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Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety
Population ...................................................................................................................................................................................................................................... 2
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety
Population ...................................................................................................................................................................................................................................... 5
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Requested Subgroup – Subjects With or Without Evidence of Infectio n Prior
to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population ............................................................................................................................................. 13
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014040
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
1 Rednessd
Any 4907 262 (5.3) (4.7, 6.0) 4897 48 (1.0) (0.7, 1.3)
Mild 4907 184 (3.7) (3.2, 4.3) 4897 32 (0.7) (0.4, 0.9)
Moderate 4907 66 (1.3) (1.0, 1.7) 4897 11 (0.2) (0.1, 0.4)
Severe 4907 12 (0.2) (0.1, 0.4) 4897 5 (0.1) (0.0, 0.2)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Swellingd
Any 4907 325 (6.6) (5.9, 7.4) 4897 39 (0.8) (0.6, 1.1)
Mild 4907 211 (4.3) (3.7, 4.9) 4897 17 (0.3) (0.2, 0.6)
Moderate 4907 106 (2.2) (1.8, 2.6) 4897 20 (0.4) (0.2, 0.6)
Severe 4907 8 (0.2) (0.1, 0.3) 4897 2 (0.0) (0.0, 0.1)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Pain at the injection sitee
Any 4907 3834 (78.1) (77.0, 79.3) 4897 599 (12.2) (11.3, 13.2)
Mild 4907 2572 (52.4) (51.0, 53.8) 4897 568 (11.6) (10.7, 12.5)
Moderate 4907 1219 (24.8) (23.6, 26.1) 4897 28 (0.6) (0.4, 0.8)
Severe 4907 43 (0.9) (0.6, 1.2) 4897 3 (0.1) (0.0, 0.2)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Any local reactionf 4907 3877 (79.0) (77.8, 80.1) 4897 639 (13.0) (12.1, 14.0)
2 Rednessd
Any 4542 284 (6.3) (5.6, 7.0) 4517 32 (0.7) (0.5, 1.0)
Mild 4542 155 (3.4) (2.9, 4.0) 4517 22 (0.5) (0.3, 0.7)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014041
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 4542 108 (2.4) (2.0, 2.9) 4517 9 (0.2) (0.1, 0.4)
Severe 4542 21 (0.5) (0.3, 0.7) 4517 1 (0.0) (0.0, 0.1)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Swellingd
Any 4542 328 (7.2) (6.5, 8.0) 4517 18 (0.4) (0.2, 0.6)
Mild 4542 190 (4.2) (3.6, 4.8) 4517 8 (0.2) (0.1, 0.3)
Moderate 4542 127 (2.8) (2.3, 3.3) 4517 9 (0.2) (0.1, 0.4)
Severe 4542 11 (0.2) (0.1, 0.4) 4517 1 (0.0) (0.0, 0.1)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Pain at the injection sitee
Any 4542 3331 (73.3) (72.0, 74.6) 4517 455 (10.1) (9.2, 11.0)
Mild 4542 2147 (47.3) (45.8, 48.7) 4517 422 (9.3) (8.5, 10.2)
Moderate 4542 1135 (25.0) (23.7, 26.3) 4517 33 (0.7) (0.5, 1.0)
Severe 4542 49 (1.1) (0.8, 1.4) 4517 0 (0.0, 0.1)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Any local reactionf 4542 3351 (73.8) (72.5, 75.1) 4517 483 (10.7) (9.8, 11.6)
Any dose Rednessd
Any 4924 486 (9.9) (9.1, 10.7) 4915 72 (1.5) (1.1, 1.8)
Mild 4924 300 (6.1) (5.4, 6.8) 4915 47 (1.0) (0.7, 1.3)
Moderate 4924 153 (3.1) (2.6, 3.6) 4915 20 (0.4) (0.2, 0.6)
Severe 4924 33 (0.7) (0.5, 0.9) 4915 5 (0.1) (0.0, 0.2)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014042
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Swellingd
Any 4924 546 (11.1) (10.2, 12.0) 4915 51 (1.0) (0.8, 1.4)
Mild 4924 329 (6.7) (6.0, 7.4) 4915 21 (0.4) (0.3, 0.7)
Moderate 4924 198 (4.0) (3.5, 4.6) 4915 27 (0.5) (0.4, 0.8)
Severe 4924 19 (0.4) (0.2, 0.6) 4915 3 (0.1) (0.0, 0.2)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
Pain at the injection sitee
Any 4924 4153 (84.3) (83.3, 85.3) 4915 849 (17.3) (16.2, 18.4)
Mild 4924 2356 (47.8) (46.4, 49.3) 4915 789 (16.1) (15.0, 17.1)
Moderate 4924 1709 (34.7) (33.4, 36.1) 4915 57 (1.2) (0.9, 1.5)
Severe 4924 88 (1.8) (1.4, 2.2) 4915 3 (0.1) (0.0, 0.2)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
Any local reactionf 4924 4187 (85.0) (84.0, 86.0) 4915 903 (18.4) (17.3, 19.5)
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 cate gory only).
e. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergen cy 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 (19:22) Source Data: adfacevd Table Generation: 07APR2021 (17:02)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unbli nded/C4591001_BLA1/adce_s010_lr_16_p3_saf
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014043
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
1 Fever
≥38.0°C 4907 145 (3.0) (2.5, 3.5) 4897 33 (0.7) (0.5, 0.9)
≥38.0°C to 38.4°C 4907 109 (2.2) (1.8, 2.7) 4897 19 (0.4) (0.2, 0.6)
>38.4°C to 38.9°C 4907 27 (0.6) (0.4, 0.8) 4897 8 (0.2) (0.1, 0.3)
>38.9°C to 40.0°C 4907 9 (0.2) (0.1, 0.3) 4897 6 (0.1) (0.0, 0.3)
>40.0°C 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Fatigued
Any 4907 2108 (43.0) (41.6, 44.4) 4897 1407 (28.7) (27.5, 30.0)
Mild 4907 1175 (23.9) (22.8, 25.2) 4897 851 (17.4) (16.3, 18.5)
Moderate 4907 889 (18.1) (17.0, 19.2) 4897 535 (10.9) (10.1, 11.8)
Severe 4907 44 (0.9) (0.7, 1.2) 4897 21 (0.4) (0.3, 0.7)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Headached
Any 4907 1765 (36.0) (34.6, 37.3) 4897 1338 (27.3) (26.1, 28.6)
Mild 4907 1166 (23.8) (22.6, 25.0) 4897 900 (18.4) (17.3, 19.5)
Moderate 4907 564 (11.5) (10.6, 12.4) 4897 411 (8.4) (7.6, 9.2)
Severe 4907 35 (0.7) (0.5, 1.0) 4897 27 (0.6) (0.4, 0.8)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Chillsd
Any 4907 609 (12.4) (11.5, 13.4) 4897 268 (5.5) (4.9, 6.1)
Mild 4907 440 (9.0) (8.2, 9.8) 4897 197 (4.0) (3.5, 4.6)
Moderate 4907 154 (3.1) (2.7, 3.7) 4897 68 (1.4) (1.1, 1.8)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014044
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Severe 4907 15 (0.3) (0.2, 0.5) 4897 3 (0.1) (0.0, 0.2)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Vomitinge
Any 4907 44 (0.9) (0.7, 1.2) 4897 45 (0.9) (0.7, 1.2)
Mild 4907 38 (0.8) (0.5, 1.1) 4897 39 (0.8) (0.6, 1.1)
Moderate 4907 6 (0.1) (0.0, 0.3) 4897 5 (0.1) (0.0, 0.2)
Severe 4907 0 (0.0, 0.1) 4897 1 (0.0) (0.0, 0.1)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Diarrheaf
Any 4907 477 (9.7) (8.9, 10.6) 4897 453 (9.3) (8.5, 10.1)
Mild 4907 388 (7.9) (7.2, 8.7) 4897 373 (7.6) (6.9, 8.4)
Moderate 4907 82 (1.7) (1.3, 2.1) 4897 78 (1.6) (1.3, 2.0)
Severe 4907 7 (0.1) (0.1, 0.3) 4897 2 (0.0) (0.0, 0.1)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
New or worsened muscle paind
Any 4907 938 (19.1) (18.0, 20.2) 4897 494 (10.1) (9.3, 11.0)
Mild 4907 536 (10.9) (10.1, 11.8) 4897 342 (7.0) (6.3, 7.7)
Moderate 4907 386 (7.9) (7.1, 8.7) 4897 147 (3.0) (2.5, 3.5)
Severe 4907 16 (0.3) (0.2, 0.5) 4897 5 (0.1) (0.0, 0.2)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
New or worsened joint paind
Any 4907 517 (10.5) (9.7, 11.4) 4897 292 (6.0) (5.3, 6.7)
Mild 4907 319 (6.5) (5.8, 7.2) 4897 190 (3.9) (3.4, 4.5)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014045
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 4907 190 (3.9) (3.3, 4.5) 4897 100 (2.0) (1.7, 2.5)
