Document text
E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ............................................................................. 2
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age –
Safety Population .......................................................................................................................................................................................................................... 4
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase
2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population .............................................................................................................................................. 10
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status (Reactogenicity Subset) – Phase 2/3 Subjects
≥16 Years of Age – Safety Population ........................................................................................................................................................................................ 13
Duration (Days) From First to Last Day of Local Reactions, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety
Population .................................................................................................................................................................................................................................... 21
Duration (Days) From First to Last Day of Local Reactions (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -
Positive Subjects ≥16 Years of Age – Safety Population ............................................................................................................................................................ 25
Onset Days for Local Reactions, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ................................... 27
Onset Days for Local Reactions (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV- Positive Subjects ≥16 Years of
Age – Safety Population .............................................................................................................................................................................................................. 31
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥≥16 Years of Age –
Safety Population 16 Years of Age – Safety Population ............................................................................................................................................................. 33
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase
2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population .............................................................................................................................................. 51
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status (Reactogenicity Subset) – Phase 2/3 Subjects
≥16 Years of Age – Safety Population ........................................................................................................................................................................................ 59
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety
Population .................................................................................................................................................................................................................................... 76
Duration (Days) From First to Last Day of Systemic Events (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -
Positive Subjects ≥16 Years of Age – Safety Population ............................................................................................................................................................ 86
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population .................................. 91
Onset Days for Systemic Events (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of
Age – Safety Population ............................................................................................................................................................................................................ 100
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
na (%) na (%)
Vaccinated at Dose 1b 5033 5032
E-diary
Not transmittedc 72 (1.4) 79 (1.6)
Transmittedd
Day 1 4703 (93.4) 4657 (92.5)
Day 2 4733 (94.0) 4679 (93.0)
Day 3 4622 (91.8) 4674 (92.9)
Day 4 4583 (91.1) 4588 (91.2)
Day 5 4535 (90.1) 4582 (91.1)
Day 6 4562 (90.6) 4532 (90.1)
Day 7 4537 (90.1) 4548 (90.4)
All 7 dayse 3454 (68.6) 3461 (68.8)
Vaccinated at Dose 2b 4964 4934
E-diary
Not transmittedc 360 (7.3) 354 (7.2)
Transmittedd
Day 1 3799 (76.5) 3615 (73.3)
Day 2 4249 (85.6) 3966 (80.4)
Day 3 4197 (84.5) 4063 (82.3)
Day 4 4162 (83.8) 4110 (83.3)
Day 5 4179 (84.2) 4132 (83.7)
Day 6 4182 (84.2) 4127 (83.6)
Day 7 4160 (83.8) 4155 (84.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
na (%) na (%)
All 7 dayse 2718 (54.8) 2481 (50.3)
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary but analyzed and reported separately.
a. n = Number of subjects with the specified characteristic.
b. These values are the denominators for the percentage cal culations.
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 period ( Day 1 through Day 7 after vaccination,), the e -diary is considered not transmitted.
d. If any data for temperature, local reactions, fever/pain medication, or systemic events are reported for the specified day or set of days (ie, "all 7 days"),
the e -diary is considered 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 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:24 27MAR2021 (01:55)
(Cutoff Date: 13MA R2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ sBLA CBER EDIARY BLA /adce_s200_trns_p3_saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age Group Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
16-55 Years 1 Rednessd
Any 2899 158156 (5.54) (4.76, 6.3) 2908 3028 (1.0) (0.76, 1.54)
Mild 2899 115 (4.0113 (3.9) (3.32, 4.7) 2908 2119 (0.7) (0.4, 1.10)
Moderate 2899 36 (1.2) (0.9, 1.7) 2908 6 (0.2) (0.1, 0.4)
Severe 2899 7 (0.2) (0.1, 0.5) 2908 3 (0.1) (0.0, 0.3)
Grade 4 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Swellingd
Any 2899 185184 (6.43) (5.5, 7.3) 2908 16 (0.6) (0.3, 0.9)
Mild 2899 124 (4.3) (3.6, 5.1) 2908 6 (0.2) (0.1, 0.4)
Moderate 2899 5554 (1.9) (1.4, 2.54) 2908 8 (0.3) (0.1, 0.5)
Severe 2899 6 (0.2) (0.1, 0.4) 2908 2 (0.1) (0.0, 0.2)
Grade 4 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Pain at the
injection sitee
Any 2900 2899 2428 2426 (83.7) (82.3, 85.10) 2908 418414 (14.42) (13.10, 15.76)
Mild 2900 2899 1464 (50.5) (48.67, 52.3) 2908 395391 (13.64) (12.42, 14.97)
Moderate 2900 2899 924923 (31.98) (30.21, 33.6) 2908 20 (0.7) (0.4, 1.1)
Severe 2900 2899 4039 (1.43) (1.0, 1.98) 2908 3 (0.1) (0.0, 0.3)
Grade 4 2900 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Any local reactionf 2900 2899 2446 2444 (84.3) (83.082.9, 85.6) 2908 438 (15.1 432 (14.9 ) (13.86, 16.42)
2 Rednessd
Any 2683 2682 152151 (5.76) (4.8, 6.6) 2684 18 (0.7) (0.4, 1.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age Group Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 2683 2682 90 (3.4) (2.7, 4.1) 2684 12 (0.4) (0.2, 0.8)
Moderate 2683 2682 5150 (1.9) (1.4, 2.5) 2684 6 (0.2) (0.1, 0.5)
Severe 2683 2682 11 (0.4) (0.2, 0.7) 2684 0 (0.0, 0.1)
Grade 4 2683 2682 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Swellingd
Any 2683 2682 185183 (6.98) (6.05.9, 7.98) 2684 5 (0.2) (0.1, 0.4)
Mild 2683 2682 112110 (4.21) (3.4, 5.04.9) 2684 3 (0.1) (0.0, 0.3)
Moderate 2683 2682 66 (2.5) (1.9, 3.1) 2684 2 (0.1) (0.0, 0.3)
Severe 2683 2682 7 (0.3) (0.1, 0.5) 2684 0 (0.0, 0.1)
Grade 4 2683 2682 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Pain at the
injection sitee
Any 2691 2682 2110 2101 (78.43) (76.8, 80.07, 79.9) 2684 315312 (11.76) (10.5, 13.04, 12.9)
Mild 2691 2682 1280 1274 (47.65) (45.76, 49.54) 2684 287284 (10.76) (9.54, 11.98)
Moderate 2691 2682 791788 (29.4) (27.7, 31.21) 2684 28 (1.0) (0.7, 1.5)
Severe 2691 2682 39 (1.45) (1.0, 2.0) 2684 0 (0.0, 0.1)
Grade 4 2691 2682 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Any local reactionf 2691 2682 2117 2108 (78.76) (77.10, 80.21) 2684 328325 (12.21) (11.010.9, 13.54)
Any
dose Rednessd
Any 2909 278276 (9.65) (8.54, 10.76) 2921 4442 (1.54) (1.0, 1, 2.0.9)
Mild 2909 181180 (6.2) (5.43, 7.21) 2921 29 (1.27 (0.9) (0.76, 1.43)
Moderate 2909 7978 (2.7) (2.21, 3.43) 2921 12 (0.4) (0.2, 0.7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age Group Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Severe 2909 18 (0.6) (0.4, 1.0) 2921 3 (0.1) (0.0, 0.3)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
Swellingd
Any 2909 312309 (10.76) (9.65, 11.98) 2921 20 (0.7) (0.4, 1.1)
Mild 2909 197195 (6.87) (5.98, 7.7) 2921 9 (0.3) (0.1, 0.6)
Moderate 2909 102101 (3.5) (2.98, 4.2) 2921 9 (0.3) (0.1, 0.6)
Severe 2909 13 (0.4) (0.2, 0.8) 2921 2 (0.1) (0.0, 0.2)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
Pain at the
injection sitee
Any 2909 2579 2577 (88.76) (87.4, 89.87) 2921 590585 (20.20) (18.86, 21.75)
Mild 2909 1279 1280 (44.0) (42.2, 45.8) 2921 543538 (18.64) (17.2, 20.0, 19.9)
Moderate 2909 1225 1223 (42.10) (40.32, 43.9) 2921 44 (1.5) (1.1, 2.0)
Severe 2909 7574 (2.65) (2.0, 3.2) 2921 3 (0.1) (0.0, 0.3)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
Any local reactionf 2909 2592 2590 (89.10) (87.98, 90.21) 2921 615 (21.1 609 (20.8 ) (19.64, 22.64)
>55 Years 1 Rednessd
Any 2008 109106 (5.43) (4.53, 6.53) 1989 2120 (1.10) (0.76, 1.65)
Mild 2008 7471 (3.75) (2.98, 4.64) 1989 1413 (0.7) (0.43, 1.21)
Moderate 2008 30 (1.5) (1.0, 2.1) 1989 5 (0.3) (0.1, 0.6)
Severe 2008 5 (0.2) (0.1, 0.6) 1989 2 (0.1) (0.0, 0.4)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
Swellingd
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age Group Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 2008 142141 (7.10) (6.05.9, 8.32) 1989 2523 (1.32) (0.87, 1.87)
Mild 2008 8887 (4.43) (3.5, 5.43) 1989 1311 (0.76) (0.3, 1.10)
Moderate 2008 52 (2.6) (1.9, 3.4) 1989 12 (0.6) (0.3, 1.1)
Severe 2008 2 (0.1) (0.0, 0.4) 1989 0 (0.0, 0.2)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
Pain at the
injection sitee
Any 2008 1409 1408 (70.21) (68.1, 72.21) 1989 187185 (9.43) (8.21, 10.87)
Mild 2008 1109 1108 (55.2) (53.0, 57.4) 1989 179 (177 (8.9.0) (7.87, 10.32)
Moderate 2008 296 (14.7) (13.2, 16.4) 1989 8 (0.4) (0.2, 0.8)
Severe 2008 4 (0.2) (0.1, 0.5) 1989 0 (0.0, 0.2)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
Any local reactionf 2008 1435 1433 (71.54) (69.43, 73.43) 1989 210207 (10.64) (9.2, 12.01, 11.8)
2 Rednessd
Any 1860 134133 (7.2) (6.10, 8.54) 1833 14 (0.8) (0.4, 1.3)
Mild 1860 65 (3.5) (2.7, 4.4) 1833 10 (0.5) (0.3, 1.0)
Moderate 1860 5958 (3.21) (2.4, 4.10) 1833 3 (0.2) (0.0, 0.5)
Severe 1860 10 (0.5) (0.3, 1.0) 1833 1 (0.1) (0.0, 0.3)
Grade 4 1860 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Swellingd
Any 1860 145 (7.8) (6.6, 9.1) 1833 13 (0.7) (0.4, 1.2)
Mild 1860 80 (4.3) (3.4, 5.3) 1833 5 (0.3) (0.1, 0.6)
Moderate 1860 61 (3.3) (2.5, 4.2) 1833 7 (0.4) (0.2, 0.8)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age Group Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Severe 1860 4 (0.2) (0.1, 0.5) 1833 1 (0.1) (0.0, 0.3)
Grade 4 1860 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Pain at the
injection sitee
Any 1863 1860 1236 1230 (66.31) (64.163.9, 68.53) 1835 1833 147 (143 (7.8.0) (6.86, 9.31)
Mild 1863 1860 879 (47.2 873 (46.9 ) (44.96, 49.52) 1835 1833 142138 (7.75) (6.6, 9.14, 8.8)
Moderate 1863 1860 347 (18.67) (16.9, 20.5) 1835 1833 5 (0.3) (0.1, 0.6)
Severe 1863 1860 10 (0.5) (0.3, 1.0) 1835 1833 0 (0.0, 0.2)
Grade 4 1863 1860 0 (0.0, 0.2) 1835 1833 0 (0.0, 0.2)
Any local reactionf 1863 1860 1248 (67.0 1243 (66.8 ) (64.86, 69.10) 1835 1833 162158 (8.86) (7.64, 10.20)
Any
dose Rednessd
Any 2015 213210 (10.64) (9.3, 12.01, 11.8) 1994 3130 (1.65) (1.10, 2.21)
Mild 2015 122120 (6.10) (5.10, 7.21) 1994 2120 (1.10) (0.76, 1.65)
Moderate 2015 7675 (3.87) (3.02.9, 4.76) 1994 8 (0.4) (0.2, 0.8)
Severe 2015 15 (0.7) (0.4, 1.2) 1994 2 (0.1) (0.0, 0.4)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
Swellingd
Any 2015 238237 (11.8) (10.4, 13.32) 1994 3331 (1.76) (1.1, 2.32)
Mild 2015 135134 (6.7) (5.6, 7.98) 1994 1412 (0.76) (0.43, 1.20)
Moderate 2015 97 (4.8) (3.9, 5.8) 1994 18 (0.9) (0.5, 1.4)
Severe 2015 6 (0.3) (0.1, 0.6) 1994 1 (0.1) (0.0, 0.3)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age Group Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 2015 1579 1576 (78.42) (76.53, 80.10) 1994 269264 (13.52) (12.0, 15.111.8, 14.8)
Mild 2015 1079 1076 (53.54) (51.32, 55.76) 1994 256251 (12.86) (11.42, 14.41)
Moderate 2015 486 (24.1) (22.3, 26.0) 1994 13 (0.7) (0.3, 1.1)
Severe 2015 14 (0.7) (0.4, 1.2) 1994 0 (0.0, 0.2)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
Any local reactionf 2015 1599 1597 (79.43) (77.54, 81.10) 1994 300 (15.0 294 (14.7 ) (13.52, 16.74)
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 specified 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 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:24 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s010 lr p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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 5554 2 (3 (5.5.7) (1.1, 15.10.5, 12.7) 56 3 (5.4) (1.1, 14.9)
Mild 5554 2 (3 (5.5.7) (1.1, 15.10.5, 12.7) 56 1 (1.8) (0.0, 9.6)
Moderate 5554 0 (0.0, 6.56) 56 0 (0.0, 6.4)
Severe 5554 0 (0.0, 6.56) 56 2 (3.6) (0.4, 12.3)
Grade 4 5554 0 (0.0, 6.56) 56 0 (0.0, 6.4)
Swellingd
Any 54 3 (5.6) (1.2, 15.4) 56 1 (1.8) (0.0, 9.6)
Mild 54 2 (3.7) (0.5, 12.7) 56 0 (0.0, 6.4)
Moderate 54 1 (1.9) (0.0, 9.9) 56 0 (0.0, 6.4)
Severe 54 0 (0.0, 6.6) 56 1 (1.8) (0.0, 9.6)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
Pain at the injection sitee
Any 5754 38 (66.7 34 (63.0 ) (52.9, 78.648.7, 75.7) 56 9 (16.1) (7.6, 28.3)
Mild 5754 30 (52.6 26 (48.1 ) (39.0, 66.034.3, 62.2) 56 8 (14.3) (6.4, 26.2)
Moderate 5754 8 (14.08) (6.3, 25.86, 27.1) 56 1 (1.8) (0.0, 9.6)
Severe 5754 0 (0.0, 6.36) 56 0 (0.0, 6.4)
Grade 4 5754 0 (0.0, 6.36) 56 0 (0.0, 6.4)
Any local reactionf 5754 39 (68.4 35 (64.8 ) (54.8, 80.150.6, 77.3) 56 10 (17.9) (8.9, 30.4)
2 Rednessd
Any 60 4 (6.7) (1.8, 16.2) 62 1 (1.6) (0.0, 8.7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
Mild 60 3 (5.0) (1.0, 13.9) 62 1 (1.6) (0.0, 8.7)
Moderate 60 1 (1.7) (0.0, 8.9) 62 0 (0.0, 5.8)
Severe 60 0 (0.0, 6.0) 62 0 (0.0, 5.8)
Grade 4 60 0 (0.0, 6.0) 62 0 (0.0, 5.8)
Swellingd
Any 60 5 (8.3) (2.8, 18.4) 62 0 (0.0, 5.8)
Mild 60 2 (3.3) (0.4, 11.5) 62 0 (0.0, 5.8)
Moderate 60 3 (5.0) (1.0, 13.9) 62 0 (0.0, 5.8)
Severe 60 0 (0.0, 6.0) 62 0 (0.0, 5.8)
Grade 4 60 0 (0.0, 6.0) 62 0 (0.0, 5.8)
Pain at the injection sitee
Any 6160 33 (54.1 32 (53.3 ) (40.80, 66.93) 62 5 (8.1) (2.7, 17.8)
Mild 6160 23 (3722 (36.7) (2524.6, 51.050.1) 62 5 (8.1) (2.7, 17.8)
Moderate 6160 9 (14.815.0) (7.01, 26.26) 62 0 (0.0, 5.8)
Severe 6160 1 (1.67) (0.0, 8.89) 62 0 (0.0, 5.8)
Grade 4 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
Any local reactionf 6160 33 (54.1 32 (53.3 ) (40.80, 66.93) 62 5 (8.1) (2.7, 17.8)
Any dose Rednessd
Any 7372 5 (6 (8.2.9) (2.3.1, 17.0, 15.5) 74 3 (4.1) (0.8, 11.4)
Mild 7372 4 (5 (.6.8) (2.3, 15.31.5, 13.6) 74 1 (1.4) (0.0, 7.3)
Moderate 7372 1 (1.4) (0.0, 7.45) 74 0 (0.0, 4.9)
Severe 7372 0 (0.0, 4.95.0) 74 2 (2.7) (0.3, 9.4)
Grade 4 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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 72 7 (9.7) (4.0, 19.0) 74 1 (1.4) (0.0, 7.3)
Mild 72 4 (5.6) (1.5, 13.6) 74 0 (0.0, 4.9)
Moderate 72 3 (4.2) (0.9, 11.7) 74 0 (0.0, 4.9)
Severe 72 0 (0.0, 5.0) 74 1 (1.4) (0.0, 7.3)
Grade 4 72 0 (0.0, 5.0) 74 0 (0.0, 4.9)
Pain at the injection sitee
Any 7472 54 (73.0 49 (68.1 ) (61.4, 8256.0, 78.6) 74 12 (16.2) (8.7, 26.6)
Mild 7472 40 (54.1 35 (48.6 ) (42.1, 6536.7, 60.7) 74 11 (14.9) (7.7, 25.0)
Moderate 7472 13 (17.618.1) (9.710.0, 28.29) 74 1 (1.4) (0.0, 7.3)
Severe 7472 1 (1.4) (0.0, 7.35) 74 0 (0.0, 4.9)
Grade 4 7472 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
Any local reactionf 7472 54 (73.0 49 (68.1 ) (61.4, 8256.0, 78.6) 74 13 (17.6) (9.7, 28.2)
Abbreviation: HIV = human immunodeficiency virus.
