Document text
4
• Gently invert the vial containing the COMIRNATY
10 times to mix.
• Do not shake.
• Inspect the vaccine in the vial.
• The vaccine will be an off -white suspension. Do not
use if vaccine is discolored or contains particulate matter.
• Record the date and time of dilution on the COMIRNATY vial label.
• Store between 2°C to 25°C (35°F to 77°F).
• Discard any unused vaccine 6 hours after dilution.
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
• Using aseptic technique, cleanse the vial stopper
with a single -use antiseptic swab, and withdraw
0.3 mL of COMIRNATY preferentially using low
dead -volume syringes and/or needles.
• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
• Administer immediately.
FDA-CBER-2021-5683-0651484
8 16 through 55 years of age included in the safety population who were monitored for reactogenicity with an
electronic diary.
Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions,
respectively, within 7 days of each dose of COMIRNATY and placebo for participants 56 years of age and
older.
In participants 16 to 55 years of age after receiving Dose 2, the mean duration of pain at the injection site was
2.5 days (range 1 to 70 days), for redness 2.2 days (range 1 to 9 days), and for swelling 2.1 days (range 1 to
8 days) for participants in the COMIRNATY group. In participants 56 years of age and older after receiving
Dose 2, the mean duration of pain at the injection site was 2.4 days (range 1 to 36 days), for redness 3.0 days
(range 1 to 34 days), and for swelling 2.6 days (range 1 to 34 days) for participants in the COMIRNATY group.
Table 1: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 16 Through 55 Years of
Age – Reactogenicity Subset of the Safety Population*
COMIRNATY
Dose 1
Na=2899
nb (%) Placebo
Dose 1
Na=2908
nb (%) COMIRNATY
Dose 2
Na=2682
nb (%) Placebo
Dose 2
Na=2684
nb (%)
Rednessc
Any (>2.0 cm) 156 (5.4) 28 (1.0) 151 (5.6) 18 (0.7)
Mild 113 (3.9) 19 (0.7) 90 (3.4) 12 (0.4)
Moderate 36 (1.2) 6 (0.2) 50 (1.9) 6 (0.2)
Severe 7 (0.2) 3 (0.1) 11 (0.4) 0
Swellingc
Any (>2.0 cm) 184 (6.3) 16 (0.6) 183 (6.8) 5 (0.2)
Mild 124 (4.3) 6 (0.2) 110 (4.1) 3 (0.1)
Moderate 54 (1.9) 8 (0.3) 66 (2.5) 2 (0.1)
Severe 6 (0.2) 2 (0.1) 7 (0.3) 0
Pain at the injection sited
Any 2426 (83.7) 414 (14.2) 2101 (78.3) 312 (11.6)
Mild 1464 (50.5) 391 (13.4) 1274 (47.5) 284 (10.6)
Moderate 923 (31.8) 20 (0.7) 788 (29.4) 28 (1.0)
Severe 39 (1.3) 3 (0.1) 39 (1.5) 0
Note s: Reactions were collected in the electronic diary (e -diary) from Day 1 to Day 7 after vaccination
No Grade 4 solicited local reactions were reported in participants 16 through 55 years of age
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
a N = N umber of participants reporting at least 1 yes or no response for the specified reaction after the specified dose The N for
each reaction was the same, therefore, this information was included in the column header
b n = N umber of participants with the specified reaction
c Mild: >2 0 to ≤5 0 cm; M oderate: >5 0 to ≤ 10 0 cm; S evere: >10 0 cm
d Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity
FDA-CBER-2021-5683-0651488
9 Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 16 Through 55 Years of
Age – Reactogenicity Subset of the Safety Population*
COMIRNATY
Dose 1
Na=2899
nb (%) Placebo
Dose 1
Na=2908
nb (%) COMIRNATY
Dose 2
Na=2682
nb (%) Placebo
Dose 2
Na=2684
nb (%)
Fever
≥38.0℃ 119 (4.1) 25 (0.9) 440 (16.4) 11 (0.4)
≥38.0℃ to 38.4℃ 86 (3.0) 16 (0.6) 254 (9.5) 5 (0.2)
>38.4℃ to 38.9℃ 25 (0.9) 5 (0.2) 146 (5.4) 4 (0.1)
>38.9℃ to 40.0℃ 8 (0.3) 4 (0.1) 39 (1.5) 2 (0.1)
>40.0℃ 0 0 1 (0.0) 0
Fatiguec
Any 1431 (49.4) 960 (33.0) 1649 (61.5) 614 (22.9)
Mild 760 (26.2) 570 (19.6) 558 (20.8) 317 (11.8)
Moderate 630 (21.7) 372 (12.8) 949 (35.4) 283 (10.5)