Severe 4907 8 (0.2) (0.1, 0.3) 4897 2 (0.0) (0.0, 0.1)
Grade 4 4907 0 (0.0, 0.1) 4897 0 (0.0, 0.1)
Any systemic eventg 4907 2963 (60.4) (59.0, 61.8) 4897 2308 (47.1) (45.7, 48.5)
Use of antipyretic or pain medicationh 4907 1187 (24.2) (23.0, 25.4) 4897 622 (12.7) (11.8, 13.7)
2 Fever
≥38.0°C 4542 659 (14.5) (13.5, 15.6) 4517 15 (0.3) (0.2, 0.5)
≥38.0°C to 38.4°C 4542 412 (9.1) (8.3, 9.9) 4517 7 (0.2) (0.1, 0.3)
>38.4°C to 38.9°C 4542 200 (4.4) (3.8, 5.0) 4517 5 (0.1) (0.0, 0.3)
>38.9°C to 40.0°C 4542 46 (1.0) (0.7, 1.3) 4517 3 (0.1) (0.0, 0.2)
>40.0°C 4542 1 (0.0) (0.0, 0.1) 4517 0 (0.0, 0.1)
Fatigued
Any 4542 2598 (57.2) (55.7, 58.6) 4517 920 (20.4) (19.2, 21.6)
Mild 4542 949 (20.9) (19.7, 22.1) 4517 500 (11.1) (10.2, 12.0)
Moderate 4542 1446 (31.8) (30.5, 33.2) 4517 404 (8.9) (8.1, 9.8)
Severe 4542 202 (4.4) (3.9, 5.1) 4517 16 (0.4) (0.2, 0.6)
Grade 4 4542 1 (0.0) (0.0, 0.1) 4517 0 (0.0, 0.1)
Headached
Any 4542 2181 (48.0) (46.6, 49.5) 4517 911 (20.2) (19.0, 21.4)
Mild 4542 1163 (25.6) (24.3, 26.9) 4517 593 (13.1) (12.2, 14.1)
Moderate 4542 914 (20.1) (19.0, 21.3) 4517 295 (6.5) (5.8, 7.3)
Severe 4542 104 (2.3) (1.9, 2.8) 4517 23 (0.5) (0.3, 0.8)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014046
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Chillsd
Any 4542 1450 (31.9) (30.6, 33.3) 4517 171 (3.8) (3.2, 4.4)
Mild 4542 706 (15.5) (14.5, 16.6) 4517 134 (3.0) (2.5, 3.5)
Moderate 4542 654 (14.4) (13.4, 15.5) 4517 35 (0.8) (0.5, 1.1)
Severe 4542 90 (2.0) (1.6, 2.4) 4517 2 (0.0) (0.0, 0.2)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Vomitinge
Any 4542 71 (1.6) (1.2, 2.0) 4517 35 (0.8) (0.5, 1.1)
Mild 4542 52 (1.1) (0.9, 1.5) 4517 25 (0.6) (0.4, 0.8)
Moderate 4542 13 (0.3) (0.2, 0.5) 4517 10 (0.2) (0.1, 0.4)
Severe 4542 6 (0.1) (0.0, 0.3) 4517 0 (0.0, 0.1)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Diarrheaf
Any 4542 421 (9.3) (8.4, 10.1) 4517 307 (6.8) (6.1, 7.6)
Mild 4542 344 (7.6) (6.8, 8.4) 4517 245 (5.4) (4.8, 6.1)
Moderate 4542 69 (1.5) (1.2, 1.9) 4517 57 (1.3) (1.0, 1.6)
Severe 4542 8 (0.2) (0.1, 0.3) 4517 5 (0.1) (0.0, 0.3)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
New or worsened muscle paind
Any 4542 1592 (35.1) (33.7, 36.5) 4517 336 (7.4) (6.7, 8.2)
Mild 4542 670 (14.8) (13.7, 15.8) 4517 215 (4.8) (4.2, 5.4)
Moderate 4542 840 (18.5) (17.4, 19.7) 4517 117 (2.6) (2.1, 3.1)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014047
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Severe 4542 82 (1.8) (1.4, 2.2) 4517 4 (0.1) (0.0, 0.2)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
New or worsened joint paind
Any 4542 991 (21.8) (20.6, 23.0) 4517 219 (4.8) (4.2, 5.5)
Mild 4542 474 (10.4) (9.6, 11.4) 4517 126 (2.8) (2.3, 3.3)
Moderate 4542 481 (10.6) (9.7, 11.5) 4517 88 (1.9) (1.6, 2.4)
Severe 4542 36 (0.8) (0.6, 1.1) 4517 5 (0.1) (0.0, 0.3)
Grade 4 4542 0 (0.0, 0.1) 4517 0 (0.0, 0.1)
Any systemic eventg 4542 3237 (71.3) (69.9, 72.6) 4517 1542 (34.1) (32.8, 35.5)