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 specified 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 exfoliative dermatitis
(redness category 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 sever e 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 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:2427MAR2021 (01:55 )
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s010 lr hiv p3 saf
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Positive 1 Rednessd
Any 177 9 (5.1) (2.4, 9.4) 187 5 (2.7) (0.9, 6.1)
Mild 177 3 (1.7) (0.4, 4.9) 187 2 (1.1) (0.1, 3.8)
Moderate 177 4 (2.3) (0.6, 5.7) 187 1 (0.5) (0.0, 2.9)
Severe 177 2 (1.1) (0.1, 4.0) 187 2 (1.1) (0.1, 3.8)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Swellingd
Any 177 14 (7.9) (4.4, 12.9) 187 1 (0.5) (0.0, 2.9)
Mild 177 5 (2.8) (0.9, 6.5) 187 0 (0.0, 2.0)
Moderate 177 8 (4.5) (2.0, 8.7) 187 0 (0.0, 2.0)
Severe 177 1 (0.6) (0.0, 3.1) 187 1 (0.5) (0.0, 2.9)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 177 129 (72.9) (65.7, 79.3) 187 25 (13.4) (8.8, 19.1)
Mild 177 71 (40.1) (32.8, 47.7) 187 21 (11.2) (7.1, 16.7)
Moderate 177 54 (30.5) (23.8, 37.9) 187 3 (1.6) (0.3, 4.6)
Severe 177 4 (2.3) (0.6, 5.7) 187 1 (0.5) (0.0, 2.9)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Any local
reactionf 177 133 (75.1) (68.1, 81.3) 187 27 (14.4) (9.7, 20.3)
2 Rednessd
Any 153 6 (3.9) (1.5, 8.3) 165 1 (0.6) (0.0, 3.3)
Mild 153 5 (3.3) (1.1, 7.5) 165 0 (0.0, 2.2)
Moderate 153 1 (0.7) (0.0, 3.6) 165 0 (0.0, 2.2)
Severe 153 0 (0.0, 2.4) 165 1 (0.6) (0.0, 3.3)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Swellingd
Any 153 8 (5.2) (2.3, 10.0) 165 1 (0.6) (0.0, 3.3)
Mild 153 3 (2.0) (0.4, 5.6) 165 1 (0.6) (0.0, 3.3)
Moderate 153 5 (3.3) (1.1, 7.5) 165 0 (0.0, 2.2)
Severe 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 154153 94 (61.0 93 (60.8 ) (52.96, 68.86) 165 11 (6.7) (3.4, 11.6)
Mild 154153 54 (35.1 53 (34.6 ) (27.6, 43.21, 42.7) 165 9 (5.5) (2.5, 10.1)
Moderate 154153 34 (22.12) (15.89, 29.56) 165 2 (1.2) (0.1, 4.3)
Severe 154153 6 (3.9) (1.45, 8.3) 165 0 (0.0, 2.2)
Grade 4 154153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Any local
reactionf 154153 9695 (62.31) (54.2, 70.053.9, 69.8) 165 12 (7.3) (3.8, 12.4)
Any
dose Rednessd
Any 177 15 (8.5) (4.8, 13.6) 187 5 (2.7) (0.9, 6.1)
Mild 177 8 (4.5) (2.0, 8.7) 187 2 (1.1) (0.1, 3.8)
Moderate 177 5 (2.8) (0.9, 6.5) 187 1 (0.5) (0.0, 2.9)
Severe 177 2 (1.1) (0.1, 4.0) 187 2 (1.1) (0.1, 3.8)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Swellingd
Any 177 18 (10.2) (6.1, 15.6) 187 2 (1.1) (0.1, 3.8)
Mild 177 6 (3.4) (1.3, 7.2) 187 1 (0.5) (0.0, 2.9)
Moderate 177 11 (6.2) (3.1, 10.8) 187 0 (0.0, 2.0)
Severe 177 1 (0.6) (0.0, 3.1) 187 1 (0.5) (0.0, 2.9)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 177 142 (80.2) (73.6, 85.8) 187 31 (16.6) (11.6, 22.7)
Mild 177 70 (39.5) (32.3, 47.2) 187 25 (13.4) (8.8, 19.1)
Moderate 177 62 (35.0) (28.0, 42.5) 187 5 (2.7) (0.9, 6.1)
Severe 177 10 (5.6) (2.7, 10.1) 187 1 (0.5) (0.0, 2.9)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Any local
reactionf 177 145 (81.9) (75.4, 87.3) 187 33 (17.6) (12.5, 23.9)
Negative 1 Rednessd
Any 4701 255250 (5.43) (4.87, 6.10) 4690 46 (1.43 (0.9) (0.7, 1.32)
Mild 4701 183178 (3.98) (3.3, 4, .4.5) 4690 3330 (0.76) (0.5, 1.4, 0.9)
Moderate 4701 62 (1.3) (1.0, 1.7) 4690 10 (0.2) (0.1, 0.4)
Severe 4701 10 (0.2) (0.1, 0.4) 4690 3 (0.1) (0.0, 0.2)
Grade 4 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Swellingd
Any 4701 310308 (6.6) (5.9, 7.3) 4690 4038 (0.98) (0.6, 1.21)
Mild 4701 204203 (4.3) (3.8, 5.04.9) 4690 1917 (0.4) (0.2, 0.6)
Moderate 4701 9998 (2.1) (1.7, 2.65) 4690 20 (0.4) (0.3, 0.7)
Severe 4701 7 (0.1) (0.1, 0.3) 4690 1 (0.0) (0.0, 0.1)
Grade 4 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 4702 4701 3685 3682 (78.43) (77.21, 79.5) 4690 579573 (12.32) (11.43, 13.32)
Mild 4702 4701 2487 2486 (52.9) (51.54, 54.3) 4690 552546 (11.86) (10.97, 12.76)
Moderate 4702 4701 1159 1158 (24.6) (23.4, 25.9) 4690 25 (0.5) (0.3, 0.8)
Severe 4702 4701 3938 (0.8) (0.6, 1.1) 4690 2 (0.0) (0.0, 0.2)
Grade 4 4702 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Any local
reactionf 4702 4701 3725 3721 (79.2) (78.0, 80.43) 4690 620611 (13.20) (12.31, 14.20)
2 Rednessd
Any 4369 4368 279277 (6.43) (5.6, 7, 7.2.1) 4334 31 (0.7) (0.5, 1.0)
Mild 4369 4368 149 (3.4) (2.9, 4.0) 4334 22 (0.5) (0.3, 0.8)
Moderate 4369 4368 109107 (2.54) (2.10, 3.0) 4334 9 (0.2) (0.1, 0.4)
Severe 4369 4368 21 (0.5) (0.3, 0.7) 4334 0 (0.0, 0.1)
Grade 4 4369 4368 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
Swellingd
Any 4369 4368 320318 (7.3) (6.65, 8.1) 4334 17 (0.4) (0.2, 0.6)
Mild 4369 4368 187185 (4.32) (3.7, 4.9) 4334 7 (0.2) (0.1, 0.3)
Moderate 4369 4368 122 (2.8) (2.3, 3.3) 4334 9 (0.2) (0.1, 0.4)
Severe 4369 4368 11 (0.3) (0.1, 0.5) 4334 1 (0.0) (0.0, 0.1)
Grade 4 4369 4368 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 4379 4368 3238 3224 (73.98) (72.65, 75.21) 4336 4334 450443 (10.42) (9.53, 11.32)
Mild 4379 4368 2096 2085 (47.97) (46.42, 49.42) 4336 4334 419412 (9.75) (8.86, 10.64)
Moderate 4379 4368 1099 1096 (25.1) (23.8, 26.4) 4336 4334 31 (0.7) (0.5, 1.0)
Severe 4379 4368 43 (1.0) (0.7, 1.3) 4336 4334 0 (0.0, 0.1)
Grade 4 4379 4368 0 (0.0, 0.1) 4336 4334 0 (0.0, 0.1)
Any local
reactionf 4379 4368 3255 3242 (74.32) (73.072.9, 75.65) 4336 4334 477 (11.0 470 (10.8 ) (10.1, 12.09.9, 11.8)
Any
dose Rednessd
Any 4718 472 (10.0 467 (9.9) (9.21, 10.98) 4708 7067 (1.54) (1.2, 1.9, 1.8)
Mild 4718 291288 (6.21) (5.54, 6.98) 4708 4845 (1.0) (0.87, 1.3)
Moderate 4718 150148 (3.21) (2.7, 3.7) 4708 19 (0.4) (0.2, 0.6)
Severe 4718 31 (0.7) (0.4, 0.9) 4708 3 (0.1) (0.0, 0.2)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
Swellingd
Any 4718 527523 (11.21) (10.32, 12.10) 4708 5149 (1.10) (0.8, 1.4)
Mild 4718 321318 (6.87) (6.10, 7.65) 4708 2220 (0.54) (0.3, 0.7)
Moderate 4718 188187 (4.0) (3.4, 4.6) 4708 27 (0.6) (0.4, 0.8)
Severe 4718 18 (0.4) (0.2, 0.6) 4708 2 (0.0) (0.0, 0.2)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Pain at the
injection sitee
Any 4718 3992 3987 (84.65) (83.64, 85.65) 4708 826816 (17.53) (16.53, 18.74)
Mild 4718 2275 2273 (48.2) (46.87, 49.76) 4708 772762 (16.42) (15.41, 17.53)
Moderate 4718 1639 1637 (34.7) (33.43, 36.1) 4708 52 (1.1) (0.8, 1.4)
Severe 4718 7877 (1.76) (1.3, 2.10) 4708 2 (0.0) (0.0, 0.2)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
Any local
reactionf 4718 4022 4018 (85.2) (84.21, 86.2) 4708 880868 (18.74) (17.63, 19.86)
Abbreviation: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
Note: Subjects whose baseline SARS -CoV -2 status cannot be determined because of missing N -binding antibody or NAAT at Visit 1 were not included in
the analysis.
Note: Positive = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. Negative = negative N -
binding antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID -19.
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 medi cally 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 specified 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 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:24 27MAR2021 (01:55 )
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -CoV- 2
Status Dose Local Reaction Na nb (%) (95% CIc) Na nb (%) (95% CIc)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s010 lr base p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
16-55 Years 1 Redness
na 158156 3028
Mean (SD) 2.32 (1.9992) 1.7 (1. 3539)
Median 1.50 1.0
Min, max (1, 14) (1, 6)
Swelling
na 185184 16
Mean (SD) 2.0 (1.55) 2.2 (2.46)
Median 1.0 1.0
Min, max (1, 12) (1, 10)
Pain at the injection site
na 2428 2426 418414
Mean (SD) 2.2 (1.49) 1.56 (1.5051)
Median 2.0 1.0
Min, max (1, 22) (1, 17)
Unknownb 2 1
2 Redness
na 152151 18
Mean (SD) 2.2 (1.60) 1.2 (0.43)
Median 2.0 1.0
Min, max (1, 9) (1, 2)
Swelling
na 185183 5
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
Mean (SD) 2.1 (1. 4950) 2.2 (0.84)
Median 2.0 2.0
Min, max (1, 8) (1, 3)
Pain at the injection site
na 2110 2101 315312
Mean (SD) 2.5 (2. 2021) 1.9 (2. 8284)
Median 2.0 1.0
Min, max (1, 70) (1, 35)
Unknownb 5 0
>55 Years 1 Redness
na 109106 2120
Mean (SD) 2.43 (2.3633) 1.9 (2. 0610)
Median 2.0 1.0
Min, max (1, 20) (1, 10)
Swelling
na 142141 2523
Mean (SD) 1.78 (1.0304) 2.86 (2.8450)
Median 1.0 1.0
Min, max (1, 6) (1, 11)
Pain at the injection site
na 1409 1408 187185
Mean (SD) 1.9 (1.46) 1.8 (2. 1516)
Median 2.0 1.0
Min, max (1, 22) (1, 19)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
2 Redness
na 134133 14
Mean (SD) 3.0 (3. 9192) 1.6 (1.65)
Median 2.0 1.0
Min, max (1, 34) (1, 7)
Unknownb 3 0
Swelling
na 145 13
Mean (SD) 2.6 (3.21) 1.8 (1. 2830)
Median 2.0 1.0
Min, max (1, 34) (1, 5)
Pain at the injection site
na 1236 1230 147143
Mean (SD) 2.4 (1. 9899) 1.9 (2.65 7 (1.25 )
Median 2.0 1.0
Min, max (1, 36) (1, 307)
Unknownb 3 1
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 subject s reporting the specified reaction on any of the 7 days, including subjects with reactions of unknown duration.
