Document text
E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ............................................................................. 3
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 ................................................................................................................................................ 5
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 ........................................................................................................................................................................................................................ 14
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 ............................................................................................................................................................ 20
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 .................................................................................................................................................................................................................................... 22
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 .............................................................................................................................................................................................................. 25
Onset Days for Local Reactions, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ................................... 27
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 .............................................................................................................................................. 31
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 ........................................................................................................................................................................................ 39
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 ........................................................................................................................................................................................................................ 54
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 ............................................................................................................................................................ 69
Duration (Days) From First to Last Day of Systemic Events, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety
Populatio n .................................................................................................................................................................................................................................... 74
Onset Days for Systemic Events (Reactogenicity Subset) – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Su bjects ≥16 Years of
Age – Safety Population .............................................................................................................................................................................................................. 84
Onset Days for Systemic Events, by Age Group (Reactogenicity Subset) – Phase 2/3 Subje cts ≥16 Years of Age – Safety Population .................................. 89
Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) – All Subjects ≥16 Years of Age – Safety Population .............................................. 98
Listing of Severe and Grade 4 Local Reactions – Subjects Enrolled in Multiple Sites ............................................................................................................. 113
Listing of Severe and Grade 4 Local Reactions – Subjects With Indeterminate Vaccine – All Subjects ≥16 Years of Age .................................................... 114
Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) – All Subjects ≥16 Years of Age – Safety Population ............................................ 115
Listing of Severe and Grade 4 Systemic Events – Subjects Enrolled in Multiple Sites ............................................................................................................ 175
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0023998
Listing of Severe and Grade 4 Systemic Events – Subjects With Indeterminate Vaccine – All Subjects ≥16 Years of Age .................................................... 176
Subjects Reporting 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 .............................................................................................................. 177
Subjects Reporting 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 ...................................................................................................................................................................................... 178
Subjec ts Reporting 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 .............................................................................................................. 179
Subjects Reporting 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 ...................................................................................................................................................................................... 180
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0023999
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)
All 7 dayse 2718 (54.8) 2481 (50.3)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024000
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 (%)
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 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 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinde d/C4591001_sBLA_CBER_EDIARY/adce_s200_trns_p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024001
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 55 3 (5.5) (1.1, 15.1) 56 3 (5.4) (1.1, 14.9)
Mild 55 3 (5.5) (1.1, 15.1) 56 1 (1.8) (0.0, 9.6)
Moderate 55 0 (0.0, 6.5) 56 0 (0.0, 6.4)
Severe 55 0 (0.0, 6.5) 56 2 (3.6) (0.4, 12.3)
Grade 4 55 0 (0.0, 6.5) 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 57 38 (66.7) (52.9, 78.6) 56 9 (16.1) (7.6, 28.3)
Mild 57 30 (52.6) (39.0, 66.0) 56 8 (14.3) (6.4, 26.2)
Moderate 57 8 (14.0) (6.3, 25.8) 56 1 (1.8) (0.0, 9.6)
Severe 57 0 (0.0, 6.3) 56 0 (0.0, 6.4)
Grade 4 57 0 (0.0, 6.3) 56 0 (0.0, 6.4)
Any local reactionf 57 39 (68.4) (54.8, 80.1) 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)
Mild 60 3 (5.0) (1.0, 13.9) 62 1 (1.6) (0.0, 8.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024002
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)
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 61 33 (54.1) (40.8, 66.9) 62 5 (8.1) (2.7, 17.8)
Mild 61 23 (37.7) (25.6, 51.0) 62 5 (8.1) (2.7, 17.8)
Moderate 61 9 (14.8) (7.0, 26.2) 62 0 (0.0, 5.8)
Severe 61 1 (1.6) (0.0, 8.8) 62 0 (0.0, 5.8)
Grade 4 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
Any local reactionf 61 33 (54.1) (40.8, 66.9) 62 5 (8.1) (2.7, 17.8)
Any dose Rednessd
Any 73 6 (8.2) (3.1, 17.0) 74 3 (4.1) (0.8, 11.4)
Mild 73 5 (6.8) (2.3, 15.3) 74 1 (1.4) (0.0, 7.3)
Moderate 73 1 (1.4) (0.0, 7.4) 74 0 (0.0, 4.9)
Severe 73 0 (0.0, 4.9) 74 2 (2.7) (0.3, 9.4)
Grade 4 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024003
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 74 54 (73.0) (61.4, 82.6) 74 12 (16.2) (8.7, 26.6)
Mild 74 40 (54.1) (42.1, 65.7) 74 11 (14.9) (7.7, 25.0)
Moderate 74 13 (17.6) (9.7, 28.2) 74 1 (1.4) (0.0, 7.3)
Severe 74 1 (1.4) (0.0, 7.3) 74 0 (0.0, 4.9)
Grade 4 74 0 (0.0, 4.9) 74 0 (0.0, 4.9)
Any local reactionf 74 54 (73.0) (61.4, 82.6) 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 s pecified characteristic.
c. Exact 2 -sided CI based on the Clopper and Pearson method.
d. Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exf oliative dermatitis
(redness cate gory only).
e. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: 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 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unbli nded/C4591001 sBLA CBER EDIARY/adce s010 lr hiv p3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024004
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)
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024005
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)
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)
Pain at the injection sitee
Any 154 94 (61.0) (52.9, 68.8) 165 11 (6.7) (3.4, 11.6)
Mild 154 54 (35.1) (27.6, 43.2) 165 9 (5.5) (2.5, 10.1)
Moderate 154 34 (22.1) (15.8, 29.5) 165 2 (1.2) (0.1, 4.3)
Severe 154 6 (3.9) (1.4, 8.3) 165 0 (0.0, 2.2)
Grade 4 154 0 (0.0, 2.4) 165 0 (0.0, 2.2)
Any local reactionf 154 96 (62.3) (54.2, 70.0) 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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024006
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)
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)
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 255 (5.4) (4.8, 6.1) 4690 46 (1.0) (0.7, 1.3)
Mild 4701 183 (3.9) (3.4, 4.5) 4690 33 (0.7) (0.5, 1.0)
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 310 (6.6) (5.9, 7.3) 4690 40 (0.9) (0.6, 1.2)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024007
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)
Mild 4701 204 (4.3) (3.8, 5.0) 4690 19 (0.4) (0.2, 0.6)
Moderate 4701 99 (2.1) (1.7, 2.6) 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)
Pain at the injection sitee
Any 4702 3685 (78.4) (77.2, 79.5) 4690 579 (12.3) (11.4, 13.3)
Mild 4702 2487 (52.9) (51.5, 54.3) 4690 552 (11.8) (10.9, 12.7)
Moderate 4702 1159 (24.6) (23.4, 25.9) 4690 25 (0.5) (0.3, 0.8)
Severe 4702 39 (0.8) (0.6, 1.1) 4690 2 (0.0) (0.0, 0.2)
Grade 4 4702 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Any local reactionf 4702 3725 (79.2) (78.0, 80.4) 4690 620 (13.2) (12.3, 14.2)
2 Rednessd
Any 4369 279 (6.4) (5.7, 7.2) 4334 31 (0.7) (0.5, 1.0)
Mild 4369 149 (3.4) (2.9, 4.0) 4334 22 (0.5) (0.3, 0.8)
Moderate 4369 109 (2.5) (2.1, 3.0) 4334 9 (0.2) (0.1, 0.4)
Severe 4369 21 (0.5) (0.3, 0.7) 4334 0 (0.0, 0.1)
Grade 4 4369 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
Swellingd
Any 4369 320 (7.3) (6.6, 8.1) 4334 17 (0.4) (0.2, 0.6)
Mild 4369 187 (4.3) (3.7, 4.9) 4334 7 (0.2) (0.1, 0.3)
Moderate 4369 122 (2.8) (2.3, 3.3) 4334 9 (0.2) (0.1, 0.4)
Severe 4369 11 (0.3) (0.1, 0.5) 4334 1 (0.0) (0.0, 0.1)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024008
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)
Grade 4 4369 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
Pain at the injection sitee
Any 4379 3238 (73.9) (72.6, 75.2) 4336 450 (10.4) (9.5, 11.3)
Mild 4379 2096 (47.9) (46.4, 49.4) 4336 419 (9.7) (8.8, 10.6)
Moderate 4379 1099 (25.1) (23.8, 26.4) 4336 31 (0.7) (0.5, 1.0)
Severe 4379 43 (1.0) (0.7, 1.3) 4336 0 (0.0, 0.1)
Grade 4 4379 0 (0.0, 0.1) 4336 0 (0.0, 0.1)
Any local reactionf 4379 3255 (74.3) (73.0, 75.6) 4336 477 (11.0) (10.1, 12.0)
Any dose Rednessd
Any 4718 472 (10.0) (9.2, 10.9) 4708 70 (1.5) (1.2, 1.9)
Mild 4718 291 (6.2) (5.5, 6.9) 4708 48 (1.0) (0.8, 1.3)
Moderate 4718 150 (3.2) (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 527 (11.2) (10.3, 12.1) 4708 51 (1.1) (0.8, 1.4)
Mild 4718 321 (6.8) (6.1, 7.6) 4708 22 (0.5) (0.3, 0.7)
Moderate 4718 188 (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)
Pain at the injection sitee
Any 4718 3992 (84.6) (83.6, 85.6) 4708 826 (17.5) (16.5, 18.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024009
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)
Mild 4718 2275 (48.2) (46.8, 49.7) 4708 772 (16.4) (15.4, 17.5)
Moderate 4718 1639 (34.7) (33.4, 36.1) 4708 52 (1.1) (0.8, 1.4)
Severe 4718 78 (1.7) (1.3, 2.1) 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 (85.2) (84.2, 86.2) 4708 880 (18.7) (17.6, 19.8)
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 = p ositive 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 w ere 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; G rade 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: emergency room visit or
hosp italization 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 (22:11) Source Data: adfacevd Table Generation: 29APR 2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 sBLA CBER EDIARY/adce s010 lr base p3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024010
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 158 (5.5) (4.7, 6.3) 2908 30 (1.0) (0.7, 1.5)
Mild 2899 115 (4.0) (3.3, 4.7) 2908 21 (0.7) (0.4, 1.1)
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 185 (6.4) (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 55 (1.9) (1.4, 2.5) 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 2428 (83.7) (82.3, 85.1) 2908 418 (14.4) (13.1, 15.7)
Mild 2900 1464 (50.5) (48.6, 52.3) 2908 395 (13.6) (12.4, 14.9)
Moderate 2900 924 (31.9) (30.2, 33.6) 2908 20 (0.7) (0.4, 1.1)
Severe 2900 40 (1.4) (1.0, 1.9) 2908 3 (0.1) (0.0, 0.3)
Grade 4 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Any local reactionf 2900 2446 (84.3) (83.0, 85.6) 2908 438 (15.1) (13.8, 16.4)
2 Rednessd
Any 2683 152 (5.7) (4.8, 6.6) 2684 18 (0.7) (0.4, 1.1)
Mild 2683 90 (3.4) (2.7, 4.1) 2684 12 (0.4) (0.2, 0.8)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024011
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)
Moderate 2683 51 (1.9) (1.4, 2.5) 2684 6 (0.2) (0.1, 0.5)
Severe 2683 11 (0.4) (0.2, 0.7) 2684 0 (0.0, 0.1)
Grade 4 2683 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Swellingd
Any 2683 185 (6.9) (6.0, 7.9) 2684 5 (0.2) (0.1, 0.4)
Mild 2683 112 (4.2) (3.4, 5.0) 2684 3 (0.1) (0.0, 0.3)
Moderate 2683 66 (2.5) (1.9, 3.1) 2684 2 (0.1) (0.0, 0.3)
Severe 2683 7 (0.3) (0.1, 0.5) 2684 0 (0.0, 0.1)
Grade 4 2683 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Pain at the injection sitee
Any 2691 2110 (78.4) (76.8, 80.0) 2684 315 (11.7) (10.5, 13.0)
Mild 2691 1280 (47.6) (45.7, 49.5) 2684 287 (10.7) (9.5, 11.9)
Moderate 2691 791 (29.4) (27.7, 31.2) 2684 28 (1.0) (0.7, 1.5)
Severe 2691 39 (1.4) (1.0, 2.0) 2684 0 (0.0, 0.1)
Grade 4 2691 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Any local reactionf 2691 2117 (78.7) (77.1, 80.2) 2684 328 (12.2) (11.0, 13.5)
Any dose Rednessd
Any 2909 278 (9.6) (8.5, 10.7) 2921 44 (1.5) (1.1, 2.0)
Mild 2909 181 (6.2) (5.4, 7.2) 2921 29 (1.0) (0.7, 1.4)
Moderate 2909 79 (2.7) (2.2, 3.4) 2921 12 (0.4) (0.2, 0.7)
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024012
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)
Swellingd
Any 2909 312 (10.7) (9.6, 11.9) 2921 20 (0.7) (0.4, 1.1)
Mild 2909 197 (6.8) (5.9, 7.7) 2921 9 (0.3) (0.1, 0.6)
Moderate 2909 102 (3.5) (2.9, 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 (88.7) (87.4, 89.8) 2921 590 (20.2) (18.8, 21.7)
Mild 2909 1279 (44.0) (42.2, 45.8) 2921 543 (18.6) (17.2, 20.0)
Moderate 2909 1225 (42.1) (40.3, 43.9) 2921 44 (1.5) (1.1, 2.0)
Severe 2909 75 (2.6) (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 (89.1) (87.9, 90.2) 2921 615 (21.1) (19.6, 22.6)
>55 Years 1 Rednessd
Any 2008 109 (5.4) (4.5, 6.5) 1989 21 (1.1) (0.7, 1.6)
Mild 2008 74 (3.7) (2.9, 4.6) 1989 14 (0.7) (0.4, 1.2)
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
Any 2008 142 (7.1) (6.0, 8.3) 1989 25 (1.3) (0.8, 1.8)
Mild 2008 88 (4.4) (3.5, 5.4) 1989 13 (0.7) (0.3, 1.1)
Moderate 2008 52 (2.6) (1.9, 3.4) 1989 12 (0.6) (0.3, 1.1)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024013
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 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 (70.2) (68.1, 72.2) 1989 187 (9.4) (8.2, 10.8)
Mild 2008 1109 (55.2) (53.0, 57.4) 1989 179 (9.0) (7.8, 10.3)
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 (71.5) (69.4, 73.4) 1989 210 (10.6) (9.2, 12.0)
2 Rednessd
Any 1860 134 (7.2) (6.1, 8.5) 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 59 (3.2) (2.4, 4.1) 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)
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
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024014
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 1863 1236 (66.3) (64.1, 68.5) 1835 147 (8.0) (6.8, 9.3)
Mild 1863 879 (47.2) (44.9, 49.5) 1835 142 (7.7) (6.6, 9.1)
Moderate 1863 347 (18.6) (16.9, 20.5) 1835 5 (0.3) (0.1, 0.6)
Severe 1863 10 (0.5) (0.3, 1.0) 1835 0 (0.0, 0.2)
Grade 4 1863 0 (0.0, 0.2) 1835 0 (0.0, 0.2)
Any local reactionf 1863 1248 (67.0) (64.8, 69.1) 1835 162 (8.8) (7.6, 10.2)
Any dose Rednessd
Any 2015 213 (10.6) (9.3, 12.0) 1994 31 (1.6) (1.1, 2.2)
Mild 2015 122 (6.1) (5.1, 7.2) 1994 21 (1.1) (0.7, 1.6)
Moderate 2015 76 (3.8) (3.0, 4.7) 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 238 (11.8) (10.4, 13.3) 1994 33 (1.7) (1.1, 2.3)
Mild 2015 135 (6.7) (5.6, 7.9) 1994 14 (0.7) (0.4, 1.2)
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)
Pain at the injection sitee
Any 2015 1579 (78.4) (76.5, 80.1) 1994 269 (13.5) (12.0, 15.1)
Mild 2015 1079 (53.5) (51.3, 55.7) 1994 256 (12.8) (11.4, 14.4)
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024015
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)
Grade 4 2015 0 (0.0, 0.2) 1994 0 (0.0, 0.2)
Any local reactionf 2015 1599 (79.4) (77.5, 81.1) 1994 300 (15.0) (13.5, 16.7)
Note: Reactions were collected in the electronic diary (e -diary) from Day 1 through Day 7 after each dose.