Severe 41 (1.4) 18 (0.6) 142 (5.3) 14 (0.5)
Headachec
Any 1262 (43.5) 975 (33.5) 1448 (54.0) 652 (24.3)
Mild 785 (27.1) 633 (21.8) 699 (26.1) 404 (15.1)
Moderate 444 (15.3) 318 (10.9) 658 (24.5) 230 (8.6)
Severe 33 (1.1) 24 (0.8) 91 (3.4) 18 (0.7)
Chillsc
Any 479 (16.5) 199 (6.8) 1015 (37.8) 114 (4.2)
Mild 338 (11.7) 148 (5.1) 477 (17.8) 89 (3.3)
Moderate 126 (4.3) 49 (1.7) 469 (17.5) 23 (0.9)
Severe 15 (0.5) 2 (0.1) 69 (2.6) 2 (0.1)
Vomitingd
Any 34 (1.2) 36 (1.2) 58 (2.2) 30 (1.1)
Mild 29 (1.0) 30 (1.0) 42 (1.6) 20 (0.7)
Moderate 5 (0.2) 5 (0.2) 12 (0.4) 10 (0.4)
Severe 0 1 (0.0) 4 (0.1) 0
Diarrheae
Any 309 (10.7) 323 (11.1) 269 (10.0) 205 (7.6)
Mild 251 (8.7) 264 (9.1) 219 (8.2) 169 (6.3)
Moderate 55 (1.9) 58 (2.0) 44 (1.6) 35 (1.3)
Severe 3 (0.1) 1 (0.0) 6 (0.2) 1 (0.0)
New or worsened muscle painc
Any 664 (22.9) 329 (11.3) 1055 (39.3) 237 (8.8)
Mild 353 (12.2) 231 (7.9) 441 (16.4) 150 (5.6)
Moderate 296 (10.2) 96 (3.3) 552 (20.6) 84 (3.1)
Severe 15 (0.5) 2 (0.1) 62 (2.3) 3 (0.1)
New or worsened joint painc
Any 342 (11.8) 168 (5.8) 638 (23.8) 147 (5.5)
Mild 200 (6.9) 112 (3.9) 291 (10.9) 82 (3.1)
Moderate 137 (4.7) 55 (1.9) 320 (11.9) 61 (2.3)
Severe 5 (0.2) 1 (0.0) 27 (1.0) 4 (0.1)
FDA-CBER-2021-5683-0651489
10 COMIRNATY
Dose 1
Na=2899
nb (%) Placebo
Dose 1
Na=2908
nb (%) COMIRNATY
Dose 2
Na=2682
nb (%) Placebo
Dose 2
Na=2684
nb (%)
Use of antipyretic or
pain medicationf 805 (27.8) 398 (13.7) 1213 (45.2) 320 (11.9)
Note s: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e -diary) from Day 1 to Day 7 after
each dose
No Grade 4 solicited systemic reactions were reported in participants 16 through 55 years of age
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
a N = N umber of participants reporting at least 1 yes or no response for the specified reaction after the specified dose The N for
each reaction or use of antipyretic or pain medication was the same, therefore, this information was included in the column
header
b n = Number of participants with the specified reaction
c Mild: does not interfere with activity; M oderate: some interference with activity; S evere: prevents daily activity
d Mild: 1 to 2 times in 24 hours; M oderate: >2 times in 24 hours; S evere: requires intravenous hydration
e Mild: 2 to 3 loose stools in 24 hours; M oderate: 4 to 5 loose stools in 24 hours; S evere: 6 or more loose stools in 24 hours
f Severity was not collected for use of antipyretic or pain medication
Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Reactogenicity Subset of the Safety Population*
COMIRNATY
Dose 1
Na=2008
nb (%) Placebo
Dose 1
Na=1989
nb (%) COMIRNATY
Dose 2
Na=1860
nb (%) Placebo
Dose 2
Na=1833
nb (%)
Rednessc
Any (>2.0 cm) 106 (5.3) 20 (1.0) 133 (7.2) 14 (0.8)
Mild 71 (3.5) 13 (0.7) 65 (3.5) 10 (0.5)
Moderate 30 (1.5) 5 (0.3) 58 (3.1) 3 (0.2)
Severe 5 (0.2) 2 (0.1) 10 (0.5) 1 (0.1)
Swellingc
Any (>2 .0 cm) 141 (7.0) 23 (1.2) 145 (7.8) 13 (0.7)
Mild 87 (4.3) 11 (0.6) 80 (4.3) 5 (0.3)
Moderate 52 (2.6) 12 (0.6) 61 (3.3) 7 (0.4)
Severe 2 (0.1) 0 4 (0.2) 1 (0.1)
Pain at the injection sited
Any (>2 .0 cm) 1408 (70.1) 185 (9.3) 1230 (66.1) 143 (7.8)
Mild 1108 (55.2) 177 (8.9) 873 (46.9) 138 (7.5)
Moderate 296 (14.7) 8 (0.4) 347 (18.7) 5 (0.3)
Severe 4 (0.2) 0 10 (0.5) 0
Note s: Reactions were collected in the electronic diary (e -diary) from Day 1 to Day 7 after vaccination
No Grade 4 solicited local reactions were reported in participants 56 years of age and older
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
a N = N umber of participants reporting at least 1 yes or no response for the specified reaction aft er the specified dose The N for
each reaction was the same, therefore, the information was included in the column header