b. Includes those reactions where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:0625MAR2021 (19:19) Source Data: adcevd Table Generation: 29APR2021
(23:34 27MAR2021 (01:29 )
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unblinded/C4591001_ sBLA CBER EDIARY BLA /adce_s030_lr_dur_p3_saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Local Reactions (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
1 Redness
na 32 3
Mean (SD) 1.75 (0.5871) 1.0 (0.00)
Median 2.01.5 1.0
Min, max (1, 2) (1, 1)
Swelling
na 3 1
Mean (SD) 1.3 (0.58) 1.0 (NE)
Median 1.0 1.0
Min, max (1, 2) (1, 1)
Pain at the injection site
na 3834 9
Mean (SD) 2.0 (1. 1421) 1.9 (1.36)
Median 2.0 1.0
Min, max (1, 7) (1, 5)
2 Redness
na 4 1
Mean (SD) 1.3 (0.50) 2.0 (NE)
Median 1.0 2.0
Min, max (1, 2) (2, 2)
Swelling
na 5 0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Local Reactions (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
Mean (SD) 1.8 (0.84) NE (NE)
Median 2.0 NE
Min, max (1, 3) (NE, NE)
Pain at the injection site
na 3332 5
Mean (SD) 1.98 (1.1704) 2.0 (1.41)
Median 1.0 1.0
Min, max (1, 54) (1, 4)
Abbreviations: HIV = human immunodeficiency virus; 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.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:0625MAR2021 (19:19) Source Data: adcevd Table Generation: 29APR2021
(23:34 27MAR2021 (01:29)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s030 lr dur hiv p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
16-55 Years 1 Redness
na 158156 3028
Mean (SD) 2.3 (0.98) 1.89 (1.2730)
Median 2.0 1.0
Min, max (1, 7) (1, 5)
Swelling
na 185184 16
Mean (SD) 2.0 (0.80) 1.8 (1.29)
Median 2.0 1.0
Min, max (1, 5) (1, 5)
Pain at the injection site
na 2428 2426 418414
Mean (SD) 1.4 (0.55) 1.6 (1. 1516)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
Any local reactionb
na 2446 2444 438432
Mean (SD) 1.4 (0.55) 1.6 (1.14)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
2 Redness
na 152151 18
Mean (SD) 2.5 (0. 9897) 2.2 (1.50)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
Median 2.0 2.0
Min, max (1, 6) (1, 6)
Swelling
na 185183 5
Mean (SD) 2.0 (0.86) 2.0 (1.00)
Median 2.0 2.0
Min, max (1, 5) (1, 3)
Pain at the injection site
na 2110 2101 315312
Mean (SD) 1.4 (0.59) 1.45 (0.9596)
Median 1.0 1.0
Min, max (1, 6) (1, 7)
Any local reactionb
na 2117 2108 328325
Mean (SD) 1.4 (0.59) 1.5 (1.01)
Median 1.0 1.0
Min, max (1, 6) (1, 7)
>55 Years 1 Redness
na 109106 2120
Mean (SD) 2.3 (0. 8281) 1.6 (0. 5150)
Median 2.0 2.0
Min, max (1, 5) (1, 2)
Swelling
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
na 142141 2523
Mean (SD) 1.9 (0. 5857) 1.54 (0.8773)
Median 2.0 1.0
Min, max (1, 4) (1, 4)
Pain at the injection site
na 1409 1408 187185
Mean (SD) 1.6 (0.53) 1.8 (1.20)
Median 2.0 1.0
Min, max (1, 5) (1, 7)
Any local reactionb
na 1435 1433 210207
Mean (SD) 1.6 (0.53) 1.8 (1. 1415)
Median 2.0 1.0
Min, max (1, 5) (1, 7)
2 Redness
na 134133 14
Mean (SD) 2.78 (1.0403) 2.0 (1.30)
Median 3.0 2.0
Min, max (1, 5) (1, 6)
Swelling
na 145 13
Mean (SD) 2.1 (0.83) 1.7 (1.18)
Median 2.0 1.0
Min, max (1, 5) (1, 5)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Local Reactions, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Local Reaction BNT162b2 (30 μg) Placebo
Pain at the injection site
na 1236 1230 147143
Mean (SD) 1.56 (0.68) 1.7 (1. 1819)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
Any local reactionb
na 1248 1243 162158
Mean (SD) 1.56 (0.6667) 1.7 (1. 2122)
Median 1.0 1.0
Min, max (1, 6) (1, 7)
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 cm, or any pain at the injection site.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:22 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unbl inded/C4591001_ sBLA CBER EDIARY BLA /adce_s050_lr_onset_p3_saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Local Reactions (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
1 Redness
na 32 3
Mean (SD) 1.7 (2.0.58 (0.00 ) 1.0 (0.00)
Median 2.0 1.0
Min, max (12, 2) (1, 1)
Swelling
na 3 1
Mean (SD) 2.0 (0.00) 2.0 (NE)
Median 2.0 2.0
Min, max (2, 2) (2, 2)
Pain at the injection site
na 3834 9
Mean (SD) 1.4 (0.50) 2.6 (1.24)
Median 1.0 2.0
Min, max (1, 2) (1, 5)
Any local reactionb
na 3935 10
Mean (SD) 1.4 (0.50) 1.9 (0.99)
Median 1.0 2.0
Min, max (1, 2) (1, 4)
2 Redness
na 4 1
Mean (SD) 2.0 (0.82) 1.0 (NE)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Local Reactions (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
Median 2.0 1.0
Min, max (1, 3) (1, 1)
Swelling
na 5 0
Mean (SD) 1.4 (0.55) NE (NE)
Median 1.0 NE
Min, max (1, 2) (NE, NE)
Pain at the injection site
na 3332 5
Mean (SD) 1.56 (0.67) 1.6 (0.89)
Median 1.05 1.0
Min, max (1, 3) (1, 3)
Any local reactionb
na 3332 5
Mean (SD) 1.56 (0.67) 1.6 (0.89)
Median 1.0 1.0
Min, max (1, 3) (1, 3)
Abbreviations: HIV = human immunodeficiency virus; 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 cm, or any pain at the injection site.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:22 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unbl inded/C4591001 sBLA CBER EDIARY BLA /adce s050 lr onset hiv p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
16-55
Years 1 Fever
≥38.0°C Any 2899 119120 (4.1) (3.4, 4.9) 2908 25 (0.9) (0.6, 1.3)
≥38.0°C to 38.4°C 2899 86 (3.0) (2.4, 3.7) 2908 16 (0.6) (0.3, 0.9)
>38.4°C to 38.9°C 2899 25 (0.9) (0.6, 1.3) 2908 5 (0.2) (0.1, 0.4)
>38.9°C to 40.0°C 2899 8 (0.3) (0.1, 0.5) 2908 4 (0.1) (0.0, 0.4)
>40.0°C 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Unknownd 2899 1 (0.0) (0.0, 0.2) 2908 0 (0.0, 0.1)
FatiguedFatiguee
Any 2899 2900 1431 1433 (49.4) (47.56, 51.23) 2908 960 (33.0) (31.3, 34.8)
Mild 2899 2900 760762 (26.23) (24.67, 27.9) 2908 570 (19.6) (18.2, 21.1)
Moderate 2899 2900 630 (21.7) (20.2, 23.3) 2908 372 (12.8) (11.6, 14.1)
Severe 2899 2900 41 (1.4) (1.0, 1.9) 2908 18 (0.6) (0.4, 1.0)
Grade 4 2899 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
HeadachedHeadachee
Any 2899 2901 1262 1264 (43.56
) (41.78, 45.4) 2908 2909 975976 (33.56) (31.8, 35.3)
Mild 2899 2901 785787 (27.1) (25.5, 28.78) 2908 2909 633 (21.8) (20.3, 23.3)
Moderate 2899 2901 444 (15.3) (14.0, 16.7) 2908 2909 318 (10.9 319 (1
1.0) (9.89, 12.12)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Severe 2899 2901 33 (1.1) (0.8, 1.6) 2908 2909 24 (0.8) (0.5, 1.2)
Grade 4 2899 2901 0 (0.0, 0.1) 2908 2909 0 (0.0, 0.1)
ChillsdChillse
Any 2899 2900 479481 (16.56) (15.2, 17.918.0) 2908 199200 (6.89) (6.0, 7.89)
Mild 2899 2900 338 (11.7) (10.5, 12.9) 2908 148149 (5.1) (4.34, 6.0)
Moderate 2899 2900 126128 (4.34) (3.67, 5.2) 2908 49 (1.7) (1.2, 2.2)
Severe 2899 2900 15 (0.5) (0.3, 0.9) 2908 2 (0.1) (0.0, 0.2)
Grade 4 2899 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
VomitingeVomitingf
Any 2899 34 (1.2) (0.8, 1.6) 2908 36 (1.2) (0.9, 1.7)
Mild 2899 29 (1.0) (0.7, 1.4) 2908 30 (1.0) (0.7, 1.5)
Moderate 2899 5 (0.2) (0.1, 0.4) 2908 5 (0.2) (0.1, 0.4)
Severe 2899 0 (0.0, 0.1) 2908 1 (0.0) (0.0, 0.2)
Grade 4 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
DiarrheafDiarrheag
Any 2899 309 (10.7) (9.6, 11.8) 2908 323324 (11.1) (10.0, 12.3)
Mild 2899 251 (8.7) (7.7, 9.7) 2908 264265 (9.1) (8.1, 10.2)
Moderate 2899 55 (1.9) (1.4, 2.5) 2908 58 (2.0) (1.5, 2.6)
Severe 2899 3 (0.1) (0.0, 0.3) 2908 1 (0.0) (0.0, 0.2)
Grade 4 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
New or worsened
muscle paindpaine
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 2899 2900 664 (22.9 667 (2
3.0) (21.45, 24.56) 2908 329 (11.3) (10.2, 12.5)
Mild 2899 2900 353355 (12.2) (11.01, 13.45) 2908 231 (7.9) (7.0, 9.0)
Moderate 2899 2900 296297 (10.2) (9.12, 11.4) 2908 96 (3.3) (2.7, 4.0)
Severe 2899 2900 15 (0.5) (0.3, 0.9) 2908 2 (0.1) (0.0, 0.2)
Grade 4 2899 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
New or worsened joint
paindpaine
Any 2899 342 (11.8) (10.6, 13.0) 2908 168 (5.8) (5.0, 6.7)
Mild 2899 200 (6.9) (6.0, 7.9) 2908 112 (3.9) (3.2, 4.6)
Moderate 2899 137 (4.7) (4.0, 5.6) 2908 55 (1.9) (1.4, 2.5)
Severe 2899 5 (0.2) (0.1, 0.4) 2908 1 (0.0) (0.0, 0.2)
Grade 4 2899 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Any systemic
eventgeventh 2899 2901 1979 1983 (68.34
) (66.56, 70.0) 2908 2909 1559 1560 (53.6) (51.8, 55.45)
Use of antipyretic or
pain
medicationhmedicationi 2899 805 (27.8) (26.1, 29.4) 2908 398 (13.7) (12.5, 15.0)
2 Fever
≥38.0°C Any 2682 2691 440456 (16.49) (15.0, 17.95, 18.4) 2684 2685 1113 (0.45) (0.23, 0.78)
≥38.0°C to 38.4°C 2682 2691 254 (9.54) (8.4, 10.6) 2684 2685 5 (0.2) (0.1, 0.4)
>38.4°C to 38.9°C 2682 2691 146 (5.4) (4.6, 6.43) 2684 2685 4 (0.1) (0.0, 0.4)
>38.9°C to 40.0°C 2682 2691 39 (1.54) (1.0, 2.0) 2684 2685 2 (0.1) (0.0, 0.3)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
>40.0°C 2682 2691 1 (0.0) (0.0, 0.2) 2684 2685 0 (0.0, 0.1)
Unknownd 2691 16 (0.6) (0.3, 1.0) 2685 2 (0.1) (0.0, 0.3)
FatiguedFatiguee
Any 2682 2690 1649 1659 (61.57
) (59.68, 63.35) 2684 614 (22.9 617 (2
3.0) (21.34, 24.56)
Mild 2682 2690 558563 (20.89) (19.34, 22.45) 2684 317320 (11.89) (10.67, 13.12)
Moderate 2682 2690 949952 (35.4) (33.6, 37.2) 2684 283 (10.5) (9.4, 11.8)
Severe 2682 2690 142144 (5.34) (4.5, 6.23) 2684 14 (0.5) (0.3, 0.9)
Grade 4 2682 2690 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Headached Headachee
Any 2682 2688 1448 (54.0)
1456 (54.2) (52.1, 55.9)
(52.3, 56.1) 2684 2686 652 (24.3)
657 (24.5) (22.7, 26.0)
(22.8, 26.1)
Mild 2682 2688 699 (26.1)
704 (26.2) (24.4, 27.8)
(24.5, 27.9) 2684 2686 404 (15.1)
409 (15.2) (13.7, 16.5)
(13.9, 16.6)
Moderate 2682 2688 658 (24.5)
660 (24.6) (22.9, 26.2)
(22.9, 26.2) 2684 2686 230 (8.6) (7.5, 9.7)
Severe 2682 2688 91 (3.4) 92 (3.4) (2.7, 4.1) (2.8, 4.2) 2684 2686 18 (0.7) (0.4, 1.1)
Grade 4 2682 2688 0 (0.0, 0.1) 2684 2686 0 (0.0, 0.1)
Chillsd Chillse
Any 2682 2688 1015 (37.8)
1024 (38.1) (36.0, 39.7) 2684 114 (4.2)
115 (4.3) (3.5, 5.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 2682 2688 477 (17.8)
482 (17.9) (16.4, 19.3) 2684 89 (3.3) 90 (3.4) (2.7, 4.1)
Moderate 2682 2688 469 (17.5)
473 (17.6) (16.1, 19.0) 2684 23 (0.9) (0.5, 1.3)
Severe 2682 2688 69 (2.6) 69 (2.6) (2.0, 3.2) 2684 2 (0.1) (0.0, 0.3)
Grade 4 2682 2688 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Vomitinge Vomitingf
Any 2682 58 (2.2) (1.6, 2.8) 2684 30 (1.1) (0.8, 1.6)
Mild 2682 42 (1.6) (1.1, 2.1) 2684 20 (0.7) (0.5, 1.1)
Moderate 2682 12 (0.4) (0.2, 0.8) 2684 10 (0.4) (0.2, 0.7)
Severe 2682 4 (0.1) (0.0, 0.4) 2684 0 (0.0, 0.1)
Grade 4 2682 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
DiarrheafDiarrheag
Any 2682 269 (10.0) (8.9, 11.2) 2684 2685 205206 (7.67) (6.7, 8.7)
Mild 2682 219 (8.2) (7.2, 9.3) 2684 2685 169170 (6.3) (5.4, 7.3)
Moderate 2682 44 (1.6) (1.2, 2.2) 2684 2685 35 (1.3) (0.9, 1.8)
Severe 2682 6 (0.2) (0.1, 0.5) 2684 2685 1 (0.0) (0.0, 0.2)
Grade 4 2682 0 (0.0, 0.1) 2684 2685 0 (0.0, 0.1)
New or worsened
muscle paindpaine
Any 2682 2692 1055 1069 (39.37
) (37.59, 41.26) 2684 237 (8.8) (7.8, 10.0)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 2682 2692 441450 (16.47) (15.1, 17.93, 18.2) 2684 150 (5.6) (4.7, 6.5)
Moderate 2682 2692 552557 (20.67) (19.12, 22.23) 2684 84 (3.1) (2.5, 3.9)
Severe 2682 2692 62 (2.3) (1.8, 3.02.9) 2684 3 (0.1) (0.0, 0.3)
Grade 4 2682 2692 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
New or worsened joint
paindpaine
Any 2682 2684 638 (23.8 643 (2
4.0) (22.24, 25.46) 2684 147 (5.5) (4.6, 6.4)
Mild 2682 2684 291293 (10.9) (9.78, 12.12) 2684 82 (3.1) (2.4, 3.8)
Moderate 2682 2684 320 (11.9 323 (1
2.0) (10.78, 13.23) 2684 61 (2.3) (1.7, 2.9)
Severe 2682 2684 27 (1.0) (0.7, 1.5) 2684 4 (0.1) (0.0, 0.4)
Grade 4 2682 2684 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Any systemic
eventgeventh 2682 2702 2034 (75.8 2057
(76.1 ) (74.25, 77.47) 2684 2687 1026 1032 (38.24
) (36.46, 40.13)
Use of antipyretic or
pain
medicationhmedicationi 2682 1213 (45.2) (43.3, 47.1) 2684 320 (11.9) (10.7, 13.2)
Any
dose Fever
≥38.0°C Any 2909 517 (17.8 533 (1
8.3) (16.49, 19.28) 2921 2922 3436 (1.2) (0.89, 1.67)
≥38.0°C to 38.4°C 2909 310 (10.7) (9.6, 11.8) 2921 2922 20 (0.7) (0.4, 1.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
>38.4°C to 38.9°C 2909 163 (5.6) (4.8, 6.5) 2921 2922 9 (0.3) (0.1, 0.6)
>38.9°C to 40.0°C 2909 43 (1.5) (1.1, 2.0) 2921 2922 5 (0.2) (0.1, 0.4)
>40.0°C 2909 1 (0.0) (0.0, 0.2) 2921 2922 0 (0.0, 0.1)
Unknownd 2909 16 (0.6) (0.3, 0.9) 2922 2 (0.1) (0.0, 0.2)