Note: Grade 4 reactions were classified by the investigator or medically qualified person.
a. N = number of subjects reporting at least 1 yes or no response for the specified reaction after the specified dose.
b. n = Number of subjects with the s pecified characteristic.
c. Exact 2 -sided CI based on the Clopper and Pearson method.
d. Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exf oliative dermatitis
(redness cate gory only).
e. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: 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 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unbli nded/C4591001 sBLA CBER EDIARY/adce s010 lr p3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024016
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 Adm inistered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
1 Redness
na 3 3
Mean (SD) 1.7 (0.58) 1.0 (0.00)
Median 2.0 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 38 9
Mean (SD) 2.0 (1.14) 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
Mean (SD) 1.8 (0.84) NE (NE)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024017
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 Adm inistered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
Median 2.0 NE
Min, max (1, 3) (NE, NE)
Pain at the injection site
na 33 5
Mean (SD) 1.9 (1.17) 2.0 (1.41)
Median 1.0 1.0
Min, max (1, 5) (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 subject s reporting the specified reaction on any of the 7 days, including subjects with reactions of unknown duration.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:06) Source Data: adcevd Table Generation: 29APR2021 (23:34)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_s030_lr_dur_hiv_p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024018
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 158 30
Mean (SD) 2.3 (1.99) 1.7 (1.35)
Median 1.5 1.0
Min, max (1, 14) (1, 6)
Swelling
na 185 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 418
Mean (SD) 2.2 (1.49) 1.5 (1.50)
Median 2.0 1.0
Min, max (1, 22) (1, 17)
Unknownb 2 1
2 Redness
na 152 18
Mean (SD) 2.2 (1.60) 1.2 (0.43)
Median 2.0 1.0
Min, max (1, 9) (1, 2)
Swelling
na 185 5
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024019
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 (1.49) 2.2 (0.84)
Median 2.0 2.0
Min, max (1, 8) (1, 3)
Pain at the injection site
na 2110 315
Mean (SD) 2.5 (2.20) 1.9 (2.82)
Median 2.0 1.0
Min, max (1, 70) (1, 35)
Unknownb 5 0
>55 Years 1 Redness
na 109 21
Mean (SD) 2.4 (2.36) 1.9 (2.06)
Median 2.0 1.0
Min, max (1, 20) (1, 10)
Swelling
na 142 25
Mean (SD) 1.7 (1.03) 2.8 (2.84)
Median 1.0 1.0
Min, max (1, 6) (1, 11)
Pain at the injection site
na 1409 187
Mean (SD) 1.9 (1.46) 1.8 (2.15)
Median 2.0 1.0
Min, max (1, 22) (1, 19)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024020
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 134 14
Mean (SD) 3.0 (3.91) 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 (1.28)
Median 2.0 1.0
Min, max (1, 34) (1, 5)
Pain at the injection site
na 1236 147
Mean (SD) 2.4 (1.98) 1.9 (2.65)
Median 2.0 1.0
Min, max (1, 36) (1, 30)
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 (22:06) Source D ata: adcevd Table Generation: 29APR2021 (23:34)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 sBLA CBER EDIARY/adce s030 lr dur p 3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024021
Onset Days for Local Reactions (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HI V-Positive Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
Dose Local Reaction BNT162b2 (30 μg) Placebo
1 Redness
na 3 3
Mean (SD) 1.7 (0.58) 1.0 (0.00)
Median 2.0 1.0
Min, max (1, 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 38 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 39 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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024022
Onset Days for Local Reactions (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HI V-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 33 5
Mean (SD) 1.5 (0.67) 1.6 (0.89)
Median 1.0 1.0
Min, max (1, 3) (1, 3)
Any local reactionb
na 33 5
Mean (SD) 1.5 (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 reacti on.
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 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:22)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_s050_lr_onset_hiv_p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024023
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 158 30
Mean (SD) 2.3 (0.98) 1.8 (1.27)
Median 2.0 1.0
Min, max (1, 7) (1, 5)
Swelling
na 185 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 418
Mean (SD) 1.4 (0.55) 1.6 (1.15)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
Any local reactionb
na 2446 438
Mean (SD) 1.4 (0.55) 1.6 (1.14)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
2 Redness
na 152 18
Mean (SD) 2.5 (0.98) 2.2 (1.50)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024024
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 185 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 315
Mean (SD) 1.4 (0.59) 1.4 (0.95)
Median 1.0 1.0
Min, max (1, 6) (1, 7)
Any local reactionb
na 2117 328
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 109 21
Mean (SD) 2.3 (0.82) 1.6 (0.51)
Median 2.0 2.0
Min, max (1, 5) (1, 2)
Swelling
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024025
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 142 25
Mean (SD) 1.9 (0.58) 1.5 (0.87)
Median 2.0 1.0
Min, max (1, 4) (1, 4)
Pain at the injection site
na 1409 187
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 210
Mean (SD) 1.6 (0.53) 1.8 (1.14)
Median 2.0 1.0
Min, max (1, 5) (1, 7)
2 Redness
na 134 14
Mean (SD) 2.7 (1.04) 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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024026
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 147
Mean (SD) 1.5 (0.68) 1.7 (1.18)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
Any local reactionb
na 1248 162
Mean (SD) 1.5 (0.66) 1.7 (1.21)
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 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:22)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_s050_lr_onset _p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024027
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 54 2 (3.7) (0.5, 12.7) 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)
Fatiguee
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)
Headachee
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)
Chillse
Any 54 6 (11.1) (4.2, 22.6) 56 5 (8.9) (3.0, 19.6)
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024028
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)
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)
Vomitingf
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)
Diarrheag
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 paine
Any 55 10 (18.2) (9.1, 30.9) 56 10 (17.9) (8.9, 30.4)
Mild 55 7 (12.7) (5.3, 24.5) 56 7 (12.5) (5.2, 24.1)
Moderate 55 3 (5.5) (1.1, 15.1) 56 3 (5.4) (1.1, 14.9)
Severe 55 0 (0.0, 6.5) 56 0 (0.0, 6.4)
Grade 4 55 0 (0.0, 6.5) 56 0 (0.0, 6.4)
New or worsened joint paine
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024029
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)
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 eventh 55 33 (60.0) (45.9, 73.0) 56 32 (57.1) (43.2, 70.3)
Use of antipyretic or pain medicationi 54 7 (13.0) (5.4, 24.9) 56 8 (14.3) (6.4, 26.2)
2 Fever
Any 61 13 (21.3) (11.9, 33.7) 62 5 (8.1) (2.7, 17.8)
≥38.0°C to 38.4°C 61 4 (6.6) (1.8, 15.9) 62 5 (8.1) (2.7, 17.8)
>38.4°C to 38.9°C 61 4 (6.6) (1.8, 15.9) 62 0 (0.0, 5.8)
>38.9°C to 40.0°C 61 1 (1.6) (0.0, 8.8) 62 0 (0.0, 5.8)
>40.0°C 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
Unknownd 61 4 (6.6) (1.8, 15.9) 62 0 (0.0, 5.8)
Fatiguee
Any 62 26 (41.9) (29.5, 55.2) 63 13 (20.6) (11.5, 32.7)
Mild 62 14 (22.6) (12.9, 35.0) 63 6 (9.5) (3.6, 19.6)
Moderate 62 9 (14.5) (6.9, 25.8) 63 7 (11.1) (4.6, 21.6)
Severe 62 3 (4.8) (1.0, 13.5) 63 0 (0.0, 5.7)
Grade 4 62 0 (0.0, 5.8) 63 0 (0.0, 5.7)
Headachee
Any 61 19 (31.1) (19.9, 44.3) 62 12 (19.4) (10.4, 31.4)
Mild 61 9 (14.8) (7.0, 26.2) 62 8 (12.9) (5.7, 23.9)
Moderate 61 8 (13.1) (5.8, 24.2) 62 4 (6.5) (1.8, 15.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024030
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)
Severe 61 2 (3.3) (0.4, 11.3) 62 0 (0.0, 5.8)
Grade 4 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
Chillse
Any 61 16 (26.2) (15.8, 39.1) 62 4 (6.5) (1.8, 15.7)
Mild 61 6 (9.8) (3.7, 20.2) 62 3 (4.8) (1.0, 13.5)
Moderate 61 8 (13.1) (5.8, 24.2) 62 1 (1.6) (0.0, 8.7)
Severe 61 2 (3.3) (0.4, 11.3) 62 0 (0.0, 5.8)
Grade 4 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
Vomitingf
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 0 (0.0, 6.0) 62 1 (1.6) (0.0, 8.7)
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)
Diarrheag
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 paine
Any 61 12 (19.7) (10.6, 31.8) 62 5 (8.1) (2.7, 17.8)
Mild 61 7 (11.5) (4.7, 22.2) 62 1 (1.6) (0.0, 8.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024031
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)
Moderate 61 4 (6.6) (1.8, 15.9) 62 4 (6.5) (1.8, 15.7)
Severe 61 1 (1.6) (0.0, 8.8) 62 0 (0.0, 5.8)
Grade 4 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
New or worsened joint paine
Any 61 11 (18.0) (9.4, 30.0) 62 5 (8.1) (2.7, 17.8)
Mild 61 5 (8.2) (2.7, 18.1) 62 1 (1.6) (0.0, 8.7)
Moderate 61 6 (9.8) (3.7, 20.2) 62 4 (6.5) (1.8, 15.7)
Severe 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
Grade 4 61 0 (0.0, 5.9) 62 0 (0.0, 5.8)
Any systemic eventh 62 39 (62.9) (49.7, 74.8) 63 24 (38.1) (26.1, 51.2)
Use of antipyretic or pain medicationi 60 16 (26.7) (16.1, 39.7) 62 7 (11.3) (4.7, 21.9)
Any dose Fever
Any 73 14 (19.2) (10.9, 30.1) 74 7 (9.5) (3.9, 18.5)
≥38.0°C to 38.4°C 73 4 (5.5) (1.5, 13.4) 74 5 (6.8) (2.2, 15.1)
>38.4°C to 38.9°C 73 4 (5.5) (1.5, 13.4) 74 0 (0.0, 4.9)
>38.9°C to 40.0°C 73 1 (1.4) (0.0, 7.4) 74 2 (2.7) (0.3, 9.4)
>40.0°C 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
Unknownd 73 5 (6.8) (2.3, 15.3) 74 0 (0.0, 4.9)
Fatiguee
Any 74 36 (48.6) (36.9, 60.6) 75 21 (28.0) (18.2, 39.6)
Mild 74 20 (27.0) (17.4, 38.6) 75 9 (12.0) (5.6, 21.6)
Moderate 74 13 (17.6) (9.7, 28.2) 75 11 (14.7) (7.6, 24.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024032
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)
Severe 74 3 (4.1) (0.8, 11.4) 75 1 (1.3) (0.0, 7.2)
Grade 4 74 0 (0.0, 4.9) 75 0 (0.0, 4.8)
Headachee
Any 73 25 (34.2) (23.5, 46.3) 74 23 (31.1) (20.8, 42.9)
Mild 73 13 (17.8) (9.8, 28.5) 74 13 (17.6) (9.7, 28.2)
Moderate 73 10 (13.7) (6.8, 23.8) 74 9 (12.2) (5.7, 21.8)
Severe 73 2 (2.7) (0.3, 9.5) 74 1 (1.4) (0.0, 7.3)
Grade 4 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
Chillse
Any 73 19 (26.0) (16.5, 37.6) 74 9 (12.2) (5.7, 21.8)
Mild 73 8 (11.0) (4.9, 20.5) 74 7 (9.5) (3.9, 18.5)
Moderate 73 9 (12.3) (5.8, 22.1) 74 2 (2.7) (0.3, 9.4)
Severe 73 2 (2.7) (0.3, 9.5) 74 0 (0.0, 4.9)
Grade 4 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
Vomitingf
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 0 (0.0, 5.0) 74 0 (0.0, 4.9)
Severe 72 1 (1.4) (0.0, 7.5) 74 2 (2.7) (0.3, 9.4)
Grade 4 72 0 (0.0, 5.0) 74 0 (0.0, 4.9)
Diarrheag
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024033
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)
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 paine
Any 73 19 (26.0) (16.5, 37.6) 74 14 (18.9) (10.7, 29.7)
Mild 73 13 (17.8) (9.8, 28.5) 74 8 (10.8) (4.8, 20.2)
Moderate 73 5 (6.8) (2.3, 15.3) 74 6 (8.1) (3.0, 16.8)
Severe 73 1 (1.4) (0.0, 7.4) 74 0 (0.0, 4.9)
Grade 4 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
New or worsened joint paine
Any 73 14 (19.2) (10.9, 30.1) 74 11 (14.9) (7.7, 25.0)
Mild 73 8 (11.0) (4.9, 20.5) 74 5 (6.8) (2.2, 15.1)
Moderate 73 6 (8.2) (3.1, 17.0) 74 6 (8.1) (3.0, 16.8)
Severe 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
Grade 4 73 0 (0.0, 4.9) 74 0 (0.0, 4.9)
Any systemic eventh 74 52 (70.3) (58.5, 80.3) 75 40 (53.3) (41.4, 64.9)
Use of antipyretic or pain medicationi 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
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
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024034
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)
related fever measurements, are counted in this row.
e. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or
hospitalization for severe fatigue, severe headache, severe chills, severe muscle pain, or severe joint pain.
f. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or
hospitalization for severe vomiting.
g. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room
visit or hospitalization for severe diarrhea.
h. Any systemic event: any fever, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or
worsened joint pain.
i. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25 MAR2021) Output File: ./nda2 unblinded/C4591001 sBLA CBER EDIARY/adce s020 se hiv p3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024035
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 (a s 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 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)
Fatiguee
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)
Headachee
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)
Chillse
Any 177 49 (27.7) (21.2, 34.9) 187 8 (4.3) (1.9, 8.3)
Mild 177 33 (18.6) (13.2, 25.2) 187 5 (2.7) (0.9, 6.1)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024036
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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)
Vomitingf
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)
Diarrheag
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 paine
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)
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 paine
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024037
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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 eventh 177 115 (65.0) (57.5, 72.0) 187 77 (41.2) (34.0, 48.6)
Use of antipyretic or pain
medicationi 177 67 (37.9) (30.7, 45.4) 187 28 (15.0) (10.2, 20.9)
2 Fever
Any 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)
Fatiguee
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)
Headachee
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024038
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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)
Chillse
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)
Vomitingf
Any 153 2 (1.3) (0.2, 4.6) 165 4 (2.4) (0.7, 6.1)
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)
Diarrheag
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024039
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 153 0 (0.0, 2.4) 165 0 (0.0, 2.2)
New or worsened muscle paine
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 paine
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)
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 eventh 153 87 (56.9) (48.6, 64.8) 165 50 (30.3) (23.4, 37.9)
Use of antipyretic or pain
medicationi 153 48 (31.4) (24.1, 39.4) 165 16 (9.7) (5.6, 15.3)
Any dose Fever
Any 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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024040
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Unknownd 177 0 (0.0, 2.1) 187 0 (0.0, 2.0)
Fatiguee
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)
Headachee
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)
Chillse
Any 177 58 (32.8) (25.9, 40.2) 187 10 (5.3) (2.6, 9.6)
Mild 177 34 (19.2) (13.7, 25.8) 187 7 (3.7) (1.5, 7.6)
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)
Vomitingf
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024041
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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)
Diarrheag
Any 177 18 (10.2) (6.1, 15.6) 187 27 (14.4) (9.7, 20.3)
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 paine
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 paine
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 eventh 177 129 (72.9) (65.7, 79.3) 187 96 (51.3) (43.9, 58.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024042
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Use of antipyretic or pain
medicationi 177 77 (43.5) (36.1, 51.1) 187 38 (20.3) (14.8, 26.8)
Negative 1 Fever
Any 4701 123 (2.6) (2.2, 3.1) 4690 30 (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)
Fatiguee
Any 4702 2013 (42.8) (41.4, 44.2) 4690 1368 (29.2) (27.9, 30.5)
Mild 4702 1140 (24.2) (23.0, 25.5) 4690 829 (17.7) (16.6, 18.8)
Moderate 4702 832 (17.7) (16.6, 18.8) 4690 519 (11.1) (10.2, 12.0)
Severe 4702 41 (0.9) (0.6, 1.2) 4690 20 (0.4) (0.3, 0.7)
Grade 4 4702 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Headachee
Any 4703 1682 (35.8) (34.4, 37.2) 4692 1294 (27.6) (26.3, 28.9)
Mild 4703 1124 (23.9) (22.7, 25.1) 4692 867 (18.5) (17.4, 19.6)
Moderate 4703 527 (11.2) (10.3, 12.1) 4692 403 (8.6) (7.8, 9.4)
Severe 4703 31 (0.7) (0.4, 0.9) 4692 24 (0.5) (0.3, 0.8)
Grade 4 4703 0 (0.0, 0.1) 4692 0 (0.0, 0.1)
Chillse
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024043
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Any 4702 552 (11.7) (10.8, 12.7) 4690 260 (5.5) (4.9, 6.2)
Mild 4702 402 (8.5) (7.8, 9.4) 4690 192 (4.1) (3.5, 4.7)
Moderate 4702 138 (2.9) (2.5, 3.5) 4690 65 (1.4) (1.1, 1.8)
Severe 4702 12 (0.3) (0.1, 0.4) 4690 3 (0.1) (0.0, 0.2)
Grade 4 4702 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
Vomitingf
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)
Diarrheag
Any 4701 462 (9.8) (9.0, 10.7) 4691 441 (9.4) (8.6, 10.3)
Mild 4701 375 (8.0) (7.2, 8.8) 4691 364 (7.8) (7.0, 8.6)
Moderate 4701 80 (1.7) (1.4, 2.1) 4691 75 (1.6) (1.3, 2.0)
Severe 4701 7 (0.1) (0.1, 0.3) 4691 2 (0.0) (0.0, 0.2)
Grade 4 4701 0 (0.0, 0.1) 4691 0 (0.0, 0.1)
New or worsened muscle paine
Any 4702 878 (18.7) (17.6, 19.8) 4690 471 (10.0) (9.2, 10.9)
Mild 4702 517 (11.0) (10.1, 11.9) 4690 327 (7.0) (6.3, 7.7)
Moderate 4702 348 (7.4) (6.7, 8.2) 4690 139 (3.0) (2.5, 3.5)
Severe 4702 13 (0.3) (0.1, 0.5) 4690 5 (0.1) (0.0, 0.2)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024044
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 4702 0 (0.0, 0.1) 4690 0 (0.0, 0.1)
New or worsened joint paine
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 eventh 4703 2830 (60.2) (58.8, 61.6) 4692 2226 (47.4) (46.0, 48.9)
Use of antipyretic or pain
medicationi 4701 1109 (23.6) (22.4, 24.8) 4690 592 (12.6) (11.7, 13.6)
2 Fever
Any 4379 666 (15.2) (14.2, 16.3) 4335 15 (0.3) (0.2, 0.6)
≥38.0°C to 38.4°C 4379 399 (9.1) (8.3, 10.0) 4335 7 (0.2) (0.1, 0.3)
>38.4°C to 38.9°C 4379 199 (4.5) (3.9, 5.2) 4335 3 (0.1) (0.0, 0.2)
>38.9°C to 40.0°C 4379 46 (1.1) (0.8, 1.4) 4335 3 (0.1) (0.0, 0.2)
>40.0°C 4379 1 (0.0) (0.0, 0.1) 4335 0 (0.0, 0.1)
Unknownd 4379 21 (0.5) (0.3, 0.7) 4335 2 (0.0) (0.0, 0.2)
Fatiguee
Any 4378 2545 (58.1) (56.7, 59.6) 4335 893 (20.6) (19.4, 21.8)
Mild 4378 930 (21.2) (20.0, 22.5) 4335 493 (11.4) (10.4, 12.4)
Moderate 4378 1415 (32.3) (30.9, 33.7) 4335 385 (8.9) (8.1, 9.8)
Severe 4378 199 (4.5) (3.9, 5.2) 4335 15 (0.3) (0.2, 0.6)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024045
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 4378 1 (0.0) (0.0, 0.1) 4335 0 (0.0, 0.1)
Headachee
Any 4381 2135 (48.7) (47.2, 50.2) 4336 880 (20.3) (19.1, 21.5)
Mild 4381 1139 (26.0) (24.7, 27.3) 4336 579 (13.4) (12.4, 14.4)
Moderate 4381 896 (20.5) (19.3, 21.7) 4336 281 (6.5) (5.8, 7.3)
Severe 4381 100 (2.3) (1.9, 2.8) 4336 20 (0.5) (0.3, 0.7)
Grade 4 4381 0 (0.0, 0.1) 4336 0 (0.0, 0.1)
Chillse
Any 4378 1431 (32.7) (31.3, 34.1) 4334 169 (3.9) (3.3, 4.5)
Mild 4378 699 (16.0) (14.9, 17.1) 4334 133 (3.1) (2.6, 3.6)
Moderate 4378 642 (14.7) (13.6, 15.7) 4334 34 (0.8) (0.5, 1.1)
Severe 4378 90 (2.1) (1.7, 2.5) 4334 2 (0.0) (0.0, 0.2)
Grade 4 4378 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
Vomitingf
Any 4368 69 (1.6) (1.2, 2.0) 4334 31 (0.7) (0.5, 1.0)
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)
Diarrheag
Any 4368 412 (9.4) (8.6, 10.3) 4336 291 (6.7) (6.0, 7.5)
Mild 4368 338 (7.7) (7.0, 8.6) 4336 235 (5.4) (4.8, 6.1)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024046
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Moderate 4368 66 (1.5) (1.2, 1.9) 4336 53 (1.2) (0.9, 1.6)
Severe 4368 8 (0.2) (0.1, 0.4) 4336 3 (0.1) (0.0, 0.2)
Grade 4 4368 0 (0.0, 0.1) 4336 0 (0.0, 0.1)
New or worsened muscle paine
Any 4381 1565 (35.7) (34.3, 37.2) 4334 319 (7.4) (6.6, 8.2)
Mild 4381 663 (15.1) (14.1, 16.2) 4334 206 (4.8) (4.1, 5.4)
Moderate 4381 825 (18.8) (17.7, 20.0) 4334 109 (2.5) (2.1, 3.0)
Severe 4381 77 (1.8) (1.4, 2.2) 4334 4 (0.1) (0.0, 0.2)
Grade 4 4381 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
New or worsened joint paine
Any 4371 969 (22.2) (20.9, 23.4) 4334 209 (4.8) (4.2, 5.5)
Mild 4371 464 (10.6) (9.7, 11.6) 4334 118 (2.7) (2.3, 3.3)
Moderate 4371 469 (10.7) (9.8, 11.7) 4334 86 (2.0) (1.6, 2.4)
Severe 4371 36 (0.8) (0.6, 1.1) 4334 5 (0.1) (0.0, 0.3)
Grade 4 4371 0 (0.0, 0.1) 4334 0 (0.0, 0.1)
Any systemic eventh 4396 3171 (72.1) (70.8, 73.5) 4339 1493 (34.4) (33.0, 35.8)
Use of antipyretic or pain
medicationi 4368 1845 (42.2) (40.8, 43.7) 4334 470 (10.8) (9.9, 11.8)
Any dose Fever
Any 4718 736 (15.6) (14.6, 16.7) 4709 42 (0.9) (0.6, 1.2)
≥38.0°C to 38.4°C 4718 451 (9.6) (8.7, 10.4) 4709 24 (0.5) (0.3, 0.8)
>38.4°C to 38.9°C 4718 213 (4.5) (3.9, 5.1) 4709 9 (0.2) (0.1, 0.4)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024047
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
>38.9°C to 40.0°C 4718 49 (1.0) (0.8, 1.4) 4709 6 (0.1) (0.0, 0.3)
>40.0°C 4718 1 (0.0) (0.0, 0.1) 4709 0 (0.0, 0.1)
Unknownd 4718 22 (0.5) (0.3, 0.7) 4709 3 (0.1) (0.0, 0.2)
Fatiguee
Any 4718 3074 (65.2) (63.8, 66.5) 4708 1702 (36.2) (34.8, 37.5)
Mild 4718 1119 (23.7) (22.5, 25.0) 4708 931 (19.8) (18.6, 20.9)
Moderate 4718 1721 (36.5) (35.1, 37.9) 4708 740 (15.7) (14.7, 16.8)
Severe 4718 233 (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)
Headachee
Any 4718 2718 (57.6) (56.2, 59.0) 4710 1656 (35.2) (33.8, 36.5)
Mild 4718 1414 (30.0) (28.7, 31.3) 4710 1040 (22.1) (20.9, 23.3)
Moderate 4718 1179 (25.0) (23.8, 26.3) 4710 573 (12.2) (11.2, 13.1)
Severe 4718 125 (2.6) (2.2, 3.1) 4710 43 (0.9) (0.7, 1.2)
Grade 4 4718 0 (0.0, 0.1) 4710 0 (0.0, 0.1)
Chillse
Any 4718 1651 (35.0) (33.6, 36.4) 4708 370 (7.9) (7.1, 8.7)
Mild 4718 841 (17.8) (16.7, 18.9) 4708 279 (5.9) (5.3, 6.6)
Moderate 4718 710 (15.0) (14.0, 16.1) 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)
Vomitingf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024048
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
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)
Diarrheag
Any 4718 737 (15.6) (14.6, 16.7) 4709 633 (13.4) (12.5, 14.4)
Mild 4718 587 (12.4) (11.5, 13.4) 4709 507 (10.8) (9.9, 11.7)
Moderate 4718 135 (2.9) (2.4, 3.4) 4709 121 (2.6) (2.1, 3.1)
Severe 4718 15 (0.3) (0.2, 0.5) 4709 5 (0.1) (0.0, 0.2)
Grade 4 4718 0 (0.0, 0.1) 4709 0 (0.0, 0.1)
New or worsened muscle paine
Any 4718 1913 (40.5) (39.1, 42.0) 4708 658 (14.0) (13.0, 15.0)
Mild 4718 806 (17.1) (16.0, 18.2) 4708 423 (9.0) (8.2, 9.8)
Moderate 4718 1019 (21.6) (20.4, 22.8) 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 paine
Any 4718 1186 (25.1) (23.9, 26.4) 4708 422 (9.0) (8.2, 9.8)
Mild 4718 563 (11.9) (11.0, 12.9) 4708 246 (5.2) (4.6, 5.9)
Moderate 4718 581 (12.3) (11.4, 13.3) 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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024049
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 (a s Administered)
BNT162b2 (30 μg) Placebo
Baseline SARS -CoV -2
Status Dose Systemic Event Na nb (%) (95% CIc) Na nb (%) (95% CIc)
Grade 4 4718 0 (0.0, 0.1) 4708 0 (0.0, 0.1)
Any systemic eventh 4718 3734 (79.1) (78.0, 80.3) 4710 2613 (55.5) (54.0, 56.9)
Use of antipyretic or pain
medicationi 4718 2209 (46.8) (45.4, 48.3) 4708 881 (18.7) (17.6, 19.9)
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 = p ositive 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 l east 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. Mild: does not interfere with activity; moderate: some interference with activity; severe: pre vents daily activity; Grade 4: emergency room visit or
hospitalization for severe fatigue, severe headache, severe chills, severe muscle pain, or severe joint pain.
f. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or
hospitalization for severe vomiting.
g. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room
visit or hospitalization for severe diarrhea.
h. Any systemic event: any fever, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or
worsened joint pain.
i. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adc e_s020_se_base_p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024050
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
Any 2899 120 (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)
Fatiguee
Any 2900 1433 (49.4) (47.6, 51.3) 2908 960 (33.0) (31.3, 34.8)
Mild 2900 762 (26.3) (24.7, 27.9) 2908 570 (19.6) (18.2, 21.1)
Moderate 2900 630 (21.7) (20.2, 23.3) 2908 372 (12.8) (11.6, 14.1)
Severe 2900 41 (1.4) (1.0, 1.9) 2908 18 (0.6) (0.4, 1.0)
Grade 4 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Headachee
Any 2901 1264 (43.6) (41.8, 45.4) 2909 976 (33.6) (31.8, 35.3)
Mild 2901 787 (27.1) (25.5, 28.8) 2909 633 (21.8) (20.3, 23.3)
Moderate 2901 444 (15.3) (14.0, 16.7) 2909 319 (11.0) (9.9, 12.2)
Severe 2901 33 (1.1) (0.8, 1.6) 2909 24 (0.8) (0.5, 1.2)
Grade 4 2901 0 (0.0, 0.1) 2909 0 (0.0, 0.1)
Chillse
Any 2900 481 (16.6) (15.2, 18.0) 2908 200 (6.9) (6.0, 7.9)
Mild 2900 338 (11.7) (10.5, 12.9) 2908 149 (5.1) (4.4, 6.0)
Moderate 2900 128 (4.4) (3.7, 5.2) 2908 49 (1.7) (1.2, 2.2)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024051
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 2900 15 (0.5) (0.3, 0.9) 2908 2 (0.1) (0.0, 0.2)
Grade 4 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
Vomitingf
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)
Diarrheag
Any 2899 309 (10.7) (9.6, 11.8) 2908 324 (11.1) (10.0, 12.3)
Mild 2899 251 (8.7) (7.7, 9.7) 2908 265 (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 paine
Any 2900 667 (23.0) (21.5, 24.6) 2908 329 (11.3) (10.2, 12.5)
Mild 2900 355 (12.2) (11.1, 13.5) 2908 231 (7.9) (7.0, 9.0)
Moderate 2900 297 (10.2) (9.2, 11.4) 2908 96 (3.3) (2.7, 4.0)
Severe 2900 15 (0.5) (0.3, 0.9) 2908 2 (0.1) (0.0, 0.2)
Grade 4 2900 0 (0.0, 0.1) 2908 0 (0.0, 0.1)
New or worsened joint paine
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024052
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 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 eventh 2901 1983 (68.4) (66.6, 70.0) 2909 1560 (53.6) (51.8, 55.5)
Use of antipyretic or pain medicationi 2899 805 (27.8) (26.1, 29.4) 2908 398 (13.7) (12.5, 15.0)
2 Fever
Any 2691 456 (16.9) (15.5, 18.4) 2685 13 (0.5) (0.3, 0.8)
≥38.0°C to 38.4°C 2691 254 (9.4) (8.4, 10.6) 2685 5 (0.2) (0.1, 0.4)
>38.4°C to 38.9°C 2691 146 (5.4) (4.6, 6.3) 2685 4 (0.1) (0.0, 0.4)
>38.9°C to 40.0°C 2691 39 (1.4) (1.0, 2.0) 2685 2 (0.1) (0.0, 0.3)
>40.0°C 2691 1 (0.0) (0.0, 0.2) 2685 0 (0.0, 0.1)
Unknownd 2691 16 (0.6) (0.3, 1.0) 2685 2 (0.1) (0.0, 0.3)
Fatiguee
Any 2690 1659 (61.7) (59.8, 63.5) 2684 617 (23.0) (21.4, 24.6)
Mild 2690 563 (20.9) (19.4, 22.5) 2684 320 (11.9) (10.7, 13.2)
Moderate 2690 952 (35.4) (33.6, 37.2) 2684 283 (10.5) (9.4, 11.8)
Severe 2690 144 (5.4) (4.5, 6.3) 2684 14 (0.5) (0.3, 0.9)
Grade 4 2690 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Headachee
Any 2688 1456 (54.2) (52.3, 56.1) 2686 657 (24.5) (22.8, 26.1)
Mild 2688 704 (26.2) (24.5, 27.9) 2686 409 (15.2) (13.9, 16.6)
Moderate 2688 660 (24.6) (22.9, 26.2) 2686 230 (8.6) (7.5, 9.7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024053
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 2688 92 (3.4) (2.8, 4.2) 2686 18 (0.7) (0.4, 1.1)
Grade 4 2688 0 (0.0, 0.1) 2686 0 (0.0, 0.1)
Chillse
Any 2688 1024 (38.1) (36.3, 40.0) 2684 115 (4.3) (3.6, 5.1)
Mild 2688 482 (17.9) (16.5, 19.4) 2684 90 (3.4) (2.7, 4.1)
Moderate 2688 473 (17.6) (16.2, 19.1) 2684 23 (0.9) (0.5, 1.3)
Severe 2688 69 (2.6) (2.0, 3.2) 2684 2 (0.1) (0.0, 0.3)
Grade 4 2688 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
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)
Diarrheag
Any 2682 269 (10.0) (8.9, 11.2) 2685 206 (7.7) (6.7, 8.7)
Mild 2682 219 (8.2) (7.2, 9.3) 2685 170 (6.3) (5.4, 7.3)
Moderate 2682 44 (1.6) (1.2, 2.2) 2685 35 (1.3) (0.9, 1.8)
Severe 2682 6 (0.2) (0.1, 0.5) 2685 1 (0.0) (0.0, 0.2)
Grade 4 2682 0 (0.0, 0.1) 2685 0 (0.0, 0.1)
New or worsened muscle paine
Any 2692 1069 (39.7) (37.9, 41.6) 2684 237 (8.8) (7.8, 10.0)
Mild 2692 450 (16.7) (15.3, 18.2) 2684 150 (5.6) (4.7, 6.5)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024054
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 2692 557 (20.7) (19.2, 22.3) 2684 84 (3.1) (2.5, 3.9)
Severe 2692 62 (2.3) (1.8, 2.9) 2684 3 (0.1) (0.0, 0.3)
Grade 4 2692 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
New or worsened joint paine
Any 2684 643 (24.0) (22.4, 25.6) 2684 147 (5.5) (4.6, 6.4)
Mild 2684 293 (10.9) (9.8, 12.2) 2684 82 (3.1) (2.4, 3.8)
Moderate 2684 323 (12.0) (10.8, 13.3) 2684 61 (2.3) (1.7, 2.9)
Severe 2684 27 (1.0) (0.7, 1.5) 2684 4 (0.1) (0.0, 0.4)
Grade 4 2684 0 (0.0, 0.1) 2684 0 (0.0, 0.1)
Any systemic eventh 2702 2057 (76.1) (74.5, 77.7) 2687 1032 (38.4) (36.6, 40.3)
Use of antipyretic or pain medicationi 2682 1213 (45.2) (43.3, 47.1) 2684 320 (11.9) (10.7, 13.2)
Any dose Fever
Any 2909 533 (18.3) (16.9, 19.8) 2922 36 (1.2) (0.9, 1.7)
≥38.0°C to 38.4°C 2909 310 (10.7) (9.6, 11.8) 2922 20 (0.7) (0.4, 1.1)
>38.4°C to 38.9°C 2909 163 (5.6) (4.8, 6.5) 2922 9 (0.3) (0.1, 0.6)
>38.9°C to 40.0°C 2909 43 (1.5) (1.1, 2.0) 2922 5 (0.2) (0.1, 0.4)
>40.0°C 2909 1 (0.0) (0.0, 0.2) 2922 0 (0.0, 0.1)
Unknownd 2909 16 (0.6) (0.3, 0.9) 2922 2 (0.1) (0.0, 0.2)
Fatiguee
Any 2909 2042 (70.2) (68.5, 71.9) 2921 1172 (40.1) (38.3, 41.9)
Mild 2909 673 (23.1) (21.6, 24.7) 2921 615 (21.1) (19.6, 22.6)
Moderate 2909 1192 (41.0) (39.2, 42.8) 2921 529 (18.1) (16.7, 19.6)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024055
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 177 (6.1) (5.2, 7.0) 2921 28 (1.0) (0.6, 1.4)
Grade 4 2909 0 (0.0, 0.1) 2921 0 (0.0, 0.1)
Headachee
Any 2909 1893 (65.1) (63.3, 66.8) 2922 1229 (42.1) (40.3, 43.9)
Mild 2909 873 (30.0) (28.3, 31.7) 2922 733 (25.1) (23.5, 26.7)
Moderate 2909 901 (31.0) (29.3, 32.7) 2922 455 (15.6) (14.3, 16.9)
Severe 2909 119 (4.1) (3.4, 4.9) 2922 41 (1.4) (1.0, 1.9)
Grade 4 2909 0 (0.0, 0.1) 2922 0 (0.0, 0.1)
Chillse
Any 2909 1215 (41.8) (40.0, 43.6) 2921 272 (9.3) (8.3, 10.4)
Mild 2909 598 (20.6) (19.1, 22.1) 2921 207 (7.1) (6.2, 8.1)
Moderate 2909 535 (18.4) (17.0, 19.8) 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)
Vomitingf
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)
Diarrheag
Any 2909 492 (16.9) (15.6, 18.3) 2921 462 (15.8) (14.5, 17.2)
Mild 2909 393 (13.5) (12.3, 14.8) 2921 371 (12.7) (11.5, 14.0)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024056
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 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 paine
Any 2909 1335 (45.9) (44.1, 47.7) 2921 471 (16.1) (14.8, 17.5)
Mild 2909 534 (18.4) (17.0, 19.8) 2921 304 (10.4) (9.3, 11.6)
Moderate 2909 727 (25.0) (23.4, 26.6) 2921 162 (5.5) (4.7, 6.4)
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 paine
Any 2909 804 (27.6) (26.0, 29.3) 2921 272 (9.3) (8.3, 10.4)
Mild 2909 361 (12.4) (11.2, 13.7) 2921 161 (5.5) (4.7, 6.4)
Moderate 2909 411 (14.1) (12.9, 15.4) 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 eventh 2909 2451 (84.3) (82.9, 85.6) 2922 1798 (61.5) (59.7, 63.3)
Use of antipyretic or pain medicationi 2909 1485 (51.0) (49.2, 52.9) 2921 605 (20.7) (19.3, 22.2)
>55 Years 1 Fever
Any 2008 27 (1.3) (0.9, 2.0) 1989 9 (0.5) (0.2, 0.9)
≥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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024057
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 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)
Fatiguee
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)
Headachee
Any 2008 503 (25.0) (23.2, 27.0) 1990 365 (18.3) (16.7, 20.1)
Mild 2008 381 (19.0) (17.3, 20.8) 1990 269 (13.5) (12.0, 15.1)
Moderate 2008 120 (6.0) (5.0, 7.1) 1990 93 (4.7) (3.8, 5.7)
Severe 2008 2 (0.1) (0.0, 0.4) 1990 3 (0.2) (0.0, 0.4)
Grade 4 2008 0 (0.0, 0.2) 1990 0 (0.0, 0.2)
Chillse
Any 2008 131 (6.5) (5.5, 7.7) 1989 69 (3.5) (2.7, 4.4)
Mild 2008 103 (5.1) (4.2, 6.2) 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)
Vomitingf
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)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024058
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 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)
Grade 4 2008 0 (0.0, 0.2) 1989 0 (0.0, 0.2)
Diarrheag
Any 2008 168 (8.4) (7.2, 9.7) 1990 131 (6.6) (5.5, 7.8)
Mild 2008 137 (6.8) (5.8, 8.0) 1990 110 (5.5) (4.6, 6.6)
Moderate 2008 27 (1.3) (0.9, 2.0) 1990 20 (1.0) (0.6, 1.5)
Severe 2008 4 (0.2) (0.1, 0.5) 1990 1 (0.1) (0.0, 0.3)
Grade 4 2008 0 (0.0, 0.2) 1990 0 (0.0, 0.2)
New or worsened muscle paine
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 paine
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)
Any systemic eventh 2008 985 (49.1) (46.8, 51.3) 1990 751 (37.7) (35.6, 39.9)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024059
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)
Use of antipyretic or pain medicationi 2008 382 (19.0) (17.3, 20.8) 1989 224 (11.3) (9.9, 12.7)
2 Fever
Any 1862 224 (12.0) (10.6, 13.6) 1833 4 (0.2) (0.1, 0.6)
≥38.0°C to 38.4°C 1862 158 (8.5) (7.3, 9.8) 1833 2 (0.1) (0.0, 0.4)
>38.4°C to 38.9°C 1862 54 (2.9) (2.2, 3.8) 1833 1 (0.1) (0.0, 0.3)
>38.9°C to 40.0°C 1862 7 (0.4) (0.2, 0.8) 1833 1 (0.1) (0.0, 0.3)
>40.0°C 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)
Fatiguee
Any 1862 952 (51.1) (48.8, 53.4) 1834 307 (16.7) (15.1, 18.5)
Mild 1862 393 (21.1) (19.3, 23.0) 1834 184 (10.0) (8.7, 11.5)
Moderate 1862 498 (26.7) (24.7, 28.8) 1834 121 (6.6) (5.5, 7.8)
Severe 1862 60 (3.2) (2.5, 4.1) 1834 2 (0.1) (0.0, 0.4)
Grade 4 1862 1 (0.1) (0.0, 0.3) 1834 0 (0.0, 0.2)
Headachee
Any 1867 742 (39.7) (37.5, 42.0) 1833 259 (14.1) (12.6, 15.8)
Mild 1867 468 (25.1) (23.1, 27.1) 1833 189 (10.3) (9.0, 11.8)
Moderate 1867 261 (14.0) (12.4, 15.6) 1833 65 (3.5) (2.7, 4.5)
Severe 1867 13 (0.7) (0.4, 1.2) 1833 5 (0.3) (0.1, 0.6)
Grade 4 1867 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Chillse
Any 1864 440 (23.6) (21.7, 25.6) 1833 57 (3.1) (2.4, 4.0)
Mild 1864 233 (12.5) (11.0, 14.1) 1833 45 (2.5) (1.8, 3.3)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024060
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 1864 186 (10.0) (8.7, 11.4) 1833 12 (0.7) (0.3, 1.1)
Severe 1864 21 (1.1) (0.7, 1.7) 1833 0 (0.0, 0.2)
Grade 4 1864 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
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)
Diarrheag
Any 1860 154 (8.3) (7.1, 9.6) 1834 103 (5.6) (4.6, 6.8)
Mild 1860 126 (6.8) (5.7, 8.0) 1834 77 (4.2) (3.3, 5.2)
Moderate 1860 26 (1.4) (0.9, 2.0) 1834 22 (1.2) (0.8, 1.8)
Severe 1860 2 (0.1) (0.0, 0.4) 1834 4 (0.2) (0.1, 0.6)
Grade 4 1860 0 (0.0, 0.2) 1834 0 (0.0, 0.2)
New or worsened muscle paine
Any 1863 540 (29.0) (26.9, 31.1) 1833 99 (5.4) (4.4, 6.5)
Mild 1863 229 (12.3) (10.8, 13.9) 1833 65 (3.5) (2.7, 4.5)
Moderate 1863 291 (15.6) (14.0, 17.3) 1833 33 (1.8) (1.2, 2.5)
Severe 1863 20 (1.1) (0.7, 1.7) 1833 1 (0.1) (0.0, 0.3)
Grade 4 1863 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
New or worsened joint paine
Any 1861 355 (19.1) (17.3, 20.9) 1833 72 (3.9) (3.1, 4.9)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024061
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 1861 184 (9.9) (8.6, 11.3) 1833 44 (2.4) (1.7, 3.2)
Moderate 1861 162 (8.7) (7.5, 10.1) 1833 27 (1.5) (1.0, 2.1)
Severe 1861 9 (0.5) (0.2, 0.9) 1833 1 (0.1) (0.0, 0.3)
Grade 4 1861 0 (0.0, 0.2) 1833 0 (0.0, 0.2)
Any systemic eventh 1868 1214 (65.0) (62.8, 67.2) 1835 518 (28.2) (26.2, 30.3)
Use of antipyretic or pain medicationi 1860 688 (37.0) (34.8, 39.2) 1833 170 (9.3) (8.0, 10.7)
Any dose Fever
Any 2015 238 (11.8) (10.4, 13.3) 1994 12 (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)
Fatiguee
Any 2015 1148 (57.0) (54.8, 59.1) 1994 587 (29.4) (27.4, 31.5)
Mild 2015 485 (24.1) (22.2, 26.0) 1994 342 (17.2) (15.5, 18.9)
Moderate 2015 599 (29.7) (27.7, 31.8) 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)
Headachee
Any 2015 931 (46.2) (44.0, 48.4) 1995 494 (24.8) (22.9, 26.7)
Mild 2015 589 (29.2) (27.3, 31.3) 1995 347 (17.4) (15.8, 19.1)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024062
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 327 (16.2) (14.6, 17.9) 1995 139 (7.0) (5.9, 8.2)
Severe 2015 15 (0.7) (0.4, 1.2) 1995 8 (0.4) (0.2, 0.8)
Grade 4 2015 0 (0.0, 0.2) 1995 0 (0.0, 0.2)
Chillse
Any 2015 505 (25.1) (23.2, 27.0) 1994 110 (5.5) (4.6, 6.6)
Mild 2015 281 (13.9) (12.5, 15.5) 1994 80 (4.0) (3.2, 5.0)
Moderate 2015 203 (10.1) (8.8, 11.5) 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)
Vomitingf
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)
Diarrheag
Any 2015 268 (13.3) (11.8, 14.9) 1995 201 (10.1) (8.8, 11.5)
Mild 2015 211 (10.5) (9.2, 11.9) 1995 157 (7.9) (6.7, 9.1)
Moderate 2015 51 (2.5) (1.9, 3.3) 1995 39 (2.0) (1.4, 2.7)
Severe 2015 6 (0.3) (0.1, 0.6) 1995 5 (0.3) (0.1, 0.6)
Grade 4 2015 0 (0.0, 0.2) 1995 0 (0.0, 0.2)
New or worsened muscle paine
Any 2015 657 (32.6) (30.6, 34.7) 1994 221 (11.1) (9.7, 12.5)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024063
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 2015 296 (14.7) (13.2, 16.3) 1994 138 (6.9) (5.8, 8.1)
Moderate 2015 340 (16.9) (15.3, 18.6) 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 paine
Any 2015 435 (21.6) (19.8, 23.5) 1994 170 (8.5) (7.3, 9.8)
Mild 2015 228 (11.3) (10.0, 12.8) 1994 98 (4.9) (4.0, 6.0)
Moderate 2015 195 (9.7) (8.4, 11.1) 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 eventh 2015 1436 (71.3) (69.2, 73.2) 1995 922 (46.2) (44.0, 48.4)
Use of antipyretic or pain medicationi 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. Only subjects with "Pyrexia, Body temperature increased" dictionary terms and non- missing AE toxicity grade recorded in AE and missing e -diary
related fever measurements, are counted in this row.
e. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or
hospitalization for severe fatigue, severe headache, severe chills, severe muscle pain, or severe joint pain.
f. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or
hospitalization for severe vomiting.
g. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room
visit or hospitalization for severe diarrhea.
h. Any systemic event: any fever, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024064
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)
worsened joint pain.
i. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:24)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 sBL A CBER EDIARY/adce s020 se p3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024065
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 Fevera
nb 2 4
Mean (SD) 1.5 (0.71) 1.8 (0.96)
Median 1.5 1.5
Min, max (1, 2) (1, 3)
Fatigue
nb 22 15
Mean (SD) 2.5 (2.11) 3.0 (2.07)
Median 1.5 3.0
Min, max (1, 9) (1, 7)
Headache
nb 11 18
Mean (SD) 3.0 (2.65) 2.9 (2.50)
Median 1.0 2.0
Min, max (1, 7) (1, 7)
Unknownc 0 1
Chills
nb 6 5
Mean (SD) 2.6 (2.61) 1.8 (0.50)
Median 1.0 2.0
Min, max (1, 7) (1, 2)
Unknownc 1 1
Vomiting
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024066
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
nb 1 3
Mean (SD) 1.0 (NE) 2.0 (1.00)
Median 1.0 2.0
Min, max (1, 1) (1, 3)
Diarrhea
nb 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
nb 10 10
Mean (SD) 1.6 (0.97) 2.0 (1.94)
Median 1.0 1.0
Min, max (1, 4) (1, 7)
New or worsened joint pain
nb 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
nb 7 8
Mean (SD) 2.4 (2.15) 2.3 (1.91)
Median 1.0 1.0
Min, max (1, 6) (1, 6)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024067
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
2 Fevera
nb 13 5
Mean (SD) 2.0 (1.22) 1.8 (1.30)
Median 2.0 1.0
Min, max (1, 5) (1, 4)
Fatigue
nb 26 13
Mean (SD) 3.2 (2.54) 2.8 (1.91)
Median 2.0 2.0
Min, max (1, 10) (1, 6)
Unknownc 0 1
Headache
nb 19 12
Mean (SD) 2.2 (1.40) 2.3 (1.56)
Median 2.0 2.0
Min, max (1, 5) (1, 5)
Unknownc 0 1
Chills
nb 16 4
Mean (SD) 1.7 (1.08) 1.3 (0.50)
Median 1.0 1.0
Min, max (1, 5) (1, 2)
Vomiting
nb 2 2
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024068
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
Mean (SD) 2.0 (1.41) 5.5 (2.12)
Median 2.0 5.5
Min, max (1, 3) (4, 7)
Diarrhea
nb 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
nb 12 5
Mean (SD) 2.7 (1.56) 2.2 (1.64)
Median 2.5 2.0
Min, max (1, 6) (1, 5)
New or worsened joint pain
nb 11 5
Mean (SD) 1.5 (0.93) 1.2 (0.45)
Median 1.0 1.0
Min, max (1, 4) (1, 2)
Use of antipyretic or pain medication
nb 16 7
Mean (SD) 2.0 (2.00) 1.6 (1.51)
Median 1.0 1.0
Min, max (1, 6) (1, 5)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024069
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
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.
c. Includes those events where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:06) Source Data: adcevd Table Generation: 29APR2021 (23:22)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2 unblinded/C4591001 sBLA CBER EDIARY/adce s040 se dur hiv p3 saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024070
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 Fevera
nb 120 25
Mean (SD) 1.2 (0.87) 1.7 (1.52)
Median 1.0 1.0
Min, max (1, 7) (1, 7)
Unknownc 0 1
Fatigue
nb 1433 960
Mean (SD) 2.5 (2.51) 2.9 (2.93)
Median 1.0 2.0
Min, max (1, 23) (1, 23)
Unknownc 6 5
Headache
nb 1264 976
Mean (SD) 2.4 (2.45) 2.6 (2.62)
Median 1.0 1.0
Min, max (1, 25) (1, 22)
Unknownc 5 4
Chills
nb 481 200
Mean (SD) 1.6 (1.35) 2.1 (2.77)
Median 1.0 1.0
Min, max (1, 9) (1, 31)
Unknownc 1 2
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024071
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
Vomiting
nb 34 36
Mean (SD) 1.5 (1.13) 1.4 (0.91)
Median 1.0 1.0
Min, max (1, 5) (1, 4)
Diarrhea
nb 309 324
Mean (SD) 2.0 (2.97) 1.8 (1.91)
Median 1.0 1.0
Min, max (1, 39) (1, 23)
Unknownc 1 0
New or worsened muscle pain
nb 667 329
Mean (SD) 1.7 (1.77) 2.0 (2.56)
Median 1.0 1.0
Min, max (1, 20) (1, 31)
Unknownc 1 1
New or worsened joint pain
nb 342 168
Mean (SD) 1.6 (1.77) 2.2 (2.38)
Median 1.0 1.0
Min, max (1, 24) (1, 17)
Unknownc 3 0
Use of antipyretic or pain medication
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024072
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
nb 805 398
Mean (SD) 1.9 (1.76) 2.2 (2.44)
Median 1.0 1.0
Min, max (1, 16) (1, 23)
Unknownc 1 4
2 Fevera
nb 456 13
Mean (SD) 1.2 (1.03) 2.4 (2.02)
Median 1.0 1.0
Min, max (1, 19) (1, 6)
Unknownc 0 1
Fatigue
nb 1659 617
Mean (SD) 2.2 (2.14) 2.8 (3.04)
Median 1.0 2.0
Min, max (1, 35) (1, 38)
Unknownc 5 10
Headache
nb 1456 657
Mean (SD) 2.2 (2.19) 2.5 (3.01)
Median 1.0 1.0
Min, max (1, 42) (1, 35)
Unknownc 5 10
Chills
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024073
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
nb 1024 115
Mean (SD) 1.3 (0.82) 2.2 (1.98)
Median 1.0 1.0
Min, max (1, 11) (1, 10)
Unknownc 3 2
Vomiting
nb 58 30
Mean (SD) 2.4 (5.27) 1.5 (1.15)
Median 1.0 1.0
Min, max (1, 37) (1, 6)
Unknownc 1 1
Diarrhea
nb 269 206
Mean (SD) 1.8 (2.31) 2.2 (3.33)
Median 1.0 1.0
Min, max (1, 31) (1, 33)
Unknownc 1 3
New or worsened muscle pain
nb 1069 237
Mean (SD) 1.5 (1.35) 2.3 (2.71)
Median 1.0 1.0
Min, max (1, 23) (1, 27)
Unknownc 3 1
New or worsened joint pain
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024074
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
nb 643 147
Mean (SD) 1.6 (1.77) 2.2 (2.28)
Median 1.0 1.0
Min, max (1, 28) (1, 16)
Unknownc 5 2
Use of antipyretic or pain medication
nb 1213 320
Mean (SD) 1.9 (2.00) 2.1 (2.83)
Median 1.0 1.0
Min, max (1, 34) (1, 38)
Unknownc 6 9
>55 Years 1 Fevera
nb 27 9
Mean (SD) 1.2 (0.48) 1.9 (2.32)
Median 1.0 1.0
Min, max (1, 3) (1, 8)
Fatigue
nb 677 447
Mean (SD) 2.4 (2.74) 2.8 (3.43)
Median 1.0 1.0
Min, max (1, 34) (1, 23)
Unknownc 1 3
Headache
nb 503 365
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024075
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) 2.0 (1.86) 2.3 (2.65)
Median 1.0 1.0
Min, max (1, 17) (1, 20)
Unknownc 0 4
Chills
nb 131 69
Mean (SD) 1.6 (1.35) 2.1 (2.13)
Median 1.0 1.0
Min, max (1, 11) (1, 13)
Unknownc 1 1
Vomiting
nb 10 9
Mean (SD) 1.6 (1.58) 1.5 (1.07)
Median 1.0 1.0
Min, max (1, 6) (1, 4)
Unknownc 0 1
Diarrhea
nb 168 131
Mean (SD) 1.8 (1.58) 2.3 (3.34)
Median 1.0 1.0
Min, max (1, 8) (1, 22)
Unknownc 1 0
New or worsened muscle pain
nb 274 165
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024076
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) 1.5 (1.37) 1.9 (2.46)
Median 1.0 1.0
Min, max (1, 14) (1, 18)
Unknownc 1 0
New or worsened joint pain
nb 175 124
Mean (SD) 1.9 (3.32) 1.9 (2.33)
Median 1.0 1.0
Min, max (1, 36) (1, 17)
Use of antipyretic or pain medication
nb 382 224
Mean (SD) 2.0 (2.49) 2.8 (3.27)
Median 1.0 1.0
Min, max (1, 31) (1, 22)
Unknownc 5 7
2 Fevera
nb 224 4
Mean (SD) 1.1 (0.54) 1.8 (1.50)
Median 1.0 1.0
Min, max (1, 6) (1, 4)
Fatigue
nb 952 307
Mean (SD) 2.1 (1.88) 2.8 (4.97)
Median 1.0 1.0
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024077
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
Min, max (1, 20) (1, 69)
Unknownc 3 9
Headache
nb 742 259
Mean (SD) 1.8 (1.43) 2.4 (2.81)
Median 1.0 1.0
Min, max (1, 12) (1, 34)
Unknownc 2 3
Chills
nb 440 57
Mean (SD) 1.2 (0.63) 2.3 (2.72)
Median 1.0 1.0
Min, max (1, 7) (1, 16)
Unknownc 1 2
Vomiting
nb 13 5
Mean (SD) 1.2 (0.60) 1.0 (0.00)
Median 1.0 1.0
Min, max (1, 3) (1, 1)
Diarrhea
nb 154 103
Mean (SD) 1.8 (1.45) 2.1 (2.83)
Median 1.0 1.0
Min, max (1, 9) (1, 26)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024078
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
Unknownc 2 2
New or worsened muscle pain
nb 540 99
Mean (SD) 1.4 (0.97) 1.6 (1.29)
Median 1.0 1.0
Min, max (1, 7) (1, 8)
Unknownc 1 3
New or worsened joint pain
nb 355 72
Mean (SD) 1.6 (2.46) 2.0 (1.71)
Median 1.0 1.0
Min, max (1, 32) (1, 8)
Unknownc 2 1
Use of antipyretic or pain medication
nb 688 170
Mean (SD) 1.8 (1.86) 2.0 (1.96)
Median 1.0 1.0
Min, max (1, 30) (1, 10)
Unknownc 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
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.