b n = Number of participants with the specified reaction
c Mild: >2 0 to ≤5 0 cm; M oderate: >5 0 to ≤ 10 0 cm; S evere: >10 0 cm
d Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity
Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Reactogenicity Subset of the Safety Population*
FDA-CBER-2021-5683-0651490
11 COMIRNATY
Dose 1
Na=2008
nb (%) Placebo
Dose 1
Na=1989
nb (%) COMIRNATY
Dose 2
Na=1860
nb (%) Placebo
Dose 2
Na=1833
nb (%)
Fever
≥38.0℃ 26 (1.3) 8 (0.4) 219 (11.8) 4 (0.2)
≥38.0℃ to 38.4℃ 23 (1.1) 3 (0.2) 158 (8.5) 2 (0.1)
>38.4℃ to 38.9℃ 2 (0.1) 3 (0.2) 54 (2.9) 1 (0.1)
>38.9℃ to 40.0℃ 1 (0.0) 2 (0.1) 7 (0.4) 1 (0.1)
>40.0℃ 0 0 0 0
Fatiguec
Any 677 (33.7) 447 (22.5) 949 (51.0) 306 (16.7)
Mild 415 (20.7) 281 (14.1) 391 (21.0) 183 (10.0)
Moderate 259 (12.9) 163 (8.2) 497 (26.7) 121 (6.6)
Severe 3 (0.1) 3 (0.2) 60 (3.2) 2 (0.1)
Grade 4 0 0 1 (0.1) 0
Headachec
Any 503 (25.0) 363 (18.3) 733 (39.4) 259 (14.1)
Mild 381 (19.0) 267 (13.4) 464 (24.9) 189 (10.3)
Moderate 120 (6.0) 93 (4.7) 256 (13.8) 65 (3.5)
Severe 2 (0.1) 3 (0.2) 13 (0.7) 5 (0.3)
Chillsc
Any 130 (6.5) 69 (3.5) 435 (23.4) 57 (3.1)
Mild 102 (5.1) 49 (2.5) 229 (12.3) 45 (2.5)
Moderate 28 (1.4) 19 (1.0) 185 (9.9) 12 (0.7)
Severe 0 1 (0.1) 21 (1.1) 0
Vomitingd
Any 10 (0.5) 9 (0.5) 13 (0.7) 5 (0.3)
Mild 9 (0.4) 9 (0.5) 10 (0.5) 5 (0.3)
Moderate 1 (0.0) 0 1 (0.1) 0
Severe 0 0 2 (0.1) 0
Diarrheae
Any 168 (8.4) 130 (6.5) 152 (8.2) 102 (5.6)
Mild 137 (6.8) 109 (5.5) 125 (6.7) 76 (4.1)
Moderate 27 (1.3) 20 (1.0) 25 (1.3) 22 (1.2)
Severe 4 (0.2) 1 (0.1) 2 (0.1) 4 (0.2)
New or worsened muscle painc
Any 274 (13.6) 165 (8.3) 537 (28.9) 99 (5.4)
Mild 183 (9.1) 111 (5.6) 229 (12.3) 65 (3.5)
Moderate 90 (4.5) 51 (2.6) 288 (15.5) 33 (1.8)
Severe 1 (0.0) 3 (0.2) 20 (1.1) 1 (0.1)
New or worsened joint painc
Any 175 (8.7) 124 (6.2) 353 (19.0) 72 (3.9)
Mild 119 (5.9) 78 (3.9) 183 (9.8) 44 (2.4)
Moderate 53 (2.6) 45 (2.3) 161 (8.7) 27 (1.5)
Severe 3 (0.1) 1 (0.1) 9 (0.5) 1 (0.1)
Use of antipyretic or
pain medicationf 382 (19.0) 224 (11.3) 688 (37.0) 170 (9.3)
FDA-CBER-2021-5683-0651491
12 COMIRNATY
Dose 1
Na=2008
nb (%) Placebo
Dose 1
Na=1989
nb (%) COMIRNATY
Dose 2
Na=1860
nb (%) Placebo
Dose 2
Na=1833
nb (%)
Note s: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e -diary) from Day 1 to Day 7 after
each dose
The only Grade 4 solicited systemic reaction reported in participants 56 years of age and older was fatigue
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
a N = N umber of participants reporting at least 1 yes or no response for the specified reaction after the specified dose N for each
reaction or use of antipyretic or pain medication was the same, therefore was included in the column header
b n = Number of part icipants with the specified reaction
c Mild: does not interfere with activity; M oderate: some interference with activity; S evere: prevents daily activity ; Grade 4
reactions were defined in the clinical study protocol as emergency room visit or hospitali zation for severe fatigue, severe
headache, severe chills, severe muscle pain, or severe joint pain
d Mild: 1 to 2 times in 24 hours; M oderate: >2 times in 24 hours; S evere: requires intravenous hydration; Grade 4 emergency visit
or hospitalization for severe vomiting
e Mild: 2 to 3 loose stools in 24 hours; M oderate: 4 to 5 loose stools in 24 hours; S evere: 6 or more loose stools in 24 hours ;
Grade 4: emergency room or hospitalization for severe diarrhea
f Severity was not collected for use of anti pyretic or pain medication
Table 5 and Table 6 present the frequency and severity of reported solicited local and systemic reactions,
respectively, within 7 days of each dose of COMIRNATY and placebo for participants 16 years of age and
older with confirmed stable HIV infection .