Use of antipyretic or pain medicationh 4542 1901 (41.9) (40.4, 43.3) 4517 490 (10.8) (10.0, 11.8)
Any dose Fever
≥38.0°C 4924 749 (15.2) (14.2, 16.2) 4915 45 (0.9) (0.7, 1.2)
≥38.0°C to 38.4°C 4924 478 (9.7) (8.9, 10.6) 4915 25 (0.5) (0.3, 0.7)
>38.4°C to 38.9°C 4924 219 (4.4) (3.9, 5.1) 4915 12 (0.2) (0.1, 0.4)
>38.9°C to 40.0°C 4924 51 (1.0) (0.8, 1.4) 4915 8 (0.2) (0.1, 0.3)
>40.0°C 4924 1 (0.0) (0.0, 0.1) 4915 0 (0.0, 0.1)
Fatigued
Any 4924 3185 (64.7) (63.3, 66.0) 4915 1758 (35.8) (34.4, 37.1)
Mild 4924 1157 (23.5) (22.3, 24.7) 4915 956 (19.5) (18.4, 20.6)
Moderate 4924 1789 (36.3) (35.0, 37.7) 4915 769 (15.6) (14.6, 16.7)
Severe 4924 238 (4.8) (4.3, 5.5) 4915 33 (0.7) (0.5, 0.9)
Grade 4 4924 1 (0.0) (0.0, 0.1) 4915 0 (0.0, 0.1)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014048
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Headached
Any 4924 2814 (57.1) (55.8, 58.5) 4915 1717 (34.9) (33.6, 36.3)
Mild 4924 1458 (29.6) (28.3, 30.9) 4915 1075 (21.9) (20.7, 23.1)
Moderate 4924 1223 (24.8) (23.6, 26.1) 4915 593 (12.1) (11.2, 13.0)
Severe 4924 133 (2.7) (2.3, 3.2) 4915 49 (1.0) (0.7, 1.3)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
Chillsd
Any 4924 1707 (34.7) (33.3, 36.0) 4915 380 (7.7) (7.0, 8.5)
Mild 4924 870 (17.7) (16.6, 18.8) 4915 285 (5.8) (5.2, 6.5)
Moderate 4924 734 (14.9) (13.9, 15.9) 4915 90 (1.8) (1.5, 2.2)
Severe 4924 103 (2.1) (1.7, 2.5) 4915 5 (0.1) (0.0, 0.2)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
Vomitinge
Any 4924 110 (2.2) (1.8, 2.7) 4915 74 (1.5) (1.2, 1.9)
Mild 4924 86 (1.7) (1.4, 2.2) 4915 58 (1.2) (0.9, 1.5)
Moderate 4924 18 (0.4) (0.2, 0.6) 4915 15 (0.3) (0.2, 0.5)
Severe 4924 6 (0.1) (0.0, 0.3) 4915 1 (0.0) (0.0, 0.1)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
Diarrheaf
Any 4924 758 (15.4) (14.4, 16.4) 4915 659 (13.4) (12.5, 14.4)
Mild 4924 603 (12.2) (11.3, 13.2) 4915 524 (10.7) (9.8, 11.6)
Moderate 4924 140 (2.8) (2.4, 3.3) 4915 128 (2.6) (2.2, 3.1)
Severe 4924 15 (0.3) (0.2, 0.5) 4915 7 (0.1) (0.1, 0.3)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014049
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
New or worsened muscle paind
Any 4924 1980 (40.2) (38.8, 41.6) 4915 692 (14.1) (13.1, 15.1)
Mild 4924 826 (16.8) (15.7, 17.8) 4915 442 (9.0) (8.2, 9.8)
Moderate 4924 1059 (21.5) (20.4, 22.7) 4915 241 (4.9) (4.3, 5.5)
Severe 4924 95 (1.9) (1.6, 2.4) 4915 9 (0.2) (0.1, 0.3)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
New or worsened joint paind
Any 4924 1232 (25.0) (23.8, 26.3) 4915 442 (9.0) (8.2, 9.8)
Mild 4924 586 (11.9) (11.0, 12.8) 4915 259 (5.3) (4.7, 5.9)
Moderate 4924 602 (12.2) (11.3, 13.2) 4915 176 (3.6) (3.1, 4.1)
Severe 4924 44 (0.9) (0.7, 1.2) 4915 7 (0.1) (0.1, 0.3)
Grade 4 4924 0 (0.0, 0.1) 4915 0 (0.0, 0.1)
Any systemic eventg 4924 3878 (78.8) (77.6, 79.9) 4915 2716 (55.3) (53.9, 56.7)
Use of antipyretic or pain medicationh 4924 2301 (46.7) (45.3, 48.1) 4915 924 (18.8) (17.7, 19.9)