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024079
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
b. n = Number of subjects reporting the specified event on any of the 7 days, including subjects with events of unknown duration.
c. Includes those events where the resolution date is partial or missing.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:06) Source Data: adcevd Table Generation: 29APR2021 (23:22)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_s040_se_dur_p 3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024080
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of A ge – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
1 Fevera
nb 2 4
Mean (SD) 2.0 (0.00) 2.5 (2.38)
Median 2.0 1.5
Min, max (2, 2) (1, 6)
Fatigue
nb 22 15
Mean (SD) 1.9 (0.71) 2.8 (1.97)
Median 2.0 2.0
Min, max (1, 4) (1, 7)
Headache
nb 11 18
Mean (SD) 2.0 (1.34) 2.6 (1.98)
Median 1.0 1.5
Min, max (1, 4) (1, 7)
Chills
nb 6 5
Mean (SD) 1.8 (0.75) 2.2 (2.68)
Median 2.0 1.0
Min, max (1, 3) (1, 7)
Vomiting
nb 1 3
Mean (SD) 3.0 (NE) 2.0 (1.00)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024081
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of A ge – 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
nb 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
nb 10 10
Mean (SD) 3.3 (1.95) 2.2 (1.40)
Median 2.5 2.0
Min, max (1, 7) (1, 5)
New or worsened joint pain
nb 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 eventc
nb 33 32
Mean (SD) 2.0 (1.38) 2.6 (1.76)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024082
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of A ge – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
nb 7 8
Mean (SD) 2.1 (0.38) 2.3 (1.49)
Median 2.0 2.0
Min, max (2, 3) (1, 5)
2 Fevera
nb 13 5
Mean (SD) 2.2 (1.59) 3.8 (2.39)
Median 2.0 4.0
Min, max (1, 7) (1, 7)
Fatigue
nb 26 13
Mean (SD) 2.2 (1.39) 2.2 (1.36)
Median 2.0 2.0
Min, max (1, 7) (1, 6)
Headache
nb 19 12
Mean (SD) 2.5 (1.61) 3.9 (2.31)
Median 2.0 4.0
Min, max (1, 7) (1, 7)
Chills
nb 16 4
Mean (SD) 2.6 (1.63) 4.3 (2.63)
Median 2.0 4.0
Min, max (1, 7) (2, 7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024083
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of A ge – Safety Population
Vaccine Group (as Administered)
Dose Systemic Event BNT162b2 (30 μg) Placebo
Vomiting
nb 2 2
Mean (SD) 1.0 (0.00) 2.0 (1.41)
Median 1.0 2.0
Min, max (1, 1) (1, 3)
Diarrhea
nb 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
nb 12 5
Mean (SD) 1.8 (0.62) 3.8 (2.49)
Median 2.0 2.0
Min, max (1, 3) (2, 7)
New or worsened joint pain
nb 11 5
Mean (SD) 3.0 (2.14) 4.6 (2.07)
Median 2.0 5.0
Min, max (1, 7) (2, 7)
Any systemic eventc
nb 39 24
Mean (SD) 2.4 (1.60) 2.1 (1.36)
Median 2.0 2.0
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024084
Onset Days for Systemic Events (Reactogenicity Subset) –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of A ge – 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
nb 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.
c. Any systemic event: any fever, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or
worsened joint pain.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:22)
(Cutoff Date: 13MAR2021, Snapshot Date: 25M AR2021) Output File:
./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_s060_se_onset_hiv_p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024085
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 Fevera
nb 120 25
Mean (SD) 2.5 (1.24) 3.7 (2.10)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Fatigue
nb 1433 960
Mean (SD) 2.0 (1.23) 2.3 (1.62)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nb 1264 976
Mean (SD) 2.4 (1.52) 2.6 (1.71)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Chills
nb 481 200
Mean (SD) 2.2 (1.23) 2.9 (1.78)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Vomiting
nb 34 36
Mean (SD) 3.8 (1.85) 3.6 (2.03)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024086
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
nb 309 324
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
nb 667 329
Mean (SD) 2.3 (1.21) 3.1 (1.78)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
New or worsened joint pain
nb 342 168
Mean (SD) 2.6 (1.42) 3.4 (1.61)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Any systemic eventc
nb 1983 1560
Mean (SD) 2.0 (1.21) 2.3 (1.59)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024087
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
nb 805 398
Mean (SD) 2.4 (1.33) 3.4 (1.85)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
2 Fevera
nb 456 13
Mean (SD) 2.0 (0.55) 3.5 (2.11)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Fatigue
nb 1659 617
Mean (SD) 1.9 (0.76) 2.4 (1.61)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nb 1456 657
Mean (SD) 2.1 (1.01) 2.8 (1.75)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Chills
nb 1024 115
Mean (SD) 1.9 (0.54) 2.7 (1.64)
Median 2.0 2.0
Min, max (1, 6) (1, 7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024088
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
nb 58 30
Mean (SD) 2.6 (1.38) 3.8 (2.12)
Median 2.0 4.0
Min, max (1, 7) (1, 7)
Diarrhea
nb 269 206
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
nb 1069 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
nb 643 147
Mean (SD) 2.1 (0.80) 3.3 (1.82)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
Any systemic eventc
nb 2057 1032
Mean (SD) 1.8 (0.85) 2.4 (1.62)
Median 2.0 2.0
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024089
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
nb 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 Fevera
nb 27 9
Mean (SD) 2.4 (1.21) 3.9 (1.69)
Median 2.0 4.0
Min, max (1, 6) (2, 7)
Fatigue
nb 677 447
Mean (SD) 2.2 (1.27) 2.6 (1.69)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nb 503 365
Mean (SD) 2.5 (1.51) 2.8 (1.75)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Chills
nb 131 69
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024090
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
nb 10 9
Mean (SD) 3.1 (1.91) 3.7 (1.73)
Median 2.5 4.0
Min, max (1, 7) (1, 7)
Diarrhea
nb 168 131
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
nb 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
nb 175 124
Mean (SD) 2.9 (1.62) 3.7 (1.78)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024091
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 eventc
nb 985 751
Mean (SD) 2.2 (1.36) 2.6 (1.64)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Use of antipyretic or pain medication
nb 382 224
Mean (SD) 2.6 (1.48) 3.2 (1.90)
Median 2.0 3.0
Min, max (1, 7) (1, 7)
2 Fevera
nb 224 4
Mean (SD) 2.0 (0.35) 4.3 (2.50)
Median 2.0 4.5
Min, max (1, 6) (1, 7)
Fatigue
nb 952 307
Mean (SD) 2.0 (0.95) 2.8 (1.78)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Headache
nb 742 259
Mean (SD) 2.2 (1.12) 2.9 (1.87)
Median 2.0 2.0
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024092
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
nb 440 57
Mean (SD) 2.0 (0.60) 3.0 (1.88)
Median 2.0 2.0
Min, max (1, 7) (1, 7)
Vomiting
nb 13 5
Mean (SD) 3.2 (2.05) 4.2 (1.79)
Median 2.0 4.0
Min, max (1, 7) (2, 7)
Diarrhea
nb 154 103
Mean (SD) 3.4 (1.72) 3.5 (1.53)
Median 3.0 3.0
Min, max (1, 7) (1, 7)
New or worsened muscle pain
nb 540 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
nb 355 72
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024093
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 eventc
nb 1214 518
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
nb 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.
c. Any systemic event: any fever, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or
worsened joint pain.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 29APR2021 (23:22)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_s06 0_se_onset_p3_saf
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024094
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
16-55 C4591001 1007
10071111 1 03AUG2020 Pain at the
injection site Mod Sev Mild N N N 05AUG2020 3
C4591001 1008
10081782 2 30DEC2020 Redness (cu) 21 21 02JAN2021 2
Redness (svt) N N Sev Sev N N
C4591001 1013
10131180 1 13AUG2020 Pain at the
injection site Mod Sev Mild Mild N Mild 19AUG2020 7
2 03SEP2020 Redness (cu) 21 03SEP2020 1
Redness (svt) Sev N
C4591001 1015
10151015 2 04SEP2020 Redness (cu) 18 21 21 14 13 10SEP2020 5
Redness (svt) N N Mod Sev Sev Mod Mod
Swelling (cu) 11 21 07SEP2020 2
Swelling (svt) N N Mod Sev N N N
C4591001 1015
10151030 1 15AUG2020 Pain at the
injection site Mild Sev Mild Mild N N N 18AUG2020 4
2 04SEP2020 Pain at the
injection site Mod Sev Mild N Mild
C4591001 1016
10161087 1 10AUG2020 Swelling (cu) >21 21AUG2020 12
Swelling (svt) Sev* Sev* Sev Sev* Sev* Sev* Sev*
Pain at the
injection site Mod Mod Sev Mod N N 13AUG2020 4
C4591001 1016
10161106 1 12AUG2020 Pain at the
injection site Mild Sev Mild Mild Mild N 16AUG2020 5
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024095
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1056
10561108 1 01SEP2020 Swelling (cu) 11 20 21 05SEP2020 4
Swelling (svt) Mod Mod Sev Mild*
C4591001 1057
10571368 1 23NOV2020 Pain at the
injection site Mild Sev N N N N N 24NOV2020 2
C4591001 1077
10771013 2 31AUG2020 Redness (cu) >21 03SEP2020 1
Redness (svt) N N N Sev N N
Swelling (cu) 20 20 >21 18 05SEP2020 5
Swelling (svt) N Mod Mod Sev Mod N
C4591001 1083
10831020 2 24AUG2020 Pain at the
injection site Mild Sev N N N N 25AUG2020 2
C4591001 1089
10891025 2 20AUG2020 Pain at the
injection site Mild Sev Mod Mild Mild N 24AUG2020 5
C4591001 1089
10891107 2 02SEP2020 Redness (cu) 18 21 04SEP2020 2
Redness (svt) N Mod Sev N N N
Swelling (cu) 18 21 04SEP2020 2
Swelling (svt) N Mod Sev N N N
C4591001 1089
10891131 1 17AUG2020 Swelling (cu) 21 17AUG2020 1
Swelling (svt) Sev N N N N N N
C4591001 1090
10901043 2 24AUG2020 Pain at the
injection site Sev Sev Mild N N Mild 01NOV2020 70
C4591001 1091
10911046 2 25AUG2020 Redness (cu) 16 21 21 28AUG2020 3
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024096
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
Redness (svt) N Mod Sev Sev N N N
C4591001 1109
11091102 2 21AUG2020 Pain at the
injection site Sev Mod N N N N N 22AUG2020 2
C4591001 1109
11091204 1 11AUG2020 Pain at the
injection site Mod Sev Mild N N N N 13AUG2020 3
C4591001 1120
11201130 2 03SEP2020 Pain at the
injection site Sev Mod Mild Mild Mild N 07SEP2020 5
C4591001 1120
11201238 1 21AUG2020 Pain at the
injection site Mild Sev N N N N N 22AUG2020 2
C4591001 1124
11241039 2 03SEP2020 Swelling (cu) 21 1 04SEP2020 1
Swelling (svt) N Sev N N N N N
Pain at the
injection site N Sev Mod N N N N 05SEP2020 2
C4591001 1125
11251243 1 08DEC2020 Pain at the
injection site Mild Sev Sev Mild N N 11DEC2020 4
C4591001 1127
11271014 2 19AUG2020 Pain at the
injection site Sev Mod Mild Mild Mild N 24AUG2020 5
C4591001 1127
11271022 1 30JUL2020 Pain at the
injection site Sev Mod Mild N N 03AUG2020 4
C4591001 1127
11271032 1 31JUL2020 Pain at the
injection site Mod Sev Mild Mild Mild N N 04AUG2020 5
C4591001 1129
11291045 2 25AUG2020 Redness (cu) 7 21 27AUG2020 2
Redness (svt) N Mild Sev N N
C4591001 1135
11351060 2 28AUG2020 Pain at the
injection site Mild Sev Mild N N N N 30AUG2020 3
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024097
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1135
11351105 2 31AUG2020 Pain at the
injection site N Sev Mod Mild Mild N N 04SEP2020 4
C4591001 1140
11401051 1 06AUG2020 Pain at the
injection site Sev Mod N N N N N 07AUG2020 2
C4591001 1140
11401065 1 06AUG2020 Swelling (cu) 21 10 5 09AUG2020 3
Swelling (svt) N Sev Mild Mild N N
Pain at the
injection site Mild Sev Mod Mild Mild N 10AUG2020 5
2 28AUG2020 Pain at the
injection site N Sev Mod Mod Mild Mild 03SEP2020 6
C4591001 1141
11411008 1 31JUL2020 Pain at the
injection site Sev* Sev* Sev* Sev* Sev* Sev* Sev* 21AUG2020 22
C4591001 1142
11421316 1 24NOV2020 Pain at the
injection site Mild Sev N N N N N 25NOV2020 2
C4591001 1147
11471019 2 24AUG2020 Pain at the
injection site Mod Sev Mild Mild N N N 27AUG2020 4
C4591001 1150
11501152 2 23DEC2020 Pain at the
injection site Sev Mod Mild N 25DEC2020 3
C4591001 1152
11521076 2 03SEP2020 Pain at the
injection site Mild Sev Mild Mild Mild N N 07SEP2020 5
C4591001 1162
11621019 1 03AUG2020 Pain at the
injection site N Sev N N N N 04AUG2020 1
C4591001 1163
11631036 2 25AUG2020 Redness (cu) 21 03SEP2020 7
Redness (svt) N Sev
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024098
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
Pain at the
injection site N Sev 03SEP2020 7
C4591001 1194
11941069 1 20OCT2020 Pain at the
injection site Sev Mod Mild N N N N 22OCT2020 3
C4591001 1194
11941091 1 22OCT2020 Pain at the
injection site Mod Sev Mild Mild Mild N 26OCT2020 5
C4591001 1195
11951119 1 19OCT2020 Redness (cu) 20 21 21 20 20 23OCT2020 5
Redness (svt) Mod Sev Sev Mod Mod N N
Swelling (cu) 21 21 21 20 20 23OCT2020 5
Swelling (svt) Sev Sev Sev Mod Mod N N
C4591001 1197
11971019 2 04NOV2020 Pain at the
injection site N Sev Mild Mild N N N 07NOV2020 3
C4591001 1203
12031010 1 19OCT2020 Pain at the
injection site N Sev Mod Mod Mild 25OCT2020 6
C4591001 1203
12031064 2 16NOV2020 Pain at the
injection site Sev Mod Mild Mild N N N 19NOV2020 4
C4591001 1205
12051079 1 11NOV2020 Pain at the
injection site Sev Mod Mild N N N N 13NOV2020 3
2 02DEC2020 Pain at the
injection site Mod Sev Mod Mild Mild Mild Mild 09DEC2020 8
C4591001 1205
12051080 2 02DEC2020 Pain at the
injection site Mild Sev N N N N N 03DEC2020 2
C4591001 1210
12101005 2 12NOV2020 Pain at the
injection site Sev N N N N 13NOV2020 1
C4591001 1210
12101006 2 13NOV2020 Pain at the
injection site N Sev Mild N N N N 15NOV2020 2
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024099
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1210
12101028 1 30OCT2020 Pain at the
injection site Sev Mild N N N N 31OCT2020 2
2 20NOV2020 Pain at the
injection site Sev Mild N N N 21NOV2020 2
C4591001 1210
12101033 1 02NOV2020 Pain at the
injection site Sev Mild Mild Mild Mild N 06NOV2020 5
C4591001 1210
12101050 2 26NOV2020 Pain at the
injection site Sev Mild N N N N N 27NOV2020 2
C4591001 1212
12121007 2 17NOV2020 Pain at the
injection site Mod Sev Mild Mild N N N 20NOV2020 4