FatiguedFatiguee
Any 2909 2038 2042 (70.12
) (68.45, 71.79) 2921 1172 (40.1) (38.3, 41.9)
Mild 2909 672673 (23.1) (21.6, 24.7) 2921 615 (21.1) (19.6, 22.6)
Moderate 2909 1191 (40.9 1192
(41.0 ) (39.12, 42.8) 2921 529 (18.1) (16.7, 19.6)
Severe 2909 175177 (6.01) (5.2, 6.97.0) 2921 28 (1.0) (0.6, 1.4)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
HeadachedHeadachee
Any 2909 1889 (64.9 1893
(65.1 ) (63.23, 66.78) 2921 2922 1225 (41.9 1229
(42.1 ) (40.13, 43.89)
Mild 2909 870 (29.9 873 (3
0.0) (28.23, 31.67) 2921 2922 730733 (25.01) (23.45, 26.67)
Moderate 2909 901 (31.0) (29.3, 32.7) 2921 2922 454455 (15.56) (14.23, 16.9)
Severe 2909 118119 (4.1) (3.4, 4.89) 2921 2922 41 (1.4) (1.0, 1.9)
Grade 4 2909 0 (0.0, 0.1) 2921 2922 0 (0.0, 0.1)
ChillsdChillse
Any 2909 1208 1215 (41.58
) (39.740.0, 43.36) 2921 270272 (9.23) (8.23, 10.4)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 2909 594598 (20.46) (19.0, 21.91, 22.1) 2921 205207 (7.01) (6.12, 8.01)
Moderate 2909 532535 (18.34) (16.917.0, 19.78) 2921 61 (2.1) (1.6, 2.7)
Severe 2909 82 (2.8) (2.2, 3.5) 2921 4 (0.1) (0.0, 0.4)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
VomitingeVomitingf
Any 2909 87 (3.0) (2.4, 3.7) 2921 60 (2.1) (1.6, 2.6)
Mild 2909 67 (2.3) (1.8, 2.9) 2921 44 (1.5) (1.1, 2.0)
Moderate 2909 16 (0.6) (0.3, 0.9) 2921 15 (0.5) (0.3, 0.8)
Severe 2909 4 (0.1) (0.0, 0.4) 2921 1 (0.0) (0.0, 0.2)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
DiarrheafDiarrheag
Any 2909 492 (16.9) (15.6, 18.3) 2921 460462 (15.78) (14.45, 17.12)
Mild 2909 393 (13.5) (12.3, 14.8) 2921 369371 (12.67) (11.4, 13.95, 14.0)
Moderate 2909 90 (3.1) (2.5, 3.8) 2921 89 (3.0) (2.5, 3.7)
Severe 2909 9 (0.3) (0.1, 0.6) 2921 2 (0.1) (0.0, 0.2)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
New or worsened
muscle paindpaine
Any 2909 1325 1335 (45.59
) (43.744.1, 47.47) 2921 471 (16.1) (14.8, 17.5)
Mild 2909 530534 (18.24) (16.817.0, 19.78) 2921 304 (10.4) (9.3, 11.6)
Moderate 2909 721 (24.8 727 (2
5.0) (23.24, 26.46) 2921 162 (5.5) (4.7, 6.4)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Severe 2909 74 (2.5) (2.0, 3.2) 2921 5 (0.2) (0.1, 0.4)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
New or worsened joint
paindpaine
Any 2909 799804 (27.56) (25.926.0, 29.13) 2921 272 (9.3) (8.3, 10.4)
Mild 2909 359361 (12.34) (11.2, 13.67) 2921 161 (5.5) (4.7, 6.4)
Moderate 2909 408411 (14.01) (12.89, 15.34) 2921 106 (3.6) (3.0, 4.4)
Severe 2909 32 (1.1) (0.8, 1.5) 2921 5 (0.2) (0.1, 0.4)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
Any systemic
eventgeventh 2909 2446 2451 (84.13
) (82.79, 85.46) 2921 2922 1797 1798 (61.5) (59.7, 63.3)
Use of antipyretic or
pain
medicationhmedicationi 2909 1485 (51.0) (49.2, 52.9) 2921 605 (20.7) (19.3, 22.2)
>55
Years 1 Fever
≥38.0°C Any 2008 2627 (1.3) (0.8, 1.9, 2.0) 1989 89 (0.45) (0.2, 0.89)
≥38.0°C to 38.4°C 2008 23 (1.1) (0.7, 1.7) 1989 3 (0.2) (0.0, 0.4)
>38.4°C to 38.9°C 2008 2 (0.1) (0.0, 0.4) 1989 3 (0.2) (0.0, 0.4)
>38.9°C to 40.0°C 2008 1 (0.0) (0.0, 0.3) 1989 2 (0.1) (0.0, 0.4)
>40.0°C 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
Unknownd 2008 1 (0.0) (0.0, 0.3) 1989 1 (0.1) (0.0, 0.3)
Fatigued Fatiguee
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 2008 677 (33.7) (31.6, 35.8) 1989 447 (22.5) (20.7, 24.4)
Mild 2008 415 (20.7) (18.9, 22.5) 1989 281 (14.1) (12.6, 15.7)
Moderate 2008 259 (12.9) (11.5, 14.4) 1989 163 (8.2) (7.0, 9.5)
Severe 2008 3 (0.1) (0.0, 0.4) 1989 3 (0.2) (0.0, 0.4)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
HeadachedHeadachee
Any 2008 503 (25.0) (23.2, 27.0) 1989 1990 363365 (18.3) (16.67, 20.01)
Mild 2008 381 (19.0) (17.3, 20.8) 1989 1990 267269 (13.45) (12.0, 15.01)
Moderate 2008 120 (6.0) (5.0, 7.1) 1989 1990 93 (4.7) (3.8, 5.7)
Severe 2008 2 (0.1) (0.0, 0.4) 1989 1990 3 (0.2) (0.0, 0.4)
Grade 4 2008 0 (0.0, 0.2) 1989 1990 0 (0.0, 0.2)
ChillsdChillse
Any 2008 130131 (6.5) (5.45, 7.67) 1989 69 (3.5) (2.7, 4.4)
Mild 2008 102103 (5.1) (4.2, 6.12) 1989 49 (2.5) (1.8, 3.2)
Moderate 2008 28 (1.4) (0.9, 2.0) 1989 19 (1.0) (0.6, 1.5)
Severe 2008 0 (0.0, 0.2) 1989 1 (0.1) (0.0, 0.3)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
VomitingeVomitingf
Any 2008 10 (0.5) (0.2, 0.9) 1989 9 (0.5) (0.2, 0.9)
Mild 2008 9 (0.4) (0.2, 0.8) 1989 9 (0.5) (0.2, 0.9)
Moderate 2008 1 (0.0) (0.0, 0.3) 1989 0 (0.0, 0.2)
Severe 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
DiarrheafDiarrheag
Any 2008 168 (8.4) (7.2, 9.7) 1989 1990 130131 (6.56) (5.5, 7.78)
Mild 2008 137 (6.8) (5.8, 8.0) 1989 1990 109110 (5.5) (4.56, 6.6)
Moderate 2008 27 (1.3) (0.9, 2.0) 1989 1990 20 (1.0) (0.6, 1.5)
Severe 2008 4 (0.2) (0.1, 0.5) 1989 1990 1 (0.1) (0.0, 0.3)
Grade 4 2008 0 (0.0, 0.2) 1989 1990 0 (0.0, 0.2)
New or worsened
muscle paindpaine
Any 2008 274 (13.6) (12.2, 15.2) 1989 165 (8.3) (7.1, 9.6)
Mild 2008 183 (9.1) (7.9, 10.5) 1989 111 (5.6) (4.6, 6.7)
Moderate 2008 90 (4.5) (3.6, 5.5) 1989 51 (2.6) (1.9, 3.4)
Severe 2008 1 (0.0) (0.0, 0.3) 1989 3 (0.2) (0.0, 0.4)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
New or worsened joint
paindpaine
Any 2008 175 (8.7) (7.5, 10.0) 1989 124 (6.2) (5.2, 7.4)
Mild 2008 119 (5.9) (4.9, 7.0) 1989 78 (3.9) (3.1, 4.9)
Moderate 2008 53 (2.6) (2.0, 3.4) 1989 45 (2.3) (1.7, 3.0)
Severe 2008 3 (0.1) (0.0, 0.4) 1989 1 (0.1) (0.0, 0.3)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any systemic
eventgeventh 2008 984985 (49.01) (46.8, 51.23) 1989 1990 749751 (37.7) (35.56, 39.89)
Use of antipyretic or
pain
medicationhmedicationi 2008 382 (19.0) (17.3, 20.8) 1989 224 (11.3) (9.9, 12.7)
2 Fever
≥38.0°C Any 1860 1862 219 (11.8 224 (1
2.0) (10.36, 13.36) 1833 4 (0.2) (0.1, 0.6)
≥38.0°C to 38.4°C 1860 1862 158 (8.5) (7.3, 9.98) 1833 2 (0.1) (0.0, 0.4)
>38.4°C to 38.9°C 1860 1862 54 (2.9) (2.2, 3.8) 1833 1 (0.1) (0.0, 0.3)
>38.9°C to 40.0°C 1860 1862 7 (0.4) (0.2, 0.8) 1833 1 (0.1) (0.0, 0.3)
>40.0°C 1860 1862 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Unknownd 1862 5 (0.3) (0.1, 0.6) 1833 0 (0.0, 0.2)
FatiguedFatiguee
Any 1860 1862 949952 (51.01) (48.78, 53.34) 1833 1834 306307 (16.7) (15.01, 18.5)
Mild 1860 1862 391393 (21.01) (19.2, 22.93, 23.0) 1833 1834 183184 (10.0) (8.67, 11.45)
Moderate 1860 1862 497498 (26.7) (24.7, 28.8) 1833 1834 121 (6.6) (5.5, 7.8)
Severe 1860 1862 60 (3.2) (2.5, 4.1) 1833 1834 2 (0.1) (0.0, 0.4)
Grade 4 1860 1862 1 (0.1) (0.0, 0.3) 1833 1834 0 (0.0, 0.2)
Headached Headachee
Any 1860 1867 733 (39.4)
742 (39.7) (37.2, 41.7)
(37.5, 42.0) 1833 259 (14.1) (12.6, 15.8)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 1860 1867 464 (24.9)
468 (25.1) (23.0, 27.0)
(23.1, 27.1) 1833 189 (10.3) (9.0, 11.8)
Moderate 1860 1867 256 (13.8)
261 (14.0) (12.2, 15.4)
(12.4, 15.6) 1833 65 (3.5) (2.7, 4.5)
Severe 1860 1867 13 (0.7) (0.4, 1.2) 1833 5 (0.3) (0.1, 0.6)
Grade 4 1860 1867 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Chillsd Chillse
Any 1860 1864 435 (23.4) (21.5, 25.4) 1833 57 (3.1) (2.4, 4.0)
Mild 1860 1864 229 (12.3) (10.9, 13.9) 1833 45 (2.5) (1.8, 3.3)
Moderate 1860 1864 185 (9.9) (8.6, 11.4) 1833 12 (0.7) (0.3, 1.1)
Severe 1860 1864 21 (1.1) (0.7, 1.7) 1833 0 (0.0, 0.2)
Grade 4 1860 1864 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Vomitinge Vomitingf
Any 1860 13 (0.7) (0.4, 1.2) 1833 5 (0.3) (0.1, 0.6)
Mild 1860 10 (0.5) (0.3, 1.0) 1833 5 (0.3) (0.1, 0.6)
Moderate 1860 1 (0.1) (0.0, 0.3) 1833 0 (0.0, 0.2)
Severe 1860 2 (0.1) (0.0, 0.4) 1833 0 (0.0, 0.2)
Grade 4 1860 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
DiarrheafDiarrheag
Any 1860 152154 (8.23) (7.01, 9.56) 1833 1834 102103 (5.6) (4.6, 6.78)
Mild 1860 125126 (6.78) (5.67, 8.0) 1833 1834 7677 (4.12) (3.3, 5.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 1860 2526 (1.34) (0.9, 2.0) 1833 1834 22 (1.2) (0.8, 1.8)
Severe 1860 2 (0.1) (0.0, 0.4) 1833 1834 4 (0.2) (0.1, 0.6)
Grade 4 1860 0 (0.0, 0.2) 1833 1834 0 (0.0, 0.2)
New or worsened
muscle paindpaine
Any 1860 1863 537 (28.9 540 (2
9.0) (26.89, 31.01) 1833 99 (5.4) (4.4, 6.5)
Mild 1860 1863 229 (12.3) (10.98, 13.9) 1833 65 (3.5) (2.7, 4.5)
Moderate 1860 1863 288291 (15.56) (13.914.0, 17.23) 1833 33 (1.8) (1.2, 2.5)
Severe 1860 1863 20 (1.1) (0.7, 1.7) 1833 1 (0.1) (0.0, 0.3)
Grade 4 1860 1863 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
New or worsened joint
paindpaine
Any 1860 1861 353355 (19.01) (17.23, 20.89) 1833 72 (3.9) (3.1, 4.9)
Mild 1860 1861 183184 (9.89) (8.56, 11.3) 1833 44 (2.4) (1.7, 3.2)
Moderate 1860 1861 161162 (8.7) (7.45, 10.01) 1833 27 (1.5) (1.0, 2.1)
Severe 1860 1861 9 (0.5) (0.2, 0.9) 1833 1 (0.1) (0.0, 0.3)
Grade 4 1860 1861 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Any systemic
eventgeventh 1860 1868 1203 (64.7 1214
(65.0 ) (62.5, 66.98, 67.2) 1833 1835 516518 (28.2) (26.12, 30.3)
Use of antipyretic or
pain
medicationhmedicationi 1860 688 (37.0) (34.8, 39.2) 1833 170 (9.3) (8.0, 10.7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any
dose Fever
≥38.0°C Any 2015 232238 (11.58) (10.24, 13.03) 1994 1112 (0.6) (0.3, 1.0)
≥38.0°C to 38.4°C 2015 168 (8.3) (7.2, 9.6) 1994 5 (0.3) (0.1, 0.6)
>38.4°C to 38.9°C 2015 56 (2.8) (2.1, 3.6) 1994 3 (0.2) (0.0, 0.4)
>38.9°C to 40.0°C 2015 8 (0.4) (0.2, 0.8) 1994 3 (0.2) (0.0, 0.4)
>40.0°C 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
Unknownd 2015 6 (0.3) (0.1, 0.6) 1994 1 (0.1) (0.0, 0.3)
Fatigued Fatiguee
Any 2015 1147 (56.9 1148
(57.0 ) (54.78, 59.1) 1994 586587 (29.4) (27.4, 31.45)
Mild 2015 485 (24.1) (22.2, 26.0) 1994 341342 (17.12) (15.5, 18.89)
Moderate 2015 598599 (29.7) (27.7, 31.78) 1994 240 (12.0) (10.6, 13.5)
Severe 2015 63 (3.1) (2.4, 4.0) 1994 5 (0.3) (0.1, 0.6)
Grade 4 2015 1 (0.0) (0.0, 0.3) 1994 0 (0.0, 0.2)
HeadachedHeadachee
Any 2015 925 (45.9 931 (4
6.2) (43.744.0, 48.14) 1994 1995 492494 (24.78) (22.89, 26.67)
Mild 2015 588589 (29.2) (27.23, 31.23) 1994 1995 345347 (17.34) (15.78, 19.01)
Moderate 2015 322327 (16.02) (14.46, 17.79) 1994 1995 139 (7.0) (5.9, 8.2)
Severe 2015 15 (0.7) (0.4, 1.2) 1994 1995 8 (0.4) (0.2, 0.8)
Grade 4 2015 0 (0.0, 0.2) 1994 1995 0 (0.0, 0.2)
ChillsdChillse
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 2015 499 (24.8 505 (2
5.1) (22.9, 26.723.2, 27.
0) 1994 110 (5.5) (4.6, 6.6)
Mild 2015 276281 (13.79) (12.25, 15.35) 1994 80 (4.0) (3.2, 5.0)
Moderate 2015 202203 (10.01) (8.78, 11.45) 1994 29 (1.5) (1.0, 2.1)
Severe 2015 21 (1.0) (0.6, 1.6) 1994 1 (0.1) (0.0, 0.3)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
VomitingeVomitingf
Any 2015 23 (1.1) (0.7, 1.7) 1994 14 (0.7) (0.4, 1.2)
Mild 2015 19 (0.9) (0.6, 1.5) 1994 14 (0.7) (0.4, 1.2)
Moderate 2015 2 (0.1) (0.0, 0.4) 1994 0 (0.0, 0.2)
Severe 2015 2 (0.1) (0.0, 0.4) 1994 0 (0.0, 0.2)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
DiarrheafDiarrheag
Any 2015 266268 (13.23) (11.8, 14.89) 1994 1995 199201 (10.01) (8.78, 11.45)
Mild 2015 210211 (10.45) (9.12, 11.89) 1994 1995 155157 (7.89) (6.67, 9.01)
Moderate 2015 5051 (2.5) (1.89, 3.3) 1994 1995 39 (2.0) (1.4, 2.7)
Severe 2015 6 (0.3) (0.1, 0.6) 1994 1995 5 (0.3) (0.1, 0.6)
Grade 4 2015 0 (0.0, 0.2) 1994 1995 0 (0.0, 0.2)
New or worsened
muscle paindpaine
Any 2015 655657 (32.56) (30.56, 34.67) 1994 221 (11.1) (9.7, 12.5)
Mild 2015 296 (14.7) (13.2, 16.3) 1994 138 (6.9) (5.8, 8.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 2015 338340 (16.89) (15.23, 18.56) 1994 79 (4.0) (3.1, 4.9)
Severe 2015 21 (1.0) (0.6, 1.6) 1994 4 (0.2) (0.1, 0.5)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
New or worsened joint
paindpaine
Any 2015 433435 (21.56) (19.78, 23.35) 1994 170 (8.5) (7.3, 9.8)
Mild 2015 227228 (11.3) (9.910.0, 12.78) 1994 98 (4.9) (4.0, 6.0)
Moderate 2015 194195 (9.67) (8.4, 11.01) 1994 70 (3.5) (2.7, 4.4)
Severe 2015 12 (0.6) (0.3, 1.0) 1994 2 (0.1) (0.0, 0.4)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
Any systemic
eventgeventh 2015 1432 1436 (71.13
) (69.02, 73.02) 1994 1995 919922 (46.12) (43.944.0, 48.34)
Use of antipyretic or
pain
medicationhmedicationi 2015 816 (40.5) (38.3, 42.7) 1994 319 (16.0) (14.4, 17.7)
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.
d. Only subjects with "P yrexia, Body temperature increased" dictionary terms and non- missing AE toxicity grade recorded in AE and missing e -diary
related fever measurements, are counted in this row.
e. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or
hospitalization for severe fatigue, severe headache, severe chills, severe muscle pain, or severe join t pain.