Table 5: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – HIV -Positive Participants 16 Years of
Age and Older – Reactogenicity Subset of the Safety Population*
COMIRNATY
Dose 1
Na=54
nb (%) Placebo
Dose 1
Na=56
nb (%) COMIRNATY
Dose 2
Na=60
nb (%) Placebo
Dose 2
Na=62
nb (%)
Rednessc
Any (>2.0 cm) 2 (3.7) 3 (5.4) 4 (6.7) 1 (1.6)
Mild 2 (3.7) 1 (1.8) 3 (5.0) 1 (1.6)
Moderate 0 0 1 (1.7) 0
Severe 0 2 (3.6) 0 0
Swellingc
Any (>2.0 cm) 3 (5.6) 1 (1.8) 5 (8.3) 0
Mild 2 (3.7) 0 2 (3.3) 0
Moderate 1 (1.9) 0 3 (5.0) 0
Severe 0 1 (1.8) 0 0
FDA-CBER-2021-5683-0651492
13 COMIRNATY
Dose 1
Na=54
nb (%) Placebo
Dose 1
Na=56
nb (%) COMIRNATY
Dose 2
Na=60
nb (%) Placebo
Dose 2
Na=62
nb (%)
Pain at the injection sited
Any 34 (63.0) 9 (16.1) 32 (53.3) 5 (8.1)
Mild 26 (48.1) 8 (14.3) 22 (36.7) 5 (8.1)
Moderate 8 (14.8) 1 (1.8) 9 (15.0) 0
Severe 0 0 1 (1.7) 0
Note s: Reactions were collected in the electronic diary (e -diary) from Day 1 to Day 7 after vaccination
No Grade 4 solicited local reactions were reported in HIV-p ositive participants 16 years of age and older
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
a N = N umber of participants reporting at least 1 yes or no response for the specified reaction after the specified dose The N for
each reaction was the same, therefore, this information was included in the column header
b n = N umber of participants with the specified reaction
c Mild: >2 0 to ≤5 0 cm; M oderate: >5 0 to ≤ 10 0 cm; S evere: >10 0 cm
d Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity
Table 6: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – HIV -Positive Participants 16 Years of
Age and Older – Reactogenicity Subset of the Safety Population*
COMIRNATY
Dose 1
Na=54
nb (%) Placebo
Dose 1
Na=56
nb (%) COMIRNATY
Dose 2
Na=60
nb (%) Placebo
Dose 2
Na=62
nb (%)
Fever
≥38.0℃ 1 (1.9) 4 (7.1) 9 (15.0) 5 (8.1)
≥38.0℃ to 38.4℃ 1 (1.9) 2 (3.6) 4 (6.7) 5 (8.1)
>38.4℃ to 38.9℃ 0 0 4 (6.7) 0
>38.9℃ to 40.0℃ 0 2 (3.6) 1 (1.7) 0
>40.0℃ 0 0 0 0
Fatiguec
Any 22 (40.7) 15 (26.8) 24 (40.0) 12 (19.4)
Mild 15 (27.8) 9 (16.1) 12 (20.0) 5 (8.1)
Moderate 7 (13.0) 5 (8.9) 9 (15.0) 7 (11.3)
Severe 0 1 (1.8) 3 (5.0) 0
Headachec
Any 11 (20.4) 18 (32.1) 18 (30.0) 12 (19.4)
Mild 7 (13.0) 10 (17.9) 8 (13.3) 8 (12.9)
Moderate 4 (7.4) 7 (12.5) 8 (13.3) 4 (6.5)
Severe 0 1 (1.8) 2 (3.3) 0
Chillsc
Any 6 (11.1) 5 (8.9) 14 (23.3) 4 (6.5)
Mild 5 (9.3) 4 (7.1) 5 (8.3) 3 (4.8)
Moderate 1 (1.9) 1 (1.8) 8 (13.3) 1 (1.6)
Severe 0 0 1 (1.7) 0
FDA-CBER-2021-5683-0651493
14 COMIRNATY
Dose 1
Na=54
nb (%) Placebo
Dose 1
Na=56
nb (%) COMIRNATY
Dose 2
Na=60
nb (%) Placebo
Dose 2
Na=62
nb (%)
Vomitingd
Any 1 (1.9) 3 (5.4) 2 (3.3) 2 (3.2)
Mild 1 (1.9) 1 (1.8) 1 (1.7) 1 (1.6)
Moderate 0 0 1 (1.7) 1 (1.6)
Severe 0 2 (3.6) 0 0
Diarrheae
Any 5 (9.3) 8 (14.3) 4 (6.7) 9 (14.5)
Mild 5 (9.3) 6 (10.7) 1 (1.7) 6 (9.7)
Moderate 0 1 (1.8) 2 (3.3) 3 (4.8)
Severe 0 1 (1.8) 1 (1.7) 0
New or worsened muscle painc
Any 9 (16.7) 10 (17.9) 10 (16.7) 5 (8.1)
Mild 7 (13.0) 7 (12.5) 5 (8.3) 1 (1.6)
Moderate 2 (3.7) 3 (5.4) 5 (8.3) 4 (6.5)
Severe 0 0 0 0
New or worsened joint painc
Any 5 (9.3) 7 (12.5) 10 (16.7) 5 (8.1)
Mild 5 (9.3) 4 (7.1) 4 (6.7) 1 (1.6)
Moderate 0 3 (5.4) 6 (10.0) 4 (6.5)
Severe 0 0 0 0
Use of antipyretic or
pain medicationf 7 (13.0) 8 (14.3) 16 (26.7) 7 (11.3)
Note s: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e -diary) from Day 1 to Day 7 after
each dose
No Grade 4 solicited systemic reactions were reported in HIV -positive participants 16 years of age and older
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
a N = N umber of participants reporting at least 1 yes or no response for the specified reaction after the specified dose The N for
each event or use of antipyretic or pain medication was the same, therefore, this information was included in the column header
b n = Number of participants with the specified reaction
c Mild: does not interfere with activity; M oderate: some interference with activity; Severe: prevents daily activity
d Mild: 1 to 2 times in 24 hours; M oderate: >2 times in 24 hours; S evere: requires intravenous hydration
e Mild: 2 to 3 loose stools in 24 hours; M oderate: 4 to 5 loose stools in 24 hours; S evere: 6 or more loose stools in 24 hours
f Severity was not collected for use of antipyretic or pain medication
Unsolicited Adverse Events
Upon issuance of the EUA for COMIRNATY, participants were unblinded to offer placebo participants
COMIRNATY. A dverse events are reported as incidence rates per 100 person -years to account for the variable
exposure since unblinding began in a phased manner for participants in the study. Adverse events detailed
below for participants 16 years of age and older are for the placebo-controlled blinded follow-up period up to
the participants’ unblinding dates.