C4591001 1212
12121015 2 18NOV2020 Pain at the
injection site Sev Mod Mod N N N N 20NOV2020 3
C4591001 1212
12121016 2 18NOV2020 Pain at the
injection site Sev Mild Mild N N N N 20NOV2020 3
C4591001 1213
12131013 2 17NOV2020 Pain at the
injection site Sev Sev Mod N N 19NOV2020 3
C4591001 1213
12131059 1 09NOV2020 Pain at the
injection site Mod Sev Mild N N N N 11NOV2020 3
C4591001 1214
12141025 1 03NOV2020 Pain at the
injection site Sev Mod N N N N 04NOV2020 2
C4591001 1214
12141043 1 09NOV2020 Pain at the
injection site Sev Mild Mild N N N N 11NOV2020 3
C4591001 1214
12141045 1 09NOV2020 Pain at the
injection site Sev Mild N N N N N 10NOV2020 2
C4591001 1217
12171002 1 22OCT2020 Pain at the
injection site Sev Mod Mild Mild N N 26OCT2020 5
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024100
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1217
12171011 1 23OCT2020 Pain at the
injection site Sev N N N N N 23OCT2020 1
C4591001 1217
12171012 1 23OCT2020 Pain at the
injection site Mild Sev Mild N N N N 25OCT2020 3
C4591001 1217
12171016 2 16NOV2020 Pain at the
injection site Sev Mild N N N N N 17NOV2020 2
C4591001 1226
12261008 2 24AUG2020 Pain at the
injection site Sev N N N N N 25AUG2020 1
C4591001 1226
12261011 1 05AUG2020 Pain at the
injection site Sev Mod N N N N 06AUG2020 2
C4591001 1226
12261044 1 07AUG2020 Pain at the
injection site N N Sev Mild Mild N 12AUG2020 3
C4591001 1226
12261089 2 01SEP2020 Redness (cu) 21 21 12 05SEP2020 3
Redness (svt) N N Sev Sev Mod N N
Swelling (cu) 21 21 04SEP2020 2
Swelling (svt) N N Sev Sev N N N
C4591001 1226
12261096 1 11AUG2020 Pain at the
injection site Mild Sev Mild N N Mild N 16AUG2020 6
C4591001 1226
12261140 1 12AUG2020 Pain at the
injection site N Sev N N N N N 13AUG2020 1
C4591001 1226
12262255† 2 06NOV2020 Pain at the
injection site Sev* Sev Sev* N N N N 08NOV2020 3
C4591001 1229
12291001 2 14OCT2020 Pain at the
injection site Sev Mod N N N N 16OCT2020 2
C4591001 1229
12291002 1 22SEP2020 Pain at the
injection site N Sev N N N N N 23SEP2020 1
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024101
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1229
12291008 2 15OCT2020 Swelling (cu) 12 21 16OCT2020 2
Swelling (svt) Mod Sev N N N N N
C4591001 1229
12291024† 1 28SEP2020 Redness (cu) 21 28SEP2020 1
Redness (svt) Sev N N N N N N
Swelling (cu) 21 29SEP2020 1
Swelling (svt) N Sev N N N N N
C4591001 1229
12291032 1 28SEP2020 Redness (cu) 21 28SEP2020 1
Redness (svt) Sev N N N N N N
C4591001 1229
12291047 1 29SEP2020 Pain at the
injection site Sev Mild N N N N 30SEP2020 2
C4591001 1229
12291082 1 01OCT2020 Redness (cu) 21 01OCT2020 1
Redness (svt) Sev N N N N
C4591001 1229
12291104 1 05OCT2020 Pain at the
injection site Sev Sev Mod Mod Mild 26OCT2020 22
C4591001 1229
12291105 2 26OCT2020 Pain at the
injection site Mod Sev N Mod N N N 29OCT2020 4
C4591001 1229
12291108 1 05OCT2020 Redness (cu) 21 21 08OCT2020 3
Redness (svt) N Sev N Sev N N N
Swelling (cu) 21 08OCT2020 1
Swelling (svt) N N N Sev N N N
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024102
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1229
12291109 1 05OCT2020 Redness (cu) 21 06OCT2020 1
Redness (svt) N Sev N N N N
C4591001 1229
12291114 1 06OCT2020 Redness (cu) 21 06OCT2020 1
Redness (svt) Sev N N N N N
C4591001 1229
12291124 1 06OCT2020 Pain at the
injection site Mod Sev Mild N N 08OCT2020 3
C4591001 1229
12291127 2 27OCT2020 Redness (cu) 21 28OCT2020 1
Redness (svt) Sev
C4591001 1230
12301018 1 24SEP2020 Pain at the
injection site Sev Sev Mild N N N N 26SEP2020 3
C4591001 1230
12301021 1 24SEP2020 Redness (cu) 21 24SEP2020 1
Redness (svt) Sev N N N N N
C4591001 1230
12301072 1 29SEP2020 Redness (cu) 21 29SEP2020 1
Redness (svt) Sev N N N N N N
C4591001 1230
12301133 1 05OCT2020 Redness (cu) 2 21 07OCT2020 1
Redness (svt) N Sev N N N N
C4591001 1231
12311018 2 27AUG2020 Pain at the
injection site N Sev Mild Mild Mild N N 31AUG2020 4
C4591001 1231
12311055 1 11AUG2020 Pain at the
injection site Mild Sev Mod Mild Mild Mild Mild 17AUG2020 7
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024103
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1231
12311162 1 13AUG2020 Pain at the
injection site Mild Sev Mild N N N N 15AUG2020 3
C4591001 1231
12311231 2 03SEP2020 Pain at the
injection site Mod Sev Mod Mod Mod Mild N 08SEP2020 6
C4591001 1231
12311295 2 03SEP2020 Pain at the
injection site N Mild Sev Mod Mild Mild 10SEP2020 7
C4591001 1231
12311304 2 04SEP2020 Pain at the
injection site Sev N Mild N N N 07SEP2020 3
C4591001 1231
12311386 1 15AUG2020 Pain at the
injection site Mod Sev N N N N N 16AUG2020 2
C4591001 1231
12311494 2 06SEP2020 Pain at the
injection site Sev Mod Mild Mild N N 09SEP2020 4
C4591001 1231
12311513 2 08SEP2020 Pain at the
injection site N Sev Mild N N N N 10SEP2020 2
C4591001 1232
12321010 2 02SEP2020 Pain at the
injection site Sev N Mild N N N 05SEP2020 3
C4591001 1246
12461025 1 28SEP2020 Pain at the
injection site Mod Sev Mild N N N N 30SEP2020 3
C4591001 1246
12461055† 1 02OCT2020 Redness (cu) 21 02OCT2020 1
Redness (svt) Sev N N N N N N
C4591001 1247
12471033 2 15OCT2020 Pain at the
injection site N Sev Sev N N 19OCT2020 2
C4591001 1247
12471071 1 28SEP2020 Swelling (cu) 21 29SEP2020 1
Swelling (svt) N Sev N N N N N
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024104
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1247
12471156 2 22OCT2020 Redness (cu) 21 23OCT2020 1
Redness (svt) N Sev N N N N
Swelling (cu) 21 23OCT2020 1
Swelling (svt) N Sev N N N N
C4591001 1247
12471159 1 05OCT2020 Pain at the
injection site Sev Mild N N N N 06OCT2020 2
C4591001 1247
12471199 1 06OCT2020 Redness (cu) 21 21 07OCT2020 2
Redness (svt) Sev Sev N N
Swelling (cu) 21 06OCT2020 1
Swelling (svt) Sev N N N
18-55 C4591001 1001
10011034^ 1 20MAY2020 Pain at the
injection site Sev Mod Mild Mild Mild N N 24MAY2020 5
C4591001 1003
10031061^ 1 22JUN2020 Pain at the
injection site Mild Sev N N N N N 23JUN2020 2
>55 C4591001 1001
10011084 1 28JUL2020 Pain at the
injection site Mod Sev N N N N N 29JUL2020 2
C4591001 1055
10551017 1 10AUG2020 Pain at the
injection site Mild Sev N N N N 11AUG2020 2
C4591001 1085
10851059 2 02SEP2020 Redness (cu) 21 15 15 05SEP2020 3
Redness (svt) N Sev Mod Mod N N N
Swelling (cu) 21 15 05SEP2020 3
Swelling (svt) N Sev N Mod N N N
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024105
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1087
10871040 1 08AUG2020 Swelling (cu) 21 12 20 11AUG2020 3
Swelling (svt) N Sev Mod Mod N N N
C4591001 1090
10901155 2 31AUG2020 Pain at the
injection site Mild Sev N N N N N 01SEP2020 2
C4591001 1090
10901158 2 31AUG2020 Pain at the
injection site Mod Sev Mod Sev Mod Mod Mod 15SEP2020 16
C4591001 1091
10911024 2 24AUG2020 Redness (cu) 3 21 15 >21 28AUG2020 3
Redness (svt) N N Sev Mod Sev N N
C4591001 1109
11091008 2 18AUG2020 Redness (cu) 15 21 22AUG2020 3
Redness (svt) N N Mod N Sev N N
C4591001 1109
11091093 2 24AUG2020 Pain at the
injection site Mod Sev Mod Mild Mild
C4591001 1110
11101015 1 01AUG2020 Redness (cu) 21 02AUG2020 1
Redness (svt) N Sev N N N N N
C4591001 1123
11231012 2 19AUG2020 Pain at the
injection site Sev Mod Mod N N N 22AUG2020 3
C4591001 1124
11241031 2 03SEP2020 Redness (cu) 21 20 15 07SEP2020 3
Redness (svt) N N Sev Mod Mod N N
C4591001 1140
11401034 1 04AUG2020 Pain at the
injection site N Sev N N N N 05AUG2020 1
C4591001 1142
11421044 2 29AUG2020 Swelling (cu) 21 10 01SEP2020 2
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024106
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
Swelling (svt) N Sev Mild N N
C4591001 1142
11421093 2 04SEP2020 Redness (cu) 21 21 16 16 13SEP2020 7
Redness (svt) N N Sev Sev Mod Mod
C4591001 1145
11451012 2 02SEP2020 Pain at the
injection site Mild Sev Mild N N N N 04SEP2020 3
C4591001 1146
11461025 2 03SEP2020 Pain at the
injection site Sev Mod N N N N 04SEP2020 2
C4591001 1194
11941074 2 12NOV2020 Redness (cu) 21 >21 17NOV2020 2
Redness (svt) Sev Sev N
Swelling (cu) 21 >21 17NOV2020 2
Swelling (svt) Sev Sev N
C4591001 1195
11951046 2 05NOV2020 Pain at the
injection site Mild Sev N N N N N 06NOV2020 2
C4591001 1197
11971090 1 19OCT2020 Redness (cu) 21 9 5 23OCT2020 3
Redness (svt) N N Sev Mild Mild N N
C4591001 1197
11971095 2 07NOV2020 Pain at the
injection site Mod Mod Sev Mild Mild N N 11NOV2020 5
C4591001 1205
12051018 2 16NOV2020 Redness (cu) 21 17NOV2020 1
Redness (svt) Sev N N N N
C4591001 1207
12071004 1 23OCT2020 Redness (cu) 11 21 5 26OCT2020 3
Redness (svt) N Mod Sev Mild N N N
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024107
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1224
12241016 2 02SEP2020 Redness (cu) 19 17 21 21 20 20 08SEP2020 6
Redness (svt) N Mod Mod Sev Sev Mod Mod
C4591001 1224
12241019 2 02SEP2020 Redness (cu) 6 21 21 05SEP2020 3
Redness (svt) N Mild Sev Sev N N N
C4591001 1226
12261033 1 06AUG2020 Pain at the
injection site Mild Sev N N N N N 07AUG2020 2
C4591001 1226
12261149 1 13AUG2020 Redness (cu) 21 10 15AUG2020 2
Redness (svt) Sev Mild N N N N
C4591001 1229
12291040 2 21OCT2020 Swelling (cu) 20 21 23OCT2020 2
Swelling (svt) N Mod Sev N N N N
C4591001 1229
12291056 2 21OCT2020 Swelling (cu) 21 22OCT2020 1
Swelling (svt) N Sev N N N N N
C4591001 1229
12291067 1 30SEP2020 Redness (cu) 10 21 03OCT2020 3
Redness (svt) N Mild N Sev N N
2 21OCT2020 Redness (cu) 21 26OCT2020 1
Redness (svt) Sev N
C4591001 1229
12291084 2 23OCT2020 Pain at the
injection site Sev 25OCT2020 3
C4591001 1229
12291087 1 02OCT2020 Redness (cu) 21 04OCT2020 1
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024108
16.2.7.2.1 Listing of Severe and Grade 4 Local Reactions (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
Redness (svt) N Sev N N N
Swelling (cu) 21 21 04OCT2020 2
Swelling (svt) Sev Sev N N N
C4591001 1229
12291097 1 05OCT2020 Redness (cu) 21 05OCT2020 1
Redness (svt) Sev N N N N N N
C4591001 1246
12461056 2 23OCT2020 Redness (cu) 21 4 24OCT2020 1
Redness (svt) N Sev N N N N N
C4591001 1247
12471056 2 15OCT2020 Pain at the
injection site Mod Sev Mod Mild Mild N N 19OCT2020 5
Abbreviations: cu = caliper units; Dur = duration; Mod = moderate; N = none; Sev = severe; svt = severity.
Note: † = Human immunodeficiency virus (HIV) -positive subject, ^ = Phase 1 subjects, * = Local reactions recorded by the investigator on the AE log
page.
a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1.
b. The maximum measurable size fo r redness and swelling in the electronic diary (e -diary) was 21 caliper units. Redness and swelling exceeding 21
caliper units are reported as >21. Study sites recorded injection site redness or swelling in centimeters. These were convert ed to caliper unit s (1 caliper
unit = 0.5 centimeters).
c. Stop date is the date the reaction was last reported.
d. Duration (days) was calculated as the difference from the start of the first reported reaction to resolution of the last reported reaction, inclusive. If the
reaction continued beyond Day 7, the calculation includes all days from the last e -diary day until the date of resolution collected on the case report form. If
the reaction was ongoing at the time of the subsequent vaccination, the end date/day for the reaction is the date/day that the next vaccine was administered,
which was used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 30APR2021 (10:23)
(Cutoff Date: 13MAR2021, Snap shot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_l004_sevlr_all
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024109
16.2.7.2.2 Listing of Severe and Grade 4 Local Reactions – Subjects Enrolled in Multiple Sites
Rel Daya
Age Group (Years) Subject Dose No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur (Days)d
No subject meets the reporting criteria.
Abbreviation: Dur = duration.
a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1.
b. The maximum measurable size for redness and swelling in the electronic diary (e -diary) was 21 caliper units. Redness and swelling exceeding 21
caliper units are reported as >21. Study sites recorded injection site redness or swelling in centimeters. These were convert ed to caliper units (1 caliper
unit = 0.5 centimeters).
c. Stop date is the date the reaction was last reported.
d. Du ration (days) was calculated as the difference from the start of the first reported reaction to resolution of the last report ed reaction, inclusive. If the
reaction continued beyond Day 7, the calculation includes all days from the last e -diary day until t he date of resolution collected on the case report form. If
the reaction was ongoing at the time of the subsequent vaccination, the end date/day for the reaction is the date/day that th e next vaccine was administered,
which was used for the duration calcul ation.
PFIZER CONFIDENTIAL SDTM Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 30APR2021 (10:23)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_l004_sevlr_me nrol_all
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024110
16.2.7.2.3 Listing of Severe and Grade 4 Local Reactions – Subjects With Indeterminate Vaccine –
All Subjec ts ≥16 Years of Age
Rel Daya
Age Group (Years) Subject Dose No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur (Days)d
No subject meets the reporting criteria.
Abbreviation: Dur = duration.
a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1.
b. The maximum measurable size for redness and swelling in the electronic diary (e -diary) was 21 caliper units. Redness and swelling exceeding 21
caliper units are reporte d as >21. Study sites recorded injection site redness or swelling in centimeters. These were converted to caliper units (1 caliper
unit = 0.5 centimeters).
c. Stop date is the date the reaction was last reported.
d. Duration (days) was calculated as the difference from the start of the first reported reaction to resolution of the last reported reaction, inclusive. If the
reaction continued beyond Day 7, the calculation includes all days from the last e -diary day until the date of resolution collecte d on the case report form. If
the reaction was ongoing at the time of the subsequent vaccination, the end date/day for the reaction is the date/day that th e next vaccine was administered,
which was used for the duration calculation.