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Age
Group Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
ef. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency ro om visit or
hospitalization for severe vomiting.
fg. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 l oose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room
visit or hospitalization for severe diarrhea.
gh. Any systemic event: any fever ≥38.0°C , any fatigue, any vomiting, any chills, any diarrhea, any headache, an y new or worsened muscle pain, or any
new or worsened joint pain.
hi. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19: 29APR2021 ( 22:11) Source Data: adfacevd Table Generation: 27MAR2021
(01:55 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_ BLA sBLA CBER EDIARY /adce_s020_se_p3_saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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
Any≥38.0°C 54 2 (3.71 (1.9) (0.5, 12.70, 9.9) 56 4 (7.1) (2.0, 17.3)
≥38.0°C to 38.4°C 54 1 (1.9) (0.0, 9.9) 56 2 (3.6) (0.4, 12.3)
>38.4°C to 38.9°C 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
>38.9°C to 40.0°C 54 0 (0.0, 6.6) 56 2 (3.6) (0.4, 12.3)
>40.0°C 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
Unknownd 54 1 (1.9) (0.0, 9.9) 56 0 (0.0, 6.4)
FatigueeFatigued
Any 54 22 (40.7) (27.6, 55.0) 56 15 (26.8) (15.8, 40.3)
Mild 54 15 (27.8) (16.5, 41.6) 56 9 (16.1) (7.6, 28.3)
Moderate 54 7 (13.0) (5.4, 24.9) 56 5 (8.9) (3.0, 19.6)
Severe 54 0 (0.0, 6.6) 56 1 (1.8) (0.0, 9.6)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
HeadacheeHeadached
Any 54 11 (20.4) (10.6, 33.5) 56 18 (32.1) (20.3, 46.0)
Mild 54 7 (13.0) (5.4, 24.9) 56 10 (17.9) (8.9, 30.4)
Moderate 54 4 (7.4) (2.1, 17.9) 56 7 (12.5) (5.2, 24.1)
Severe 54 0 (0.0, 6.6) 56 1 (1.8) (0.0, 9.6)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
ChillseChillsd
Any 54 6 (11.1) (4.2, 22.6) 56 5 (8.9) (3.0, 19.6)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
Mild 54 5 (9.3) (3.1, 20.3) 56 4 (7.1) (2.0, 17.3)
Moderate 54 1 (1.9) (0.0, 9.9) 56 1 (1.8) (0.0, 9.6)
Severe 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
VomitingfVomitinge
Any 54 1 (1.9) (0.0, 9.9) 56 3 (5.4) (1.1, 14.9)
Mild 54 1 (1.9) (0.0, 9.9) 56 1 (1.8) (0.0, 9.6)
Moderate 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
Severe 54 0 (0.0, 6.6) 56 2 (3.6) (0.4, 12.3)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
DiarrheagDiarrheaf
Any 54 5 (9.3) (3.1, 20.3) 56 8 (14.3) (6.4, 26.2)
Mild 54 5 (9.3) (3.1, 20.3) 56 6 (10.7) (4.0, 21.9)
Moderate 54 0 (0.0, 6.6) 56 1 (1.8) (0.0, 9.6)
Severe 54 0 (0.0, 6.6) 56 1 (1.8) (0.0, 9.6)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
New or worsened muscle painepaind
Any 5554 10 (18.2 9 (16.7 ) (7.9.1, 30.9, 29.3) 56 10 (17.9) (8.9, 30.4)
Mild 5554 7 (12.713.0) (5.34, 24.59) 56 7 (12.5) (5.2, 24.1)
Moderate 5554 2 (3 (5.5.7) (1.1, 15.10.5, 12.7) 56 3 (5.4) (1.1, 14.9)
Severe 5554 0 (0.0, 6.56) 56 0 (0.0, 6.4)
Grade 4 5554 0 (0.0, 6.56) 56 0 (0.0, 6.4)
New or worsened joint painepaind
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
Any 54 5 (9.3) (3.1, 20.3) 56 7 (12.5) (5.2, 24.1)
Mild 54 5 (9.3) (3.1, 20.3) 56 4 (7.1) (2.0, 17.3)
Moderate 54 0 (0.0, 6.6) 56 3 (5.4) (1.1, 14.9)
Severe 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
Grade 4 54 0 (0.0, 6.6) 56 0 (0.0, 6.4)
Any systemic eventheventg 5554 33 (60.0 32 (59.3 ) (45.9, 73.0, 72.4) 56 32 (57.1) (43.2, 70.3)
Use of antipyretic or pain
medicationimedicationh 54 7 (13.0) (5.4, 24.9) 56 8 (14.3) (6.4, 26.2)
2 Fever
Any≥38.0°C 6160 13 (21.3 9 (15.0 ) (11.9, 33.7.1, 26.6) 62 5 (8.1) (2.7, 17.8)
≥38.0°C to 38.4°C 6160 4 (6.67) (1.8, 15.916.2) 62 5 (8.1) (2.7, 17.8)
>38.4°C to 38.9°C 6160 4 (6.67) (1.8, 15.916.2) 62 0 (0.0, 5.8)
>38.9°C to 40.0°C 6160 1 (1.67) (0.0, 8.89) 62 0 (0.0, 5.8)
>40.0°C 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
Unknownd 61 4 (6.6) (1.8, 15.9) 62 0 (0.0, 5.8)
FatigueeFatigued
Any 6260 26 (41.9 24 (40.0 ) (2927.6, 53.5, 55.2) 6362 13 (20.6 12 (19.4 ) (11.5, 32.710.4, 31.4)
Mild 6260 14 (22.6 12 (20.0 ) (12.9, 35.010.8, 32.3) 6362 6 (9.5 (8.1) (3.6, 19.62.7, 17.8)
Moderate 6260 9 (14.515.0) (7.1, 26.6.9, 25.8) 6362 7 (11.13) (4.67, 21.69)
Severe 6260 3 (4.85.0) (1.0, 13.59) 6362 0 (0.0, 5.78)
Grade 4 6260 0 (0.0, 5.86.0) 6362 0 (0.0, 5.78)
HeadacheeHeadached
Any 6160 19 (31.1 18 (30.0 ) (19.9, 44.318.8, 43.2) 62 12 (19.4) (10.4, 31.4)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
Mild 6160 9 (14.8 (13.3 ) (7.0, 26.25.9, 24.6) 62 8 (12.9) (5.7, 23.9)
Moderate 6160 8 (13.13) (5.89, 24.26) 62 4 (6.5) (1.8, 15.7)
Severe 6160 2 (3.3) (0.4, 11.35) 62 0 (0.0, 5.8)
Grade 4 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
ChillseChillsd
Any 6160 16 (26.2 14 (23.3 ) (15.8, 39.113.4, 36.0) 62 4 (6.5) (1.8, 15.7)
Mild 6160 6 (9.5 (8.3) (3.7, 20.2.8, 18.4) 62 3 (4.8) (1.0, 13.5)
Moderate 6160 8 (13.13) (5.89, 24.26) 62 1 (1.6) (0.0, 8.7)
Severe 6160 2 (3.31 (1.7) (0.4, 11.30, 8.9) 62 0 (0.0, 5.8)
Grade 4 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
VomitingfVomitinge
Any 60 2 (3.3) (0.4, 11.5) 62 2 (3.2) (0.4, 11.2)
Mild 60 1 (1.7) (0.0, 8.9) 62 1 (1.6) (0.0, 8.7)
Moderate 60 01 (1.7) (0.0, 6.08.9) 62 1 (1.6) (0.0, 8.7)
Severe 60 1 (1.7) 0 (0.0, 8.96.0) 62 0 (0.0, 5.8)
Grade 4 60 0 (0.0, 6.0) 62 0 (0.0, 5.8)
DiarrheagDiarrheaf
Any 60 4 (6.7) (1.8, 16.2) 62 9 (14.5) (6.9, 25.8)
Mild 60 1 (1.7) (0.0, 8.9) 62 6 (9.7) (3.6, 19.9)
Moderate 60 2 (3.3) (0.4, 11.5) 62 3 (4.8) (1.0, 13.5)
Severe 60 1 (1.7) (0.0, 8.9) 62 0 (0.0, 5.8)
Grade 4 60 0 (0.0, 6.0) 62 0 (0.0, 5.8)
New or worsened muscle painepaind
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
Any 6160 12 (1910 (16.7) (10.6, 31.8.3, 28.5) 62 5 (8.1) (2.7, 17.8)
Mild 6160 7 (11.5 (8.3) (2.8, 18.4.7, 22.2) 62 1 (1.6) (0.0, 8.7)
Moderate 6160 4 (6.65 (8.3) (12.8, 15.918.4) 62 4 (6.5) (1.8, 15.7)
Severe 6160 1 (1.6) 0 (0.0, 8.86.0) 62 0 (0.0, 5.8)
Grade 4 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
New or worsened joint painepaind
Any 6160 11 (18.0 10 (16.7 ) (9.4, 30.08.3, 28.5) 62 5 (8.1) (2.7, 17.8)
Mild 6160 5 (8.24 (6.7) (1.8, 16.2.7, 18.1) 62 1 (1.6) (0.0, 8.7)
Moderate 6160 6 (9.810.0) (3.78, 20.25) 62 4 (6.5) (1.8, 15.7)
Severe 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
Grade 4 6160 0 (0.0, 5.96.0) 62 0 (0.0, 5.8)
Any systemic eventheventg 6260 39 (62.9 36 (60.0 ) (49.7, 74.846.5, 72.4) 6362 24 (3823 (37.1) (26.1, 5125.2, 50.3)
Use of antipyretic or pain
medicationimedicationh 60 16 (26.7) (16.1, 39.7) 62 7 (11.3) (4.7, 21.9)
Any
dose Fever
Any≥38.0°C 7372 14 (19.2 9 (12.5 ) (105.9, 30.122.4) 74 7 (9.5) (3.9, 18.5)
≥38.0°C to 38.4°C 7372 4 (5.56) (1.5, 13.46) 74 5 (6.8) (2.2, 15.1)
>38.4°C to 38.9°C 7372 4 (5.56) (1.5, 13.46) 74 0 (0.0, 4.9)
>38.9°C to 40.0°C 7372 1 (1.4) (0.0, 7.45) 74 2 (2.7) (0.3, 9.4)
>40.0°C 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
Unknownd 73 5 (6.8) (2.3, 15.3) 74 0 (0.0, 4.9)
FatigueeFatigued
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
Any 7472 36 (48.6 34 (47.2 ) (36.9, 60.635.3, 59.3) 7574 21 (2820 (27.0) (18.2, 3917.4, 38.6)
Mild 7472 20 (2718 (25.0) (17.4, 3815.5, 36.6) 7574 9 (12.0 8 (10.8 ) (5.6, 21.64.8, 20.2)
Moderate 7472 13 (17.618.1) (9.710.0, 28.29) 7574 11 (14.79) (7.6, 24.7, 25.0)
Severe 7472 3 (4.12) (0.89, 11.47) 7574 1 (1.34) (0.0, 7.23)
Grade 4 7472 0 (0.0, 4.95.0) 7574 0 (0.0, 4.89)
HeadacheeHeadached
Any 7372 25 (34.2 24 (33.3 ) (23.5, 46.322.7, 45.4) 74 23 (31.1) (20.8, 42.9)
Mild 7372 13 (17.8 12 (16.7 ) (8.9.8, 28.5, 27.3) 74 13 (17.6) (9.7, 28.2)
Moderate 7372 10 (13.79) (6.8, 23.89, 24.1) 74 9 (12.2) (5.7, 21.8)
Severe 7372 2 (2.78) (0.3, 9.57) 74 1 (1.4) (0.0, 7.3)
Grade 4 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
ChillseChillsd
Any 7372 19 (26.0 17 (23.6 ) (16.5, 37.614.4, 35.1) 74 9 (12.2) (5.7, 21.8)
Mild 7372 8 (11.0 7 (9.7) (4.9, 20.50, 19.0) 74 7 (9.5) (3.9, 18.5)
Moderate 7372 9 (12.35) (5.89, 22.14) 74 2 (2.7) (0.3, 9.4)
Severe 7372 2 (2.71 (1.4) (0.3, 90, 7.5) 74 0 (0.0, 4.9)
Grade 4 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
VomitingfVomitinge
Any 72 3 (4.2) (0.9, 11.7) 74 3 (4.1) (0.8, 11.4)
Mild 72 2 (2.8) (0.3, 9.7) 74 1 (1.4) (0.0, 7.3)
Moderate 72 01 (1.4) (0.0, 7.5.0) 74 0 (0.0, 4.9)
Severe 72 1 (1.4) 0 (0.0, 7.5.0) 74 2 (2.7) (0.3, 9.4)
Grade 4 72 0 (0.0, 5.0) 74 0 (0.0, 4.9)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
DiarrheagDiarrheaf
Any 72 8 (11.1) (4.9, 20.7) 74 15 (20.3) (11.8, 31.2)
Mild 72 5 (6.9) (2.3, 15.5) 74 10 (13.5) (6.7, 23.5)
Moderate 72 2 (2.8) (0.3, 9.7) 74 4 (5.4) (1.5, 13.3)
Severe 72 1 (1.4) (0.0, 7.5) 74 1 (1.4) (0.0, 7.3)
Grade 4 72 0 (0.0, 5.0) 74 0 (0.0, 4.9)
New or worsened muscle painepaind
Any 7372 19 (26.0 17 (23.6 ) (16.5, 37.614.4, 35.1) 74 14 (18.9) (10.7, 29.7)
Mild 7372 13 (17.8 11 (15.3 ) (7.9.8, 28.5, 25.7) 74 8 (10.8) (4.8, 20.2)
Moderate 7372 5 (6. (8.3) (2.3, 15.1, 17.3) 74 6 (8.1) (3.0, 16.8)
Severe 7372 1 (1.4) 0 (0.0, 7.45.0) 74 0 (0.0, 4.9)
Grade 4 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
New or worsened joint painepaind
Any 7372 14 (19.2 13 (18.1 ) (10.0, 28.9, 30.1) 74 11 (14.9) (7.7, 25.0)
Mild 7372 8 (11.0 7 (9.7) (4.9, 20.50, 19.0) 74 5 (6.8) (2.2, 15.1)
Moderate 7372 6 (8.23) (3.1, 17.03) 74 6 (8.1) (3.0, 16.8)
Severe 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
Grade 4 7372 0 (0.0, 4.95.0) 74 0 (0.0, 4.9)
Any systemic eventheventg 7472 52 (70.3 50 (69.4 ) (5857.5, 80.379.8) 7574 40 (53.3 39 (52.7 ) (41.440.7, 64.94)
Use of antipyretic or pain
medicationimedicationh 72 20 (27.8) (17.9, 39.6) 74 12 (16.2) (8.7, 26.6)
Abbreviation: HIV = human immunodeficiency virus.
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
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive 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)
events were classified by the investigator or medic ally 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 "Pyrexia, Body temperature increased" dictionary terms and non- missing AE toxicity grade recorded in AE and missing e -diary
related fever measurements, are counted in this row.
e.