Serious Adverse Events
In Study 2, among participants 16 through 55 years of age who had r eceived at least 1 dose of vaccine or
placebo ( COMIRNATY =12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant
unblinding date in ongoing follow-up were reported at an incidence rate of 2.1 per 100 person-years among
FDA-CBER-2021-5683-0651494
15 COMIRNAT Y recipients and 2.4 per 100 person-years among placebo recipients. In a similar analysis, in
participants 56 years of age and older ( COMIRNATY =8931, placebo = 8895), serious adverse events were
reported at an incidence rate of 4.9 per 100 person- years am ong COMIRNATY recipients and 4.6 per
100 person-years among placebo recipients who received at least 1 dose of COMIRNATY or placebo,
respectively. In these analyses, 58.2% of study participants had at least 4 months of follow-up after Dose 2.
Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the
participant unblinding date in ongoing follow-up were reported at an incidence rate of 6.6 per 100 person- years
among COMIRNATY recipients and 6.9 per 100 person-years among placebo recipients.
There were no notable patterns between treatment groups for specific categories of serious adverse events
(including neurologic, neuro-inflammatory, and thrombotic events) that would sugge st a causal relationship to
COMIRNATY.
Non- Serious Adverse Events
Overall in Study 2 in which 12,995 participants 16 through 55 years of age received COMIRNATY and
13,026 participants received placebo , all events, which include non-serious adverse events from Dose 1 up to
the participant unblinding date in ongoing follow- up were reported at an incidence rate of 88.4 per
100 person-years among participants who received COMIRNATY and 43.5 per 100 person-years among
participants in the placebo group, for par ticipants who received at least 1 dose. In a similar analysis, in
participants 56 years of age and older ( COMIRNATY = 8931, placebo = 8895), all events, which include
non-serious adverse events were reported at an incidence rate of 75.7 per 100 person- years among participants
who received COMIRNATY and 43.3 per 100 person-years among participants in the placebo group, for
participants who received at least 1 dose. Among participants with confirmed stable HIV infection, all events,
which include non-serious adverse events from Dose 1 up to the participant unblinding date in ongoing
follow-up were reported at an incidence rate of 95.8 per 100 person-years among participants who received
COMIRNATY and 52.0 per 100 person-years among participants in the placebo group, for participants who
received at least 1 dose.
In these analyses, 58.2% of study participants had at least 4 months of follow-up after Dose 2. The higher
frequency of reported unsolicited non- serious adverse events among COMIRNATY recipients (inclu sive of
stable HIV infection) compared to placebo recipients was primarily attributed to local and systemic adverse
events reported during the first 7 days following each dose of vaccine that are consistent with adverse reactions
solicited among participan ts in the reactogenicity subset and presented in Table 3 and Table 4.
Throughout the placebo-controlled safety follow-up period to date, Bell’s palsy (facial paralysis) was reported
by 4 participants in the COMIRNATY group and 2 participants in the placebo group. Onset of facial paralysis
was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. In the placebo
group the onset of facial paralysis was Day 32 and Day 102. Currently available information is insufficient to
determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances
between treatment groups for specific categories of non -serious adverse events (including other neurologic or
neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY.
6.2 Post Marketing Experience
The following adverse reactions have been identified during post marketing use of COMIRNATY, including
under Emergency Use Authorization. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to rel iably estimate their frequency or establish a causal relationship to
vaccine exposure.
FDA-CBER-2021-5683-0651495
18 hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants
with known stable infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV). In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of COMIRNATY or placebo. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Particip ants are planned to be followed for up to 24 months, for assessments of
safety and efficacy against COVID -19.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the COMIRNATY group and 18,379 in the placebo group) who did not have evidence of
prior infection with SARS-CoV-2 through 7 days after the second dose. Table 7 presents the specific demographic characteristics in the studied population. Table 7: Demographics ( Population F or the P rimary E fficacy E ndpoint)
a
COMIRNATY
(N=18,242)
n (%) Placebo
(N=18,379)
n (%)
Sex
Male 9318 (51.1) 9225 (50.2)
Female 8924 (48.9) 9154 (49.8)
Age (years)
Mean (SD) 50.6 (15.70) 50.4 (15.81)
Median 52.0 52.0
Min, max (12, 89) (12, 91)
Age group
≥12 through 15 years 46 (0.3) 42 (0.2)
≥16 through 64 years 14,216 (77.9) 14,299 (77.8)
≥65 through 74 years 3176 (17.4) 3226 (17.6)
≥75 years 804 (4.4) 812 (4.4)
Race
White 15,110 (82.8) 15,301 (83.3)
Black or African American 1617 (8.9) 1617 (8.8)
American Indian or Alaska Native 118 (0.6) 106 (0.6)
Asian 815 (4.5) 810 (4.4)
Native Hawaiian or other Pacific Islander 48 (0.3) 29 (0.2)
Otherb 534 (2.9) 516 (2.8)
Ethnicity
Hispanic or Latino 4886 (26.8) 4857 (26.4)
Not Hispanic or Latino 13,253 (72.7) 13,412 (73.0)
Not reported 103 (0.6) 110 (0.6)
Comorbiditiesc
Yes 8432 (46.2) 8450 (46.0)
No 9810 (53.8) 9929 (54.0)
a All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no other
important protocol deviations as determined by the clinician, and have no evidence of SARS -CoV -2 infection prior to 7 days
after Dose 2
b Includes multiracial and not reported
c Number of participants who have 1 or more comorbidities that increase the risk of severe COVID -19 disease :
FDA-CBER-2021-5683-0651498
19 • Chronic lung disease (e g , emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or
moderate to severe asthma
• Significant cardiac disease (e g , heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and
pulmonary hypertension)
• Obesity (body mass index ≥30 kg/m2)
• Diabetes (Type 1, Type 2, or gestational)
• Liver disease
• Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation)
Efficacy Against COVID-19
The population in the primary efficacy analysis included all participants 12 years of age and older who had been
enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020,
16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began
enrollment from October 15, 2020.