PFIZER CONFIDENTIAL SDT M Creation: 29APR2021 (22:11) Source Data: adfacevd Table Generation: 30APR2021 (03:41)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_sBLA_CBER_EDIARY/adce_l004_sevlr_iv _all
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024111
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
16-55 C4591001 1001
10011125 1 04AUG2020 Fatigue Mod Mod Sev Mild N 07AUG2020 4
Headache Mod Mod Sev Mod N 07AUG2020 4
New or worsened
muscle pain N N Sev Sev* N 07AUG2020 2
New or worsened
joint pain N Mild Sev N N 06AUG2020 2
C4591001 1003
10031160 2 27AUG2020 Headache N Sev N N N N N 28AUG2020 1
C4591001 1003
10031191 2 02SEP2020 Headache Mild Sev Mild N N Mild N 07SEP2020 6
C4591001 1005
10051024 2 31AUG2020 Fatigue Sev N N N N 01SEP2020 1
C4591001 1005
10051066 2 02SEP2020 Fatigue N Sev N N N N 03SEP2020 1
Chills N Sev N N N N 03SEP2020 1
C4591001 1005
10051434 2 12JAN2021 Chills N Sev N N N 13JAN2021 1
C4591001 1005
10051442 1 22DEC2020 Fatigue N Sev Mild Mild N Mild N 27DEC2020 5
C4591001 1006
10061024 2 31AUG2020 Fatigue N Sev Mod N N N N 02SEP2020 2
C4591001 1006
10061037 2 04SEP2020 Fatigue N Sev N Mod Mod N 09SEP2020 5
C4591001 1006
10061040 1 14AUG2020 Headache Mild Mild Sev N N N Mod 21AUG2020 8
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024112
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1006
10061053 2 09SEP2020 Fatigue Mod Sev Mild Mild Mild Mild Mild 16SEP2020 8
Chills Mod Sev Mild N N N N 11SEP2020 3
C4591001 1006
10061084 2 10SEP2020 Fatigue Sev N N Mild 17SEP2020 8
C4591001 1006
10061185 2 21DEC2020 Chills N Sev N N N N N 22DEC2020 1
C4591001 1006
10061192 2 22DEC2020 Headache N Sev N Mild N N N 25DEC2020 3
C4591001 1006
10061210 2 23DEC2020 Headache N Sev N N N N N 24DEC2020 1
C4591001 1006
10061246 1 10DEC2020 Fatigue N N Sev N N N N 12DEC2020 1
C4591001 1007
10071097 2 20AUG2020 New or worsened
muscle pain N Sev Mod Mod Mod Mod Mod 01SEP2020 12
C4591001 1007
10071111 1 03AUG2020 Chills N Sev N N N N 04AUG2020 1
New or worsened
muscle pain N Sev N N N N 04AUG2020 1
C4591001 1007
10071130 2 26AUG2020 Chills N Sev N N N N N 27AUG2020 1
New or worsened
muscle pain N Sev N N N N N 27AUG2020 1
C4591001 1007
10071146 2 27AUG2020 New or worsened
muscle pain N Sev N N N N 28AUG2020 1
C4591001 1007
10071157 2 31AUG2020 Fatigue N Sev N N N N N 01SEP2020 1
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024113
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
Chills N Sev N N N N N 01SEP2020 1
C4591001 1007
10071487 1 01DEC2020 Headache N Sev Mild N N 03DEC2020 2
C4591001 1007
10071503 1 03DEC2020 New or worsened
muscle pain Sev Mod N N 04DEC2020 2
C4591001 1009
10091028 2 31AUG2020 New or worsened
muscle pain N Sev N N N N N 01SEP2020 1
C4591001 1011
10111035 2 03SEP2020 Fatigue Sev Sev Sev Mild Mild N N 07SEP2020 5
Headache N Sev Mod N Mild N N 07SEP2020 4
Chills N Sev Mod N N N N 05SEP2020 2
New or worsened
muscle pain N Sev N N N N N 04SEP2020 1
C4591001 1011
10111129 2 21SEP2020 Headache Sev N N N N N 21SEP2020 1
C4591001 1012
10121001 1 03AUG2020 Headache Mild Sev N N N N 04AUG2020 2
C4591001 1013
10131005 1 28JUL2020 Headache N N N N Sev N 01AUG2020 1
C4591001 1013
10131013 2 18AUG2020 Headache N Sev Mild Mild Mod Mild N 23AUG2020 5
C4591001 1013
10131030 2 18AUG2020 Chills N Sev N N N N N 19AUG2020 1
C4591001 1013
10131055 2 24AUG2020 New or worsened
muscle pain N Sev N N N 26AUG2020 1
C4591001 1013
10131059 2 25AUG2020 Fatigue N Sev Mild N N N N 27AUG2020 2
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024114
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1013
10131062 2 24AUG2020 Fatigue N Sev N N N N N 25AUG2020 1
C4591001 1013
10131084 2 26AUG2020 Vomiting N N N N N Mod Sev 01SEP2020 2
C4591001 1013
10131180 2 03SEP2020 New or worsened
muscle pain N Sev 06SEP2020 2
New or worsened
joint pain N Sev 06SEP2020 2
C4591001 1015
10151030 1 15AUG2020 Fatigue N Sev Mod Mild Mild Sev Mod 21AUG2020 6
2 04SEP2020 Fatigue N Sev Mod Mod N 08SEP2020 4
Headache N Sev Mod Mod N 08SEP2020 4
New or worsened
muscle pain N Sev Mod N N 07SEP2020 3
C4591001 1015
10151035 2 04SEP2020 Fatigue Sev N N N N N 05SEP2020 1
New or worsened
muscle pain Sev N N N N N 05SEP2020 1
New or worsened
joint pain Sev N N N N N 05SEP2020 1
C4591001 1016
10161004 2 19AUG2020 Oral temperature
(°C) 36.4 39.6 37.1 36.8 36.4 36.2 35.7 20AUG2020 1
C4591001 1016
10161078 2 28AUG2020 Headache N Sev N N N N N 29AUG2020 1
Chills N Sev N N N N N 29AUG2020 1
New or worsened
muscle pain N Sev N N N N N 29AUG2020 1
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024115
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1016
10161349 2 25NOV2020 Headache Mod Sev Mild N N N N 27NOV2020 3
C4591001 1018
10181013 1 30JUL2020 Fatigue N N N N N Sev N 04AUG2020 1
C4591001 1018
10181055 2 25AUG2020 Fatigue N Sev Mod N Mild Mild Mild 31AUG2020 6
New or worsened
muscle pain N Sev Mild N Mild Mild N 30AUG2020 5
C4591001 1018
10181089 2 27AUG2020 Headache Mild Sev* N N N N N 28AUG2020 2
New or worsened
joint pain N Sev N N N N N 28AUG2020 1
C4591001 1018
10181151 2 03SEP2020 Fatigue Sev Mild N N N N 04SEP2020 2
C4591001 1042
10421070 2 31AUG2020 Fatigue Mod Sev Mod N N N N 02SEP2020 3
C4591001 1042
10421105 2 02SEP2020 Oral temperature
(°C) 36.7 38.9 36.7 36.7 36.8 36.6 36.1 03SEP2020 1
C4591001 1044
10441244 2 14DEC2020 Fatigue N Sev Mild Mild Mild Mild N 19DEC2020 5
New or worsened
muscle pain N Sev Mild N N N N 16DEC2020 2
C4591001 1044
10441245 2 14DEC2020 Fatigue Sev Mild N N N 16DEC2020 2
C4591001 1044
10441287 1 11DEC2020 Fatigue Mod Sev Mild Mild N Mild Mild
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024116
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1052
10521017 1 21AUG2020 Diarrhea N Mild Mod Mod Mod Sev Mod 27AUG2020 6
C4591001 1052
10521036 1 26AUG2020 Fatigue Mod Sev N N N N 27AUG2020 2
C4591001 1055
10551003 2 27AUG2020 Fatigue N Sev Mild N N N N 29AUG2020 2
C4591001 1057
10571028 2 08SEP2020 Fatigue N Sev N N N N N 09SEP2020 1
C4591001 1057
10571362† 1 30OCT2020 Oral temperature
(°C) 38.9 38.5 38.3 37.8 37.9 37.4 01NOV2020 3
Fatigue Mod Mod Sev Mild Mod Sev 05NOV2020 7
Headache Mod Mod Sev Mild Mod Mod 05NOV2020 7
Vomiting N N Mod Sev Mod N 03NOV2020 3
C4591001 1066
10661027 1 13AUG2020 Fatigue Mild N Mod* Sev Mod Mod 20AUG2020 8
C4591001 1071
10711019 2 02SEP2020 Fatigue N Sev N N N 03SEP2020 1
C4591001 1071
10711039 2 04SEP2020 Headache N N Mod Sev Mild Mild 21SEP2020 16
C4591001 1071
10711065 2 09SEP2020 Headache Sev Sev N N N N Mild 17SEP2020 9
C4591001 1073
10731021 1 31JUL2020 Fatigue Mild Sev Mod N N N 02AUG2020 3
2 24AUG2020 Fatigue N Sev Mod N N N N 26AUG2020 2
C4591001 1073
10731064 2 01SEP2020 Fatigue Mod Mod Mod Sev N N N 04SEP2020 4
Headache N Mod N Sev N N N 04SEP2020 3
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024117
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1073
10731083 2 02SEP2020 Fatigue Mod Sev N N N N 03SEP2020 2
Chills N Sev N N N N 03SEP2020 1
C4591001 1077
10771013 2 31AUG2020 Fatigue N Sev N Mod Mod N 05SEP2020 5
Chills N Sev N N N N 01SEP2020 1
C4591001 1079
10791039 2 25AUG2020 Headache N Mild N N Mod Sev 02SEP2020 8
C4591001 1079
10791040 2 24AUG2020 Headache Sev N 28AUG2020 1
C4591001 1079
10791097 2 31AUG2020 Chills Sev N N N N 01SEP2020 1
C4591001 1079
10791112 1 12AUG2020 Headache Mild Sev N N N N N 13AUG2020 2
C4591001 1079
10791115 1 12AUG2020 Headache Mild Mild Mild Sev Mod Mild 18AUG2020 7
C4591001 1079
10791127 2 03SEP2020 Oral temperature
(°C) 36.8 39 37.2 36.9 36.8 36.6 36.6 04SEP2020 1
C4591001 1080
10801009 2 03SEP2020 Headache Sev Mod N N 05SEP2020 2
C4591001 1081
10811033 2 03SEP2020 Fatigue N Sev N N N N 04SEP2020 1
C4591001 1082
10821036 1 04AUG2020 Headache Mod N Mild N N N Sev 11AUG2020 8
2 25AUG2020 Headache N Sev Sev N N N Mod 31AUG2020 6
C4591001 1083
10831020 2 24AUG2020 Fatigue N Sev N N N N 25AUG2020 1
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024118
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1083
10831060 1 06AUG2020 Oral temperature
(°C) 36.5 37.8 37.8 38.6 38.6 38.9 38.7 13AUG2020 5
C4591001 1084
10841068 2 28AUG2020 Chills N Sev N 29AUG2020 1
C4591001 1084
10841091 2 28AUG2020 Fatigue N Sev N N N N N 29AUG2020 1
C4591001 1084
10841102 2 31AUG2020 Headache N Sev Mod Mod Mild N N 04SEP2020 4
C4591001 1084
10841118 1 10AUG2020 Fatigue N Sev N N N N N 11AUG2020 1
C4591001 1084
10841146 2 02SEP2020 Fatigue N Sev Mild N N N N 04SEP2020 2
C4591001 1084
10841187 1 14AUG2020 Fatigue Mild Sev Mild N N N 16AUG2020 3
C4591001 1084
10841188 1 14AUG2020 Headache N N Mod Sev N N N 17AUG2020 2
2 04SEP2020 Headache N N N N N N Sev 10SEP2020 1
C4591001 1085
10851018 1 01AUG2020 Diarrhea N N N Mod N Mod Sev 07AUG2020 4
C4591001 1085
10851075 2 29AUG2020 Fatigue Sev Mod Mild N N N N 31AUG2020 3
C4591001 1087
10871045 1 10AUG2020 Fatigue Sev Sev Sev Sev Sev Sev Sev 24AUG2020 15
New or worsened
muscle pain N N N N Mod Mod Sev 24AUG2020 11
2 31AUG2020 Fatigue Mild Mod Sev Sev Sev Sev
Headache Mild Mod Mod Mod Mod Sev
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024119
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1088
10881010 1 12AUG2020 Chills N Mild Sev N N N N 14AUG2020 2
Diarrhea N Mild Sev Sev Mild Mild N 17AUG2020 5
C4591001 1088
10881012 2 04SEP2020 Fatigue N Sev N N N N N 05SEP2020 1
C4591001 1089
10891025 2 20AUG2020 Headache N Sev Mod Mod Mild Mild 26AUG2020 6
C4591001 1089
10891054 1 04AUG2020 Fatigue N Mild Mod Sev Sev 14AUG2020 10
C4591001 1089
10891078 2 27AUG2020 Fatigue Sev N N N N N 28AUG2020 1
Diarrhea N Sev N N N N 29AUG2020 1
C4591001 1089
10891082 1 07AUG2020 Headache N Sev N N 08AUG2020 1
C4591001 1089
10891103 2 31AUG2020 New or worsened
joint pain N N Sev N N 02SEP2020 1
C4591001 1090
10901015 2 24AUG2020 Fatigue N Sev N N N N 25AUG2020 1
C4591001 1090
10901022 2 28AUG2020 Headache Sev Mod N N N N 30AUG2020 2
C4591001 1090
10901043 2 24AUG2020 Headache Mild Sev N N N Mild 30AUG2020 7
Chills N Sev N N N N 25AUG2020 1
C4591001 1090
10901045 2 24AUG2020 Headache N Sev N Mild N N 27AUG2020 3
Chills N Sev Mild N N N 26AUG2020 2
090177e196f19a09\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0024120
16.2.7.3.1 Listing of Severe and Grade 4 Systemic Events (Reactogenicity Subset) –
All Subjects ≥16 Years of Age – Safety Population
Rel Daya
Age Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1090
10901050 2 24AUG2020 Fatigue N Sev N N N N 25AUG2020 1
Headache N Sev N N N N 25AUG2020 1
Chills N Sev N N N N 25AUG2020 1
New or worsened
muscle pain N Sev N N N N 25AUG2020 1
C4591001 1090
10901095 1 07AUG2020 Oral temperature
(°C) 36.7 37.6 39.3 36.7 36.7 37.2 36.7 09AUG2020 1
2 28AUG2020 Oral temperature
(°C) 37 39.7 38 37.3 37.1 36.4 37 30AUG2020 2
C4591001 1090
10901104 1 07AUG2020 Fatigue N Mild Sev Mod Mild N N 11AUG2020 4
New or worsened
muscle pain N Mod Sev Mod N N N 10AUG2020 3
C4591001 1091
10911037 1 04AUG2020 Fatigue N Sev N N N N N 05AUG2020 1
C4591001 1091
10911051 2 26AUG20
…[truncated]