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 subjec ts 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. 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.
e. Mild: 1 to 2 t imes in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or
hospitalization for severe vomiting.
f. 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
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014050
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
visit or hospitalization for severe diarrhea.
g. 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.
h. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adfacevd Table Generation: 07APR2021 (17:15)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA1/adce s020 se 16 p3 saf
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014051
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Requested Subgroup – Subjects With or
Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19965)
Placebo
(Na=20172)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
First COVID -19 occurrence from 7 days after Dose 2
Overall 9 2.332 (18559) 169 2.345 (18708) 94.6 (89.6, 97.6)
Age group (years)
12 to 15 0 0.000 (14) 0 0.000 (14) NE (NE, NE)
16 to 17 0 0.003 (58) 1 0.003 (61) 100.0 (-3969.9, 100.0)
18 to 64 8 1.799 (14443) 149 1.811 (14566) 94.6 (89.1, 97.7)
65 to 74 1 0.424 (3239) 14 0.423 (3255) 92.9 (53.2, 99.8)
≥75 0 0.106 (805) 5 0.109 (812) 100.0 (-12.1, 100.0)
Race
White 7 1.975 (15294) 153 1.990 (15473) 95.4 (90.3, 98.2)
Black or African American 0 0.187 (1758) 7 0.188 (1758) 100.0 (30.4, 100.0)
American Indian or Alaska native 0 0.011 (104) 1 0.010 (104) 100.0 (-3511.0, 100.0)
Asian 1 0.095 (796) 4 0.097 (808) 74.4 (-158.7, 99.5)
Native Hawaiian or other Pacific Islander 0 0.006 (50) 1 0.003 (29) 100.0 (-2112.1, 100.0)
Multiracial 1 0.047 (467) 1 0.042 (424) 10.4 (-6934.9, 98.9)
Not reported 0 0.010 (90) 2 0.013 (112) 100.0 (-581.6, 100.0)
Baseline SARS -CoV -2 status
Positivef 1 0.056 (526) 1 0.060 (567) -7.1 (-8309.9, 98.6)
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014052
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Requested Subgroup – Subjects With or
Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19965)
Placebo
(Na=20172)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
Negativeg 8 2.237 (17637) 164 2.242 (17720) 95.1 (90.1, 97.9)
Unknown 0 0.039 (396) 4 0.043 (421) 100.0 (-68.9, 100.0)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test; SARS -CoV -2 = severe acute respiratory
syndrome coronavirus 2; VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
f. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19.
g. Negative N -binding antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID -19.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (09:54) Source Data: adc19ef Table Generation: 23NOV2020 (16:39)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_EUA_FAEF_RR/adc19ef_ve_cov_7pd2_req_sg_eval
090177e196f540c4\Final\Final On: 05-May-2021 15:03 (GMT)
FDA-CBER-2021-5683-0014053