The vaccine efficacy information is presented in Table 8. Table 8: Vaccine Efficacy – First COVID- 19 Occur rence From 7 Days After Dose 2, by Age
Subgroup – Participants Without Evidence of Infection and Participants With or Without
Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
First COVID -19 occurrence from 7 days after Dose 2 in participants without evidence of prior
SARS -CoV -2 infection *
Subgroup COMIRNATY
Na=18,198
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=18,325
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)
All participantse 8
2.214 (17,411) 162
2.222 (17,511) 95.0
(90.3, 97.6)f
16 to 64 years 7
1.706 (13,549) 143
1.710 (13,618) 95.1
(89.6, 98.1)g
65 years and older 1
0.508 (3848) 19
0.511 (3880) 94.7
(66.7, 99.9)g
65 to 74 years 1
0.406 (3074) 14
0.406 (3095) 92.9
(53.1, 99.8)g
75 years and older 0
0.102 (774) 5
0.106 (785) 100.0
(-13.1, 100.0)g
First COVID -19 occurrence from 7 days after Dose 2 in participants with or without * evidence of prior
SARS -CoV -2 infection
Subgroup COMIRNATY
Na=19,965
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=20,172
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)
All participantse 9
2.332 (18,559) 169
2.345 (18,708) 94.6
(89.9, 97.3)f
16 to 64 years 8
1.802 (14,501) 150
1.814 (14,627) 94.6
(89.1, 97.7)g
65 years and older 1 19 94.7
FDA-CBER-2021-5683-0651499
20 0.530 (4044) 0.532 (4067) (66.8, 99.9)g
65 to 74 years 1
0.424 (3239) 14
0.423 (3255) 92.9
(53.2, 99.8)g
75 years and older 0
0.106 (805) 5
0.109 (812) 100.0
(-12.1, 100.0)g
Note: Confirmed cases were determined by Reverse Transcription -Polymerase Chain Reaction (RT -PCR) and at least 1 symptom
consistent with COVID -19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased mu scle pain; new loss of taste or smell; sore throat; diarrhea; vomiting)
* Participants who had no evidence of past SARS -CoV-2 infection (i e , N -binding antibody [serum] negative at Visit 1 and
SARS -CoV -2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled
visit prior to 7 days after Dose 2 were included in the analysis
a N = Number of participants in the specified group
b n1 = Number of participants meeting the endpoint definition
c Total surv eillance time in 1000 person -years for the given endpoint across all participants within each group at risk for the
endpoint Time period for COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period
d n2 = Number of partici pants at risk for the endpoint
e No confirmed cases were identified in participants 12 to 15 years of age
f Two-sided credible interval for vaccine efficacy was calculated using a beta- binomial model with a beta (0 700102, 1) prior for
θ=r(1 -VE)/(1+r(1 -VE)), where r is the ratio of surveillance time in the active vaccine group over that in the placebo group
g Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time
Updated efficacy analyses were performed with additional confirmed COVID -19 cases accrued during blinded
placebo -controlled follow-up through March 13, 2021, representing up to 6 months of follow-up after Dose 2
for participants in the efficacy population. The updated vaccine efficacy information is presented in Table 9. Table 9: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup – Participants Without Evidence of Infection and Participants With or Without
Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population During the Placebo -Controlled Follow -up Period
First COVID -19 occurrence from 7 days after Dose 2 in participants without evidence of prior
SARS -CoV-2 infection *
Subgroup COMIRNATY
Na=20,998
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=21,096 Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CIe)
All participant sf 77
6.247 (20,712 ) 850
6.003 (20,713 ) 91.3
(89.0, 93.2)
16 through 64 years 70
4.859 (15,519) 710
4.654 (15,515 ) 90.6
(87.9, 92.7)
65 years and older 7
1.233 (4192 ) 124
1.202 (4226 ) 94.5
(88.3, 97.8)
65 through 74 years 6
0.994 (3350) 98
0.966 (3379) 94.1
(86.6, 97.9)
75 years and older 1
0.239 (842) 26
0.237 (847) 96.2
(76.9, 99.9)
FDA-CBER-2021-5683-0651500
21 First COVID -19 occurrence from 7 days after Dose 2 in participants with or without * evidence of prior
SARS -CoV -2 infection
Subgroup COMIRNATY
Na=22,166
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=22,320
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% C Ie)
All participant sf 81
6.509 (21,642 ) 873
6.274 (21,689 ) 91.1
(88.8, 93.0)
16 through 64 years 74
5.073 (16,218 ) 727
4.879 (16,269 ) 90.2
(87.6, 92.4)
65 years and older 7
1.267 (4315 ) 128
1.232 (4326) 94.7
(88.7, 97.9)
65 through 74 years 6
1.021 (3450) 102
0.992 (3468) 94.3
(87.1, 98.0)
75 years and older 1
0.246 (865) 26
0.240 (858) 96.2
(77.2, 99.9)
Note: Confirmed cases were determined by Reverse Transcription -Polymerase Chain Reaction (RT -PCR) and at least 1 symptom
consistent with COVID -19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting)
* Participants who had no evidence of past SARS -CoV-2 infection (i e, N-binding antibody [serum] negative at Visit 1 and
SARS -CoV -2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis
a N = N umber of p articipants in the specified group
b n1 = Number of participants meeting the endpoint definition
c Total surveillance time in 1000 person -years for the given endpoint across all p articipants within each group at risk for the endpoint
Time period for COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period
d n2 = Number of participants at risk for the endpoint
e Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time
f Included confirmed cases in participants 12 t hrough 15 years of age: 0 in the COMIRNATY group (both without and with or without
evidence of prior SARS -CoV-2 infection); 16 and 18 in the placebo group ( without and with or without evidence of prior SARS -
CoV -2 infection, respectively)
The updated subgroup analyses of vaccine efficacy by demographic characteristics a re presented in Table 10
and Table 11 .