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 join t pain.
fe. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency ro om visit or
hospitalization for severe vomiting.
gf. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 l oose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room
visit or hospitalization for severe diarrhea.
hg. Any systemic event: any fever ≥38.0°C , any fatigue, any vomiting, any chills, any diarrhea, any headache, an y new or worsened muscle pain, or any
new or worsened joint pain.
ih. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:24 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s020 se hiv p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Positive 1 Fever
Any≥38.0°C 177 22 (12.4) (8.0, 18.2) 187 4 (2.1) (0.6, 5.4)
≥38.0°C to 38.4°C 177 17 (9.6) (5.7, 14.9) 187 1 (0.5) (0.0, 2.9)
>38.4°C to 38.9°C 177 4 (2.3) (0.6, 5.7) 187 1 (0.5) (0.0, 2.9)
>38.9°C to 40.0°C 177 1 (0.6) (0.0, 3.1) 187 2 (1.1) (0.1, 3.8)
>40.0°C 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Unknownd 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
FatigueeFatigued
Any 177 80 (45.2) (37.7, 52.8) 187 35 (18.7) (13.4, 25.1)
Mild 177 32 (18.1) (12.7, 24.6) 187 20 (10.7) (6.7, 16.0)
Moderate 177 47 (26.6) (20.2, 33.7) 187 15 (8.0) (4.6, 12.9)
Severe 177 1 (0.6) (0.0, 3.1) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
HeadacheeHeadached
Any 177 70 (39.5) (32.3, 47.2) 187 43 (23.0) (17.2, 29.7)
Mild 177 36 (20.3) (14.7, 27.0) 187 31 (16.6) (11.6, 22.7)
Moderate 177 31 (17.5) (12.2, 23.9) 187 9 (4.8) (2.2, 8.9)
Severe 177 3 (1.7) (0.4, 4.9) 187 3 (1.6) (0.3, 4.6)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
ChillseChillsd
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 177 49 (27.7) (21.2, 34.9) 187 8 (4.7 (3.7) (1.9, 8.35, 7.6)
Mild 177 33 (18.6) (13.2, 25.2) 187 54 (2.71) (0.9, 6.1, 5.4)
Moderate 177 14 (7.9) (4.4, 12.9) 187 3 (1.6) (0.3, 4.6)
Severe 177 2 (1.1) (0.1, 4.0) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
VomitingfVomitinge
Any 177 4 (2.3) (0.6, 5.7) 187 3 (1.6) (0.3, 4.6)
Mild 177 3 (1.7) (0.4, 4.9) 187 3 (1.6) (0.3, 4.6)
Moderate 177 1 (0.6) (0.0, 3.1) 187 0 (0.0, 2.0)
Severe 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
DiarrheagDiarrheaf
Any 177 10 (5.6) (2.7, 10.1) 187 13 (7.0) (3.8, 11.6)
Mild 177 9 (5.1) (2.4, 9.4) 187 10 (5.3) (2.6, 9.6)
Moderate 177 1 (0.6) (0.0, 3.1) 187 3 (1.6) (0.3, 4.6)
Severe 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
New or worsened muscle
painepaind
Any 177 55 (31.1) (24.3, 38.5) 187 20 (10.7) (6.7, 16.0)
Mild 177 18 (10.2) (6.1, 15.6) 187 13 (7.0) (3.8, 11.6)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 177 35 (19.8) (14.2, 26.4) 187 7 (3.7) (1.5, 7.6)
Severe 177 2 (1.1) (0.1, 4.0) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
New or worsened joint
painepaind
Any 177 33 (18.6) (13.2, 25.2) 187 10 (5.3) (2.6, 9.6)
Mild 177 20 (11.3) (7.0, 16.9) 187 5 (2.7) (0.9, 6.1)
Moderate 177 12 (6.8) (3.6, 11.5) 187 5 (2.7) (0.9, 6.1)
Severe 177 1 (0.6) (0.0, 3.1) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Any systemic eventheventg 177 115 (65.0) (57.5, 72.0) 187 77 (41.2) (34.0, 48.6)
Use of antipyretic or pain
medicationimedicationh 177 67 (37.9) (30.7, 45.4) 187 28 (15.0) (10.2, 20.9)
2 Fever
Any≥38.0°C 153 12 (7.8) (4.1, 13.3) 165 1 (0.6) (0.0, 3.3)
≥38.0°C to 38.4°C 153 11 (7.2) (3.6, 12.5) 165 0 (0.0, 2.2)
>38.4°C to 38.9°C 153 1 (0.7) (0.0, 3.6) 165 1 (0.6) (0.0, 3.3)
>38.9°C to 40.0°C 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
>40.0°C 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Unknownd 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
FatigueeFatigued
Any 153 56 (36.6) (29.0, 44.8) 165 27 (16.4) (11.1, 22.9)
Mild 153 23 (15.0) (9.8, 21.7) 165 11 (6.7) (3.4, 11.6)
Moderate 153 29 (19.0) (13.1, 26.1) 165 15 (9.1) (5.2, 14.6)
Severe 153 4 (2.6) (0.7, 6.6) 165 1 (0.6) (0.0, 3.3)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
HeadacheeHeadached
Any 153 54 (35.3) (27.7, 43.4) 165 32 (19.4) (13.7, 26.3)
Mild 153 29 (19.0) (13.1, 26.1) 165 18 (10.9) (6.6, 16.7)
Moderate 153 22 (14.4) (9.2, 21.0) 165 11 (6.7) (3.4, 11.6)
Severe 153 3 (2.0) (0.4, 5.6) 165 3 (1.8) (0.4, 5.2)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
ChillseChillsd
Any 153 29 (19.0) (13.1, 26.1) 165 2 (1.2) (0.1, 4.3)
Mild 153 15 (9.8) (5.6, 15.7) 165 2 (1.2) (0.1, 4.3)
Moderate 153 14 (9.2) (5.1, 14.9) 165 0 (0.0, 2.2)
Severe 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
VomitingfVomitinge
Any 153 2 (1.3) (0.2, 4.6) 165 4 (2.4) (0.7, 6.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 153 1 (0.7) (0.0, 3.6) 165 2 (1.2) (0.1, 4.3)
Moderate 153 0 (0.0, 2.4) 165 2 (1.2) (0.1, 4.3)
Severe 153 1 (0.7) (0.0, 3.6) 165 0 (0.0, 2.2)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
DiarrheagDiarrheaf
Any 153 10 (6.5) (3.2, 11.7) 165 16 (9.7) (5.6, 15.3)
Mild 153 6 (3.9) (1.5, 8.3) 165 10 (6.1) (2.9, 10.9)
Moderate 153 4 (2.6) (0.7, 6.6) 165 4 (2.4) (0.7, 6.1)
Severe 153 0 (0.0, 2.4) 165 2 (1.2) (0.1, 4.3)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
New or worsened muscle
painepaind
Any 153 42 (27.5) (20.6, 35.2) 165 14 (8.5) (4.7, 13.8)
Mild 153 16 (10.5) (6.1, 16.4) 165 7 (4.2) (1.7, 8.5)
Moderate 153 21 (13.7) (8.7, 20.2) 165 7 (4.2) (1.7, 8.5)
Severe 153 5 (3.3) (1.1, 7.5) 165 0 (0.0, 2.2)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
New or worsened joint
painepaind
Any 153 27 (17.6) (12.0, 24.6) 165 9 (5.5) (2.5, 10.1)
Mild 153 12 (7.8) (4.1, 13.3) 165 7 (4.2) (1.7, 8.5)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 153 15 (9.8) (5.6, 15.7) 165 2 (1.2) (0.1, 4.3)
Severe 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Any systemic eventheventg 153 87 (56.9) (48.6, 64.8) 165 50 (30.3) (23.4, 37.9)
Use of antipyretic or pain
medicationimedicationh 153 48 (31.4) (24.1, 39.4) 165 16 (9.7) (5.6, 15.3)
Any
dose Fever
Any≥38.0°C 177 31 (17.5) (12.2, 23.9) 187 5 (2.7) (0.9, 6.1)
≥38.0°C to 38.4°C 177 25 (14.1) (9.4, 20.1) 187 1 (0.5) (0.0, 2.9)
>38.4°C to 38.9°C 177 5 (2.8) (0.9, 6.5) 187 2 (1.1) (0.1, 3.8)
>38.9°C to 40.0°C 177 1 (0.6) (0.0, 3.1) 187 2 (1.1) (0.1, 3.8)
>40.0°C 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Unknownd 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
FatigueeFatigued
Any 177 96 (54.2) (46.6, 61.7) 187 50 (26.7) (20.5, 33.7)
Mild 177 33 (18.6) (13.2, 25.2) 187 24 (12.8) (8.4, 18.5)
Moderate 177 59 (33.3) (26.4, 40.8) 187 25 (13.4) (8.8, 19.1)
Severe 177 4 (2.3) (0.6, 5.7) 187 1 (0.5) (0.0, 2.9)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
HeadacheeHeadached
Any 177 88 (49.7) (42.1, 57.3) 187 59 (31.6) (25.0, 38.7)
Mild 177 39 (22.0) (16.2, 28.9) 187 35 (18.7) (13.4, 25.1)
Moderate 177 43 (24.3) (18.2, 31.3) 187 18 (9.6) (5.8, 14.8)
Severe 177 6 (3.4) (1.3, 7.2) 187 6 (3.2) (1.2, 6.9)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
ChillseChillsd
Any 177 58 (32.8) (25.9, 40.2) 187 10 (5.39 (4.8) (2.6, 2, 8.9.6)
Mild 177 34 (19.2) (13.7, 25.8) 187 76 (3.72) (1.5, 7.2, 6.9)
Moderate 177 22 (12.4) (8.0, 18.2) 187 3 (1.6) (0.3, 4.6)
Severe 177 2 (1.1) (0.1, 4.0) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
VomitingfVomitinge
Any 177 6 (3.4) (1.3, 7.2) 187 6 (3.2) (1.2, 6.9)
Mild 177 4 (2.3) (0.6, 5.7) 187 4 (2.1) (0.6, 5.4)
Moderate 177 1 (0.6) (0.0, 3.1) 187 2 (1.1) (0.1, 3.8)
Severe 177 1 (0.6) (0.0, 3.1) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
DiarrheagDiarrheaf
Any 177 18 (10.2) (6.1, 15.6) 187 27 (14.4) (9.7, 20.3)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 177 13 (7.3) (4.0, 12.2) 187 18 (9.6) (5.8, 14.8)
Moderate 177 5 (2.8) (0.9, 6.5) 187 7 (3.7) (1.5, 7.6)
Severe 177 0 (0.0, 2.1) 187 2 (1.1) (0.1, 3.8)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
New or worsened muscle
painepaind
Any 177 71 (40.1) (32.8, 47.7) 187 30 (16.0) (11.1, 22.1)
Mild 177 23 (13.0) (8.4, 18.9) 187 16 (8.6) (5.0, 13.5)
Moderate 177 42 (23.7) (17.7, 30.7) 187 14 (7.5) (4.2, 12.2)
Severe 177 6 (3.4) (1.3, 7.2) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
New or worsened joint
painepaind
Any 177 48 (27.1) (20.7, 34.3) 187 19 (10.2) (6.2, 15.4)
Mild 177 25 (14.1) (9.4, 20.1) 187 12 (6.4) (3.4, 10.9)
Moderate 177 22 (12.4) (8.0, 18.2) 187 7 (3.7) (1.5, 7.6)
Severe 177 1 (0.6) (0.0, 3.1) 187 0 (0.0, 2.0)
Grade 4 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Any systemic eventheventg 177 129 (72.9) (65.7, 79.3) 187 96 (51.3) (43.9, 58.7)
Use of antipyretic or pain
medicationimedicationh 177 77 (43.5) (36.1, 51.1) 187 38 (20.3) (14.8, 26.8)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Negative 1 Fever
Any≥38.0°C 4701 123121 (2.6) (2.21, 3.1) 4690 3029 (0.6) (0.4, 0.9)
≥38.0°C to 38.4°C 4701 92 (2.0) (1.6, 2.4) 4690 18 (0.4) (0.2, 0.6)
>38.4°C to 38.9°C 4701 22 (0.5) (0.3, 0.7) 4690 7 (0.1) (0.1, 0.3)
>38.9°C to 40.0°C 4701 7 (0.1) (0.1, 0.3) 4690 4 (0.1) (0.0, 0.2)
>40.0°C 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Unknownd 4701 2 (0.0) (0.0, 0.2) 4690 1 (0.0) (0.0, 0.1)
FatigueeFatigued
Any 4702 4701 2013 2011 (42.8) (41.4, 44.2) 4690 1368 (29.2) (27.9, 30.5)
Mild 4702 4701 1140 1138 (24.2) (23.0, 25.5) 4690 829 (17.7) (16.6, 18.8)
Moderate 4702 4701 832 (17.7) (16.6, 18.8) 4690 519 (11.1) (10.2, 12.0)
Severe 4702 4701 41 (0.9) (0.6, 1.2) 4690 20 (0.4) (0.3, 0.7)
Grade 4 4702 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
HeadacheeHeadached
Any 4703 4701 1682 1680 (35.87) (34.4, 37.21) 4692 4690 1294 1291 (27.65) (26.3, 28.98)
Mild 4703 4701 1124 1122 (23.9) (22.7, 25.1) 4692 4690 867865 (18.54) (17.43, 19.6)
Moderate 4703 4701 527 (11.2) (10.3, 12.1) 4692 4690 403402 (8.6) (7.8, 9.4)
Severe 4703 4701 31 (0.7) (0.4, 0.9) 4692 4690 24 (0.5) (0.3, 0.8)
Grade 4 4703 4701 0 (0.0, 0.1) 4692 4690 0 (0.0, 0.1)
ChillseChillsd
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 4702 4701 552549 (11.7) (10.8, 12.76) 4690 260 (5.5) (4.9, 6.2)
Mild 4702 4701 402401 (8.5) (7.87, 9.4) 4690 192 (4.1) (3.5, 4.7)
Moderate 4702 4701 138136 (2.9) (2.54, 3.54) 4690 65 (1.4) (1.1, 1.8)
Severe 4702 4701 12 (0.3) (0.1, 0.4) 4690 3 (0.1) (0.0, 0.2)
Grade 4 4702 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
VomitingfVomitinge
Any 4701 39 (0.8) (0.6, 1.1) 4690 41 (0.9) (0.6, 1.2)
Mild 4701 35 (0.7) (0.5, 1.0) 4690 35 (0.7) (0.5, 1.0)
Moderate 4701 4 (0.1) (0.0, 0.2) 4690 5 (0.1) (0.0, 0.2)
Severe 4701 0 (0.0, 0.1) 4690 1 (0.0) (0.0, 0.1)
Grade 4 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
DiarrheagDiarrheaf
Any 4701 462 (9.8) (9.0, 10.7) 4691 4690 441439 (9.4) (8.65, 10.32)
Mild 4701 375 (8.0) (7.2, 8.8) 4691 4690 364362 (7.87) (7.0, 8.65)
Moderate 4701 80 (1.7) (1.4, 2.1) 4691 4690 75 (1.6) (1.3, 2.0)
Severe 4701 7 (0.1) (0.1, 0.3) 4691 4690 2 (0.0) (0.0, 0.2)
Grade 4 4701 0 (0.0, 0.1) 4691 4690 0 (0.0, 0.1)
New or worsened muscle
painepaind
Any 4702 4701 878875 (18.76) (17.65, 19.8) 4690 471 (10.0) (9.2, 10.9)
Mild 4702 4701 517515 (11.0) (10.1, 11.9) 4690 327 (7.0) (6.3, 7.7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 4702 4701 348347 (7.4) (6.76, 8.2) 4690 139 (3.0) (2.5, 3.5)
Severe 4702 4701 13 (0.3) (0.1, 0.5) 4690 5 (0.1) (0.0, 0.2)
Grade 4 4702 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
New or worsened joint
painepaind
Any 4701 480 (10.2) (9.4, 11.1) 4690 282 (6.0) (5.3, 6.7)
Mild 4701 298 (6.3) (5.7, 7.1) 4690 185 (3.9) (3.4, 4.5)
Moderate 4701 176 (3.7) (3.2, 4.3) 4690 95 (2.0) (1.6, 2.5)
Severe 4701 6 (0.1) (0.0, 0.3) 4690 2 (0.0) (0.0, 0.2)
Grade 4 4701 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Any systemic eventheventg 4703 4701 2830 2825 (60.21) (58.87, 61.65) 4692 4690 2226 2223 (47.4) (46.0, 48.98)
Use of antipyretic or pain
medicationimedicationh 4701 1109 (23.6) (22.4, 24.8) 4690 592 (12.6) (11.7, 13.6)
2 Fever
Any≥38.0°C 4379 4368 666 (15.2 645 (14.8 ) (14.2, 16.313.7, 15.9) 4335 4334 1513 (0.3) (0.2, 0.65)
≥38.0°C to 38.4°C 4379 4368 399 (9.1) (8.3, 10.0) 4335 4334 7 (0.2) (0.1, 0.3)
>38.4°C to 38.9°C 4379 4368 199 (4.56) (3.94.0, 5.2) 4335 4334 3 (0.1) (0.0, 0.2)
>38.9°C to 40.0°C 4379 4368 46 (1.1) (0.8, 1.4) 4335 4334 3 (0.1) (0.0, 0.2)
>40.0°C 4379 4368 1 (0.0) (0.0, 0.1) 4335 4334 0 (0.0, 0.1)
Unknownd 4379 21 (0.5) (0.3, 0.7) 4335 2 (0.0) (0.0, 0.2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
FatigueeFatigued
Any 4378 4368 2545 2532 (58.10) (56.75, 59.64) 4335 4334 893889 (20.65) (19.43, 21.87)
Mild 4378 4368 930923 (21.21) (20.019.9, 22.54) 4335 4334 493489 (11.43) (10.4, 12.43)
Moderate 4378 4368 1415 1411 (32.3) (30.9, 33.7) 4335 4334 385 (8.9) (8.1, 9.8)
