 3.2 (1.48) 3.6 (1.86) 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
nb 272 144 148 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
nb 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 eventc
nb 878 405 637 311
Mean (SD) 1.8 (1.01) 1.8 (1.06) 2.0 (1.39) 2.1 (1.40)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492750
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
nb 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 Fevera
nb 217 88 7 2
Mean (SD) 2.0 (0.31) 2.0 (0.57) 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
nb 732 323 265 116
Mean (SD) 1.8 (0.67) 1.8 (0.79) 2.1 (1.59) 2.3 (1.48)
Median 2.0 2.0 2.0 2.0
Min, max (1, 7) (1, 7) (1, 7) (1, 7)
Headache
nb 710 300 263 118
Mean (SD) 1.9 (0.66) 2.0 (0.91) 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)
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492751
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
nb 455 196 74 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
nb 30 13 12 9
Mean (SD) 2.3 (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
nb 67 39 43 27
Mean (SD) 3.0 (1.57) 3.0 (1.48) 3.7 (2.06) 3.9 (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
nb 358 201 91 48
Mean (SD) 2.1 (0.83) 2.0 (0.72) 2.8 (1.94) 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
nb 173 108 51 20
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492752
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 eventc
nb 910 400 441 184
Mean (SD) 1.8 (0.77) 1.8 (0.87) 2.3 (1.71) 2.2 (1.47)
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
nb 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.
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, with each subject counted only once per event.
c. Any systemic event: any fever, 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: 29APR20 21 (21:11) Source Data: adfacevd Table Generation: 26JAN2022 (01:21)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_Peds_EDIARY/adce_s060_se_onset _ped_saf
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492753
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492754
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492755
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492756
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 injection site redness or swellin g 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 t o 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 ti me of the subsequent vaccination, the end date/day for the reaction is the date/day that the next vaccine was administered, w hich
was used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (21:11) Source Data: adfacevd Table Genera tion: 26JAN2022 (01:52)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_Peds_EDIARY/adce_l004_sevlr_pe d
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492757
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492758
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492759
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492760
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 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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492761
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
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492762
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 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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492763
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
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
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
C4591001 1126
11261307 1 04JAN2021 Chills N Sev N N N N N 05JAN2021 1
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492764
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492765
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492766
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 1142
11421392 2 29JAN2021 Chills Sev N N N N N 30JAN2021 1
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 35.9 36.4 08JAN2021 3
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492767
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
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
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 Sev* Sev* Sev* Sev* Sev* Sev Sev* 27DEC2020 7
Headache N N N N Sev 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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492768
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
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
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
16-25 C4591001 1001
10011125 1 04AUG2020 Fatigue Mod Mod Sev Mild N 07AUG2020 4
Headache Mod Mod Sev Mod N 07AUG2020 4
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492769
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
New or worsened
muscle pain N N Sev Sev* N 07AUG2020 2
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492770
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492771
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492772
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 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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492773
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
11521600 2 15DEC2020 Oral temperature (°C) 36.8 37.3 39 36.7 36.6 36.8 36.9 17DEC2020 1
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 36.5 37.1 36.4 19NOV2020 2
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492774
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 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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492775
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492776
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492777
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
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
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
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492778
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 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
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 calculation 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, th e end date/day for the event is the date/day that the next vaccine was administered, which was used for the
duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (21:11) Source Data: adfacevd Table Generation: 25JAN2022 (04:07)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 sBLA Peds EDIARY/adce l004 sevse ped
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492779
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492780
090177e19939f707\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492781