Table 10: Vaccine Efficacy – First COVID- 19 Occurrence From 7 Days After Dose 2 – Participants
Without Evidence of Infection * Prior to 7 Days After Dose 2 by Demographic Characteristics –
Evaluable Efficacy (7 Days) Population Dur ing the Placebo -Controlled Follow -up Period
Subgroup COMIRNATY
Na=20,998
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=21,096
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
Sex
Male 42
3.246 (10 ,637) 399
3.047 (10 ,433) 90.1
(86.4, 93.0)
Female 35
3.001 (10 ,075) 451
2.956 (10,280) 92.4
(89.2, 94.7)
Ethnicity
FDA-CBER-2021-5683-0651501
22 Subgroup COMIRNATY
Na=20,998
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=21,096
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
Hispanic or Latino 29
1.786 (5161) 241
1.711 (5120) 88.5
(83.0, 92.4)
Not Hispanic or Latino 47
4.429 (15 ,449) 609
4.259 (15,484) 92.6
(90.0, 94.6)
Race
Black or African American 4
0.545 (1737) 48
0.527 (1737) 91.9
(78.0, 97.9)
White 67
5.208 (17,186) 747
5.026 (17,256) 91.3
(88.9, 93.4)
All othersf 6
0.494 (1789) 55
0.451 (1720) 90.0
(76.9, 96.5)
Country
Argentina 15
1.012 (2600) 108
0.986 (2586) 86.5
(76.7, 92.7)
Brazil 12
0.406 (1311) 80
0.374 (1293) 86.2
(74.5, 93.1)
Germany 0
0.047 (236) 1
0.048 (242) 100.0
(-3874.2, 100.0)
South Africa 0
0.080 (291) 9
0.074 (276) 100.0
(53.5, 100.0)
Turkey 0
0.027 (228) 5
0.025 (222) 100.0
(-0.1, 100.0)
United States 50
4.674 (16,046) 647
4.497 (16,094) 92.6
(90.1, 94.5)
Notes: Confirmed cases were determined by Reverse Transcription -Polymerase Chain Reaction (RT -PCR) and at least 1 symptom
consistent with COVID -19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting)
Included confirmed cases in participants 1 2 through 15 years of age: 0 in the COMIRNATY group; 16 in the placebo group
* Participants who had no evidence of past SARS -CoV-2 infection (i e, N-binding antibody [serum] negative at Visit 1 and
SARS -CoV -2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis
a N = N umber of participants in the specified group
b n1 = Number of participants meeting the endpoint definition
c Total surveillance time in 1000 person -years for the given endpoint across all participants within each group at risk for the endpoint
Time period for COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period
d n2 = Number of participants at risk for the endpoint
e Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time
f All others = American Indian or Alaska Native, Asia n, Native Hawaiian or other Pacific Islander, multiracial, and not reported race
categories
Table 11: Vaccine Efficacy – First COVID- 19 Occurrence From 7 Days After Dose 2 – Participants With
or Without* Evidence of Infection Prior to 7 Days After Dose 2 by Demographic Characteristics – Evaluable Efficacy (7 Days) Population During the Placebo -Controlled
Follow- up Period
FDA-CBER-2021-5683-0651502
23 Subgroup COMIRNATY
Na=22,166
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=22,320
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
Sex
Male 44
3.376 (11,103) 411
3.181 (10,920) 89.9
(86.2, 92.8)
Female 37
3.133 (10,539) 462
3.093 (10,769) 92.1
(88.9, 94.5)
Ethnicity
Hispanic or Latino 32
1.862 (5408) 245
1.794 (5391) 87.4
(81.8, 91.6)
Not Hispanic or Latino 48
4.615 (16,128) 628
4.445 (16,186) 92.6
(90.1, 94.6)
Race
Black or African American 4
0.611 (1958) 49
0.601 (1985) 92.0
(78.1, 97.9)
White 69
5.379 (17,801) 768
5.191 (17,880) 91.3
(88.9, 93.3)
All othersf 8
0.519 (1883) 56
0.481 (1824) 86.8
(72.1, 94.5)
Country
Argentina 16
1.033 (2655) 110
1.017 (2670) 85.7
(75.7, 92.1)
Brazil 14
0.441 (1419) 82
0.408 (1401) 84.2
(71.9, 91.7)
Germany 0
0.047 (237) 1
0.048 (243) 100.0
(-3868.6, 100.0)
South Africa 0
0.099 (358) 10
0.096 (358) 100.0
(56.6, 100.0)
Turkey 0
0.029 (238) 6
0.026 (232) 100.0
(22.2, 100.0)
United States 51
4.861 (16,735) 664
4.678 (16,785) 92.6
(90.2, 94.6)
Notes: Confirmed cases were determined by Reverse Transcription -Polymerase Chain Reaction (RT -PCR) and at least 1 symptom
consistent with COVID -19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss o f taste or smell; sore throat; diarrhea; vomiting)
Included confirmed cases in participants 12 through 15 years of age: 0 in the COMIRNATY group; 18 in the placebo group
* Participants who had no evidence of past SARS -CoV-2 infection (i e, N-binding antibody [serum] negative at Visit 1 and
SARS -CoV -2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after D ose 2 were included in the analysis
a N = N umber of participants in the specified group
b n1 = Number of participants meeting the endpoint definition
c Total surveillance time in 1000 person -years for the given endpoint across all participants withi n each group at risk for the endpoint
Time period for COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period
d n2 = Number of participants at risk for the endpoint
e Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time
f All others = American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific Islander, multiracial, and not reported race
categories
FDA-CBER-2021-5683-0651503
24
The updated subgroup analyses of vaccine efficacy by risk status in participants are presented in Table 12 and Table 13. Table 12: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Risk Status – Participants Without Evidence of Infection * Prior to 7 Days After Dose 2 – Evaluable Efficacy
(7 Days) Population Dur ing the Placebo -Controlled Follow- up Period
Subgroup COMIRNATY
Na=20,998
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=21,096
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
First COVID -19 occurrence from
7 days after Dose 2f 77
6.247 (20,712) 850
6.003 (20,713) 91.3
(89.0, 93.2)
At riskg
Yes 35
2.797 (9167) 401
2.681 (9136) 91.6
(88.2, 94.3)
No 42
3.450 (11,545) 449
3.322 (11,577) 91.0
(87.6, 93.6)
Age group (years) and risk status
16 through 64 and not at risk 41
2.776 (8887) 385
2.661 (8886) 89.8
(85.9, 92.8)
16 through 64 and at risk 29
2.083 (6632) 325
1.993 (6629) 91.5
(87.5, 94.4)
65 and older and not at risk 1
0.553 (1870) 53
0.546 (1922) 98.1
(89.2, 100.0)
65 and older and at risk 6
0.680 (2322) 71
0.656 (2304) 91.8
(81.4, 97.1)
Obeseh
Yes 27
2.103 (6796) 314
2.050 (6875) 91.6
(87.6, 94.6)
No 50
4.143 (13,911) 536
3.952 (13,833) 91.1
(88.1, 93.5)
Age group (years) and obesity status
16 through 64 and not obese 46
3.178 (10,212) 444
3.028 (10,166) 90.1
(86.6, 92.9)
16 through 64 and obese 24
1.680 (5303) 266
1.624 (5344) 91.3
(86.7, 94.5)
65 and older and not obese 4
0.829 (2821) 79
0.793 (2800) 95.2
(87.1, 98.7)
65 and older and obese 3
0.404 (1370) 45
0.410 (1426) 93.2
(78.9, 98.7)
Note: Confirmed cases were determined by Reverse Transcription -Polymerase Chain Reaction (RT -PCR) and at least 1 symptom
consistent with COVID -19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting)
* Participants who had no evidence of past SARS -CoV-2 infection (i e , N -binding antibody [serum] negative at Visit 1 and
SARS -CoV -2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis
a N = N umber of participants in the specified group
b n1 = Number of participants meeting the endpoint definition
FDA-CBER-2021-5683-0651504
25 Subgroup COMIRNATY
Na=20,998
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=21,096
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
c Total surveillance time in 1000 person -years for the given endpoint across all participants within each group at risk for the endpoint
Time period for COVID- 19 case accrual is from 7 days after Dose 2 to the end of the surveillance period
d n2 = Number of participants at risk for the endpoint
e Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for
surveillance time
f Included confirmed cases in participants 12 through 15 years of age: 0 in the COMIRNATY group; 16 in the placebo group
g At risk is defined as having at least 1 of the Charlson Comorbidity Index (CMI) category or obesity (BMI ≥30 kg/m2 or BMI ≥95th
percentile [12 through 15 years of age] )
h Obese is defined as BMI ≥30 kg/m2 For 12 through 15 years age group, obesity is defined as a BMI at or above the 95th percentile
Refer to the CDC growth charts at https://www cdc gov/growthcharts/html charts/bmiagerev htm
Table 13: Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by R isk Status –
Participants With or Without* Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable
Efficacy (7 Days) Population During the Placebo -Controlled Follow -up Period
Subgroup COMIRNATY
Na=22,166
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=22,320
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
First COVID -19 occurrence from
7 days after Dose 2f 81
6.509 (21,642) 873
6.274 (21,689) 91.1
(88.8, 93.0)
At riskg
Yes 36
2.925 (9601) 410
2.807 (9570) 91.6
(88.1, 94.2)
No 45
3.584 (12,041) 463
3.466 (12,119) 90.6
(87.2, 93.2)
Age group (years) and risk status
16 through 64 and not at risk 44
2.887 (9254) 397
2.779 (9289) 89.3
(85.4, 92.4)
16 through 64 and at risk 30
2.186 (6964) 330
2.100 (6980) 91.3
(87.3, 94.2)
65 and older and not at risk 1
0.566 (1920) 55
0.559 (1966) 98.2
(89.6, 100.0