Severe 4378 4368 199197 (4.5) (3.9, 5.2) 4335 4334 15 (0.3) (0.2, 0.6)
Grade 4 4378 4368 1 (0.0) (0.0, 0.1) 4335 4334 0 (0.0, 0.1)
HeadacheeHeadached
Any 4381 4368 2135 2118 (48.75) (47.20, 50.20) 4336 4334 880875 (20.32) (19.10, 21.54)
Mild 4381 4368 1139 (26.0 1130 (25.9 ) (24.76, 27.32) 4336 4334 579574 (13.42) (12.42, 14.43)
Moderate 4381 4368 896889 (20.54) (19.32, 21.76) 4336 4334 281 (6.5) (5.8, 7.3)
Severe 4381 4368 10099 (2.3) (1.98, 2.8) 4336 4334 20 (0.5) (0.3, 0.7)
Grade 4 4381 4368 0 (0.0, 0.1) 4336 4334 0 (0.0, 0.1)
ChillseChillsd
Any 4378 4368 1431 1417 (32.74) (31.3, 34.1, 33.9) 4334 169168 (3.9) (3.3, 4.5)
Mild 4378 4368 699 (16.0 690 (15.8 ) (14.7, 16.9, 17.1) 4334 133132 (3.10) (2.6, 3.6)
Moderate 4378 4368 642637 (14.76) (13.65, 15.7) 4334 34 (0.8) (0.5, 1.1)
Severe 4378 4368 90 (2.1) (1.7, 2.5) 4334 2 (0.0) (0.0, 0.2)
Grade 4 4378 4368 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
VomitingfVomitinge
Any 4368 69 (1.6) (1.2, 2.0) 4334 31 (0.7) (0.5, 1.0)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 4368 51 (1.2) (0.9, 1.5) 4334 23 (0.5) (0.3, 0.8)
Moderate 4368 13 (0.3) (0.2, 0.5) 4334 8 (0.2) (0.1, 0.4)
Severe 4368 5 (0.1) (0.0, 0.3) 4334 0 (0.0, 0.1)
Grade 4 4368 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
DiarrheagDiarrheaf
Any 4368 412410 (9.4) (8.65, 10.3) 4336 4334 291289 (6.7) (6.05.9, 7.5)
Mild 4368 338337 (7.7) (7.06.9, 8.65) 4336 4334 235233 (5.4) (4.87, 6.1)
Moderate 4368 6665 (1.5) (1.2, 1.9) 4336 4334 53 (1.2) (0.9, 1.6)
Severe 4368 8 (0.2) (0.1, 0.4) 4336 4334 3 (0.1) (0.0, 0.2)
Grade 4 4368 0 (0.0, 0.1) 4336 4334 0 (0.0, 0.1)
New or worsened muscle
painepaind
Any 4381 4368 1565 1548 (35.74) (34.3, 37.20, 36.9) 4334 319 (7.4) (6.6, 8.2)
Mild 4381 4368 663654 (15.10) (14.113.9, 16.21) 4334 206 (4.8) (4.1, 5.4)
Moderate 4381 4368 825817 (18.87) (17.7, 20.06, 19.9) 4334 109 (2.5) (2.1, 3.0)
Severe 4381 4368 77 (1.8) (1.4, 2.2) 4334 4 (0.1) (0.0, 0.2)
Grade 4 4381 4368 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
New or worsened joint
painepaind
Any 4371 4368 969962 (22.20) (20.98, 23.43) 4334 209 (4.8) (4.2, 5.5)
Mild 4371 4368 464461 (10.6) (9.7, 11.65) 4334 118 (2.7) (2.3, 3.3)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 4371 4368 469465 (10.76) (9.87, 11.76) 4334 86 (2.0) (1.6, 2.4)
Severe 4371 4368 36 (0.8) (0.6, 1.1) 4334 5 (0.1) (0.0, 0.3)
Grade 4 4371 4368 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
Any systemic eventheventg 4396 4368 3171 (72.1 3137 (71.8 ) (70.85, 73.51) 4339 4334 1493 1485 (34.43) (33.032.9, 35.87)
Use of antipyretic or pain
medicationimedicationh 4368 1845 (42.2) (40.8, 43.7) 4334 470 (10.8) (9.9, 11.8)
Any
dose Fever
Any≥38.0°C 4718 736714 (15.61) (14.61, 16.72) 4709 4708 4239 (0.98) (0.6, 1.21)
≥38.0°C to 38.4°C 4718 451 (9.6) (8.7, 10.4) 4709 4708 24 (0.5) (0.3, 0.8)
>38.4°C to 38.9°C 4718 213 (4.5) (3.9, 5.1) 4709 4708 9 (0.2) (0.1, 0.4)
>38.9°C to 40.0°C 4718 49 (1.0) (0.8, 1.4) 4709 4708 6 (0.1) (0.0, 0.3)
>40.0°C 4718 1 (0.0) (0.0, 0.1) 4709 4708 0 (0.0, 0.1)
Unknownd 4718 22 (0.5) (0.3, 0.7) 4709 3 (0.1) (0.0, 0.2)
FatigueeFatigued
Any 4718 3074 3069 (65.20) (63.87, 66.54) 4708 1702 1701 (36.21) (34.8, 37.5)
Mild 4718 1119 1118 (23.7) (22.5, 25.024.9) 4708 931930 (19.8) (18.6, 20.9)
Moderate 4718 1721 1719 (36.54) (35.1, 37.98) 4708 740 (15.7) (14.7, 16.8)
Severe 4718 233231 (4.9) (4.3, 5.6) 4708 31 (0.7) (0.4, 0.9)
Grade 4 4718 1 (0.0) (0.0, 0.1) 4708 0 (0.0, 0.1)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
HeadacheeHeadached
Any 4718 2718 2708 (57.64) (56.2, 59.0, 58.8) 4710 4708 1656 1650 (35.20) (33.87, 36.54)
Mild 4718 1414 (30.0 1410 (29.9 ) (28.76, 31.32) 4710 4708 1040 1035 (22.10) (20.98, 23.32)
Moderate 4718 1179 (25.0 1174 (24.9 ) (23.87, 26.31) 4710 4708 573572 (12.21) (11.2, 13.1)
Severe 4718 125124 (2.6) (2.2, 3.1) 4710 4708 43 (0.9) (0.7, 1.2)
Grade 4 4718 0 (0.0, 0.1) 4710 4708 0 (0.0, 0.1)
ChillseChillsd
Any 4718 1651 (35.0 1638 (34.7 ) (33.64, 36.41) 4708 370369 (7.98) (7.1, 8.76)
Mild 4718 841832 (17.86) (16.76, 18.98) 4708 279278 (5.9) (5.32, 6.6)
Moderate 4718 710706 (15.0) (14.0, 16.10) 4708 86 (1.8) (1.5, 2.3)
Severe 4718 100 (2.1) (1.7, 2.6) 4708 5 (0.1) (0.0, 0.2)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
VomitingfVomitinge
Any 4718 103 (2.2) (1.8, 2.6) 4708 67 (1.4) (1.1, 1.8)
Mild 4718 82 (1.7) (1.4, 2.2) 4708 53 (1.1) (0.8, 1.5)
Moderate 4718 16 (0.3) (0.2, 0.6) 4708 13 (0.3) (0.1, 0.5)
Severe 4718 5 (0.1) (0.0, 0.2) 4708 1 (0.0) (0.0, 0.1)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
DiarrheagDiarrheaf
Any 4718 737735 (15.6) (14.6, 16.76) 4709 4708 633629 (13.4) (12.54, 14.4)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Mild 4718 587586 (12.4) (11.5, 13.4) 4709 4708 507503 (10.87) (9.98, 11.76)
Moderate 4718 135134 (2.98) (2.4, 3.4) 4709 4708 121 (2.6) (2.1, 3.1)
Severe 4718 15 (0.3) (0.2, 0.5) 4709 4708 5 (0.1) (0.0, 0.2)
Grade 4 4718 0 (0.0, 0.1) 4709 4708 0 (0.0, 0.1)
New or worsened muscle
painepaind
Any 4718 1913 1901 (40.53) (39.1, 42.038.9, 41.7) 4708 658 (14.0) (13.0, 15.0)
Mild 4718 806802 (17.10) (16.015.9, 18.21) 4708 423 (9.0) (8.2, 9.8)
Moderate 4718 1019 1011 (21.64) (20.43, 22.86) 4708 226 (4.8) (4.2, 5.5)
Severe 4718 88 (1.9) (1.5, 2.3) 4708 9 (0.2) (0.1, 0.4)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
New or worsened joint
painepaind
Any 4718 1186 1179 (25.10) (23.98, 26.43) 4708 422 (9.0) (8.2, 9.8)
Mild 4718 563560 (11.9) (11.0, 12.98) 4708 246 (5.2) (4.6, 5.9)
Moderate 4718 581577 (12.32) (11.43, 13.32) 4708 169 (3.6) (3.1, 4.2)
Severe 4718 42 (0.9) (0.6, 1.2) 4708 7 (0.1) (0.1, 0.3)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
Any systemic eventheventg 4718 3734 3725 (79.10) (78.077.8, 80.31) 4710 4708 2613 2609 (55.54) (54.0, 56.98)
Use of antipyretic or pain
medicationimedicationh 4718 2209 (46.8) (45.4, 48.3) 4708 881 (18.7) (17.6, 19.9)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Systemic Events, by Maximum Severity, Within 7 Days After Each Dose, by Baseline SARS -CoV -2 Status
(Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Baseline
SARS -
CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Abbreviation: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
Note: Subjects whose baseline SARS -CoV -2 status cannot be determined because of missing N -binding antibody or NAAT at Visit 1 were not included in
the analysis.
Note: Positive = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. Negative = negative N -
binding antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID- 19.
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 "Pyrexia, Body temperature increased" dictionary terms and non- missing AE toxicity grade recorded in AE and missing e -diary
related fever measurements, are counted in this row.
e.
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.
fe. 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.
gf. 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.
hg. 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.
ih. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:24 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snap shot Date: 25MAR2021) Output File:
./nda2_unblinded/C4591001_ sBLA CBER EDIARY BLA /adce_s020_se_base_p3_saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
16-55 Years 1 FeveraFever (≥38.0°C)
nbna 120119 25
Mean (SD) 1.2 (0.87) 1.7 (1.52)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
UnknowncUnknownb 0 1
Fatigue
nbna 1433 1431 960
Mean (SD) 2.5 (2. 5150) 2.9 (2. 9389)
Median 1.0 2.0
Min, max (1, 23) (1, 23)
UnknowncUnknownb 6 5
Headache
nbna 1264 1262 976975
Mean (SD) 2.4 (2.45) 2.6 (2.62)
Median 1.0 1.0
Min, max (1, 25) (1, 22)
UnknowncUnknownb 5 4
Chills
nbna 481479 200199
Mean (SD) 1.6 (1. 3534) 2.1 (2.77)
Median 1.0 1.0
Min, max (1, 9) (1, 31)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
UnknowncUnknownb 1 2
Vomiting
nbna 34 36
Mean (SD) 1.5 (1.13) 1.4 (0.91)
Median 1.0 1.0
Min, max (1, 5) (1, 4)
Diarrhea
nbna 309 324323
Mean (SD) 2.0 (2.97) 1.8 (1.91)
Median 1.0 1.0
Min, max (1, 39) (1, 23)
UnknowncUnknownb 1 0
New or worsened muscle pain
nbna 667664 329
Mean (SD) 1.7 (1. 7763) 2.0 (2.56)
Median 1.0 1.0
Min, max (1, 2017) (1, 31)
UnknowncUnknownb 1 1
New or worsened joint pain
nbna 342 168
Mean (SD) 1.6 (1. 7774) 2.2 (2.38)
Median 1.0 1.0
Min, max (1, 24) (1, 17)
UnknowncUnknownb 32 0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Use of antipyretic or pain medication
nbna 805 398
Mean (SD) 1.9 (1.76) 2.2 (2.44)
Median 1.0 1.0
Min, max (1, 16) (1, 23)
UnknowncUnknownb 1 4
2 FeveraFever (≥38.0°C)
nbna 456440 1311
Mean (SD) 1.2 (1.03 (0.51 ) 2.41 (2.0208)
Median 1.0 1.0
Min, max (1, 198) (1, 6)
UnknowncUnknownb 0 1
Fatigue
nbna 1659 1649 617614
Mean (SD) 2.2 (2.14) 2.8 (3.04)
Median 1.0 2.0
Min, max (1, 35) (1, 38)
UnknowncUnknownb 5 10
Headache
nbna 1456 1448 657652
Mean (SD) 2.2 (2. 1901) 2.54 (3.0100)
Median 1.0 1.0
Min, max (1, 4225) (1, 35)
UnknowncUnknownb 5 10
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Chills
nbna 1024 1015 115114
Mean (SD) 1.3 (0. 8281) 2.2 (1. 9899)
Median 1.0 1.0
Min, max (1, 11) (1, 10)
UnknowncUnknownb 3 2
Vomiting
nbna 58 30
Mean (SD) 2.4 (5.27) 1.5 (1.15)
Median 1.0 1.0
Min, max (1, 37) (1, 6)
UnknowncUnknownb 1 1
Diarrhea
nbna 269 206205
Mean (SD) 1.8 (2.31) 2.21 (3.3332)
Median 1.0 1.0
Min, max (1, 31) (1, 33)
UnknowncUnknownb 1 3
New or worsened muscle pain
nbna 1069 1055 237
Mean (SD) 1.5 (1. 3534) 2.3 (2.71)
Median 1.0 1.0
Min, max (1, 23) (1, 27)
UnknowncUnknownb 3 1
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
New or worsened joint pain
nbna 643638 147
Mean (SD) 1.6 (1. 7775) 2.2 (2.28)
Median 1.0 1.0
Min, max (1, 28) (1, 16)
UnknowncUnknownb 5 2
Use of antipyretic or pain medication
nbna 1213 320
Mean (SD) 1.9 (2.00) 2.1 (2.83)
Median 1.0 1.0
Min, max (1, 34) (1, 38)
UnknowncUnknownb 6 9
>55 Years 1 FeveraFever (≥38.0°C)
nbna 2726 98
Mean (SD) 1.21 (0.4833) 1.9 (2.320 (2.45 )
Median 1.0 1.0
Min, max (1, 32) (1, 8)
Fatigue
nbna 677 447
Mean (SD) 2.4 (2.74) 2.8 (3. 4340)
Median 1.0 1.0
Min, max (1, 34) (1, 23)
UnknowncUnknownb 1 3
Headache
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
nbna 503 365363
Mean (SD) 2.0 (1.86) 2.3 (2. 6566)
Median 1.0 1.0
Min, max (1, 17) (1, 20)
UnknowncUnknownb 0 4
Chills
nbna 131130 69
Mean (SD) 1.6 (1.35) 2.1 (2.13)
Median 1.0 1.0
Min, max (1, 11) (1, 13)
UnknowncUnknownb 1 1
Vomiting
nbna 10 9
Mean (SD) 1.6 (1.58) 1.5 (1.07)
Median 1.0 1.0
Min, max (1, 6) (1, 4)
UnknowncUnknownb 0 1
Diarrhea
nbna 168 131130
Mean (SD) 1.8 (1.58) 2.3 (3. 3437)
Median 1.0 1.0
Min, max (1, 8) (1, 22)
UnknowncUnknownb 1 01
New or worsened muscle pain
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
nbna 274 165
Mean (SD) 1.5 (1.37) 1.98 (2.4644)
Median 1.0 1.0
Min, max (1, 14) (1, 18)
UnknowncUnknownb 1 0
New or worsened joint pain
nbna 175 124
Mean (SD) 1.9 (3. 3226) 1.9 (2.33)
Median 1.0 1.0
Min, max (1, 36) (1, 17)
Use of antipyretic or pain medication
nbna 382 224
Mean (SD) 2.0 (2.49) 2.8 (3.27)
Median 1.0 1.0
Min, max (1, 31) (1, 22)
UnknowncUnknownb 5 7
2 FeveraFever (≥38.0°C)
nbna 224219 4
Mean (SD) 1.1 (0. 5435) 1.8 (1.50)
Median 1.0 1.0
Min, max (1, 64) (1, 4)
Fatigue
nbna 952949 307306
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Mean (SD) 2.1 (1.88) 2.87 (4.9788)
Median 1.0 1.0
Min, max (1, 20) (1, 69)
UnknowncUnknownb 3 9
Headache
nbna 742733 259
Mean (SD) 1.8 (1.43) 2.4 (2.81)
Median 1.0 1.0
Min, max (1, 12) (1, 34)
UnknowncUnknownb 2 3
Chills
nbna 440435 57
Mean (SD) 1.2 (0.6362) 2.3 (2.72)
Median 1.0 1.0
Min, max (1, 7) (1, 16)
UnknowncUnknownb 1 2
Vomiting
nbna 13 5
Mean (SD) 1.2 (0. 6038) 1.0 (0.00)
Median 1.0 1.0
Min, max (1, 32) (1, 1)
Diarrhea
nbna 154152 103102
Mean (SD) 1.8 (1. 4543) 2.1 (2.83)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Median 1.0 1.0
Min, max (1, 9) (1, 26)
UnknowncUnknownb 2 2
New or worsened muscle pain
nbna 540537 99
Mean (SD) 1.4 (0. 9794) 1.6 (1.29)
Median 1.0 1.0
Min, max (1, 7) (1, 8)
UnknowncUnknownb 1 3
New or worsened joint pain
nbna 355353 72
Mean (SD) 1.65 (2.4602) 2.0 (1.71)
Median 1.0 1.0
Min, max (1, 32) (1, 8)
UnknowncUnknownb 2 1
Use of antipyretic or pain medication
nbna 688 170
Mean (SD) 1.8 (1.86) 2.0 (1.96)
Median 1.0 1.0
Min, max (1, 30) (1, 10)
UnknowncUnknownb 3 9
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
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
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
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.
cb. Includes those events where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:0625MAR2021 (19:19) Source Data: adcevd Table Generation: 29APR2021
(23:22 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s040 se dur p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
1 FeveraFever (≥38.0°C)
nbna 21 4
Mean (SD) 1.5 (0.71 (NE) 1.8 (0.96)
Median 1.50 1.5
Min, max (1, 21) (1, 3)
Fatigue
nbna 22 15
Mean (SD) 2.5 (2.11) 3.0 (2.07)
Median 1.5 3.0
Min, max (1, 9) (1, 7)
Headache
nbna 11 18
Mean (SD) 3.0 (2.65) 2.9 (2.50)
Median 1.0 2.0
Min, max (1, 7) (1, 7)
UnknowncUnknownb 0 1
Chills
nbna 6 5
Mean (SD) 2.6 (2.61 (2.68 ) 1.8 (0.50)
Median 1.0 2.0
Min, max (1, 7) (1, 2)
UnknowncUnknownb 1 1
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Vomiting
nbna 1 3
Mean (SD) 1.0 (NE) 2.0 (1.00)
Median 1.0 2.0
Min, max (1, 1) (1, 3)
Diarrhea
nbna 5 8
Mean (SD) 2.0 (1.73) 1.5 (0.76)
Median 1.0 1.0
Min, max (1, 5) (1, 3)
New or worsened muscle pain
nbna 109 10
Mean (SD) 1.63 (0.9750) 2.0 (1.948 (1.93 )
Median 1.0 1.0
Min, max (1, 42) (1, 7)
New or worsened joint pain
nbna 5 7
Mean (SD) 1.4 (0.55) 2.0 (1.91)
Median 1.0 1.0
Min, max (1, 2) (1, 6)
Use of antipyretic or pain medication
nbna 7 8
Mean (SD) 2.4 (2.15) 2.3 (1.91)
Median 1.0 1.0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Min, max (1, 6) (1, 6)
2 FeveraFever (≥38.0°C)
nbna 139 5
Mean (SD) 2.0 (1.224 (0.88 ) 1.8 (1.30)
Median 21.0 1.0
Min, max (1, 53) (1, 4)
Fatigue
nbna 2624 1312
Mean (SD) 3.3 (2 (2.54 .63) 2.89 (1.9192)
Median 2.0 2.0
Min, max (1, 10) (1, 6)
UnknowncUnknownb 0 1
Headache
nbna 1918 12
Mean (SD) 2.2 (1.40 (1.45 ) 2.3 (1.56)
Median 2.01.5 2.0
Min, max (1, 5) (1, 5)
UnknowncUnknownb 0 1
Chills
nbna 1614 4
Mean (SD) 1.7 (1.08 2 (0.43 ) 1.3 (0.50)
Median 1.0 1.0
Min, max (1, 52) (1, 2)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Vomiting
nbna 2 2
Mean (SD) 21.0 (1.410.00) 5.5 (2.12)
Median 21.0 5.5
Min, max (1, 31) (4, 7)
Diarrhea
nbna 4 9
Mean (SD) 2.3 (2.50) 2.1 (2.26)
Median 1.0 1.0
Min, max (1, 6) (1, 8)
New or worsened muscle pain
nbna 1210 5
Mean (SD) 2.7 (1.569 (1.60 ) 2.2 (1.64)
Median 2.51.0 2.0
Min, max (1, 6) (1, 5)
New or worsened joint pain
nbna 1110 5
Mean (SD) 1.5 (0. 9397) 1.2 (0.45)
Median 1.0 1.0
Min, max (1, 4) (1, 2)
Use of antipyretic or pain medication
nbna 16 7
Mean (SD) 2.0 (2.00) 1.6 (1.51)
Median 1.0 1.0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Duration (Days) From First to Last Day of Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Min, max (1, 6) (1, 5)
Abbreviations: HIV = human immunodeficiency virus; 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
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.
cb. Includes those events where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:0625MAR2021 (19:19) Source Data: adcevd Table Generation: 29APR2021
(23:22 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unblinded/C4591001_ sBLA CBER EDIARY BLA /adce_s040_se_dur_hiv_p3_saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
16-55 Years 1 FeveraFever (≥38.0°C)
nbna 120119 25
Mean (SD) 2.5 (1.24) 3.7 (2.10)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Fatigue
nbna 1433 1431 960
Mean (SD) 2.0 (1.23) 2.3 (1.62)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nbna 1264 1262 976975
Mean (SD) 2.4 (1. 5253) 2.6 (1.71)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Chills
nbna 481479 200199
Mean (SD) 2.2 (1.23) 2.9 (1.78)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Vomiting
nbna 34 36
Mean (SD) 3.8 (1.85) 3.6 (2.03)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Median 4.0 4.0
Min, max (1, 7) (1, 7)
Diarrhea
nbna 309 324323
Mean (SD) 3.5 (1.68) 3.6 (1.77)
Median 3.0 3.0
Min, max (1, 7) (1, 7)
New or worsened muscle pain
nbna 667664 329
Mean (SD) 2.3 (1. 2120) 3.1 (1.78)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
New or worsened joint pain
nbna 342 168
Mean (SD) 2.6 (1. 4243) 3.4 (1.61)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Any systemic eventceventb
nbna 1983 1979 1560 1559
Mean (SD) 2.0 (1. 2122) 2.3 (1.59)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
nbna 805 398
Mean (SD) 2.4 (1.33) 3.4 (1.85)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
2 FeveraFever (≥38.0°C)
nbna 456440 1311
Mean (SD) 2.0 (0. 5553) 3.56 (2.1125)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Fatigue
nbna 1659 1649 617614
Mean (SD) 1.9 (0.76) 2.4 (1. 6160)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nbna 1456 1448 657652
Mean (SD) 2.1 (1. 0102) 2.8 (1.75)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Chills
nbna 1024 1015 115114
Mean (SD) 1.9 (0.54) 2.7 (1. 6463)
Median 2.0 2.0
Min, max (1, 6) (1, 7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Vomiting
nbna 58 30
Mean (SD) 2.6 (1.38) 3.8 (2.12)
Median 2.0 4.0
Min, max (1, 7) (1, 7)
Diarrhea
nbna 269 206205
Mean (SD) 3.2 (1.71) 3.7 (1.92)
Median 3.0 3.0
Min, max (1, 7) (1, 7)
New or worsened muscle pain
nbna 1069 1055 237
Mean (SD) 2.0 (0.66) 3.0 (1.83)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
New or worsened joint pain
nbna 643638 147
Mean (SD) 2.1 (0. 8081) 3.3 (1.82)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Any systemic eventceventb
nbna 2057 2034 1032 1026
Mean (SD) 1.8 (0.85) 2.4 (1.62)
Median 2.0 2.0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
nbna 1213 320
Mean (SD) 2.0 (0.77) 3.4 (1.79)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
>55 Years 1 FeveraFever (≥38.0°C)
nbna 2726 98
Mean (SD) 2.43 (1.2123) 3.9 (4.1.69 (1.64 )
Median 2.0 4.0
Min, max (1, 6) (2, 7)
Fatigue
nbna 677 447
Mean (SD) 2.2 (1.27) 2.6 (1.69)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nbna 503 365363
Mean (SD) 2.5 (1. 5152) 2.8 (1.75)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Chills
nbna 131130 69
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Mean (SD) 2.5 (1.52) 3.0 (1.87)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Vomiting
nbna 10 9
Mean (SD) 3.1 (1.91) 3.7 (1.73)
Median 2.5 4.0
Min, max (1, 7) (1, 7)
Diarrhea
nbna 168 131130
Mean (SD) 3.4 (1.77) 3.6 (1.71)
Median 3.0 3.0
Min, max (1, 7) (1, 7)
New or worsened muscle pain
nbna 274 165
Mean (SD) 2.6 (1.45) 3.5 (1.84)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
New or worsened joint pain
nbna 175 124
Mean (SD) 2.9 (1.62) 3.7 (1.78)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Any systemic eventceventb
nbna 985984 751749
Mean (SD) 2.2 (1. 3637) 2.6 (1. 6465)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
nbna 382 224
Mean (SD) 2.6 (1.48) 3.2 (1.90)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
2 FeveraFever (≥38.0°C)
nbna 224219 4
Mean (SD) 2.0 (0.3534) 4.3 (2.50)
Median 2.0 4.5
Min, max (1, 6) (1, 7)
Fatigue
nbna 952949 307306
Mean (SD) 2.0 (0.95) 2.8 (1.78)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nbna 742733 259
Mean (SD) 2.2 (1.12) 2.9 (1.87)
Median 2.0 2.0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Min, max (1, 7) (1, 7)
Chills
nbna 440435 57
Mean (SD) 2.0 (0.60) 3.0 (1.88)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Vomiting
nbna 13 5
Mean (SD) 3.2 (2.05 3 (1.97 ) 4.2 (1.79)
Median 2.0 4.0
Min, max (12, 7) (2, 7)
Diarrhea
nbna 154152 103102
Mean (SD) 3.4 (1. 7270) 3.5 (1. 5352)
Median 3.0 3.0
Min, max (1, 7) (1, 7)
New or worsened muscle pain
nbna 540537 99
Mean (SD) 2.1 (0.88) 3.1 (1.72)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
New or worsened joint pain
nbna 355353 72
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) –
Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Age Group Dose Systemic Event BNT162b2 (30 μg) Placebo
Mean (SD) 2.2 (0.98) 3.5 (1.88)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Any systemic eventceventb
nbna 1214 1203 518516
Mean (SD) 2.0 (0.96) 2.7 (1.73)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
nbna 688 170
Mean (SD) 2.1 (0.93) 3.4 (1.95)
Median 2.0 3.0
Min, max (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.
cb. Any systemic event: any fever ≥38.0°C , any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any
new or worsened joint pain.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:22 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s060 se onset p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Ye ars of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
1 FeveraFever (≥38.0°C)
nbna 21 4
Mean (SD) 2.0 (0.00NE) 2.5 (2.38)
Median 2.0 1.5
Min, max (2, 2) (1, 6)
Fatigue
nbna 22 15
Mean (SD) 1.9 (0.71) 2.8 (1.97)
Median 2.0 2.0
Min, max (1, 4) (1, 7)
Headache
nbna 11 18
Mean (SD) 2.0 (1.34) 2.6 (1.98)
Median 1.0 1.5
Min, max (1, 4) (1, 7)
Chills
nbna 6 5
Mean (SD) 2.2 (1.8 (0.75 17) 2.2 (2.68)
Median 2.0 1.0
Min, max (1, 34) (1, 7)
Vomiting
nbna 1 3
Mean (SD) 3.0 (NE) 2.0 (1.00)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Ye ars of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Median 3.0 2.0
Min, max (3, 3) (1, 3)
Diarrhea
nbna 5 8
Mean (SD) 4.0 (2.24) 4.0 (2.00)
Median 4.0 3.5
Min, max (1, 7) (2, 7)
New or worsened muscle pain
nbna 109 10
Mean (SD) 3.3 (1.95 2 (2.05 ) 2.23 (1.4034)
Median 2.50 2.0
Min, max (1, 7) (1, 5)
New or worsened joint pain
nbna 5 7
Mean (SD) 2.8 (1.79) 3.0 (2.16)
Median 2.0 2.0
Min, max (2, 6) (1, 7)
Any systemic eventceventb
nbna 3332 32
Mean (SD) 2.0 (1. 3840) 2.6 (1.76)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Ye ars of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
nbna 7 8
Mean (SD) 2.1 (0.38) 2.3 (1.49)
Median 2.0 2.0
Min, max (2, 3) (1, 5)
2 FeveraFever (≥38.0°C)
nbna 139 5
Mean (SD) 2.26 (1.5974) 3.8 (2.39)
Median 2.0 4.0
Min, max (1, 7) (1, 7)
Fatigue
nbna 2624 1312
Mean (SD) 2.23 (1.3940) 2.23 (1.3637)
Median 2.0 2.0
Min, max (1, 7) (1, 6)
Headache
nbna 1918 12
Mean (SD) 2.56 (1.6169) 3.9 (2.31)
Median 2.0 4.0
Min, max (1, 7) (1, 7)
Chills
nbna 1614 4
Mean (SD) 2.69 (1.6361) 4.3 (2.63)
Median 2.0 4.0
Min, max (12, 7) (2, 7)
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Ye ars of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Vomiting
nbna 2 2
Mean (SD) 1.5 (0 (0.00 .71) 2.0 (1.41)
Median 1.05 2.0
Min, max (1, 12) (1, 3)
Diarrhea
nbna 4 9
Mean (SD) 3.8 (2.50) 3.1 (1.96)
Median 3.5 3.0
Min, max (1, 7) (1, 7)
New or worsened muscle pain
nbna 1210 5
Mean (SD) 1.89 (0.6257) 3.8 (2.49)
Median 2.0 2.0
Min, max (1, 3) (2, 7)
New or worsened joint pain
nbna 1110 5
Mean (SD) 3.01 (2.1423) 4.6 (2.07)
Median 2.0 5.0
Min, max (1, 7) (2, 7)
Any systemic eventceventb
nbna 3936 2423
Mean (SD) 2.45 (1.6063) 2.2 (1 (1.36 .37)
Median 2.0 2.0
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Ye ars of Age – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Min, max (1, 7) (1, 5)
Use of antipyretic or pain medication
nbna 16 7
Mean (SD) 2.6 (1.71) 4.1 (2.12)
Median 2.0 5.0
Min, max (1, 7) (2, 7)
Abbreviations: HIV = human immunodeficiency virus; NE = not estimable.
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.
cb. Any systemic event: any fever ≥38.0°C , any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any
new or worsened joint pain.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 ( 25MAR2021 (19: 22:11) Source Data: adfacevd Table Generation: 29APR2021
(23:22 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY BLA /adce s060 se onset hiv p3 saf
090177e196f19a0b\Final\Final On: 04-May-2021 06:41 (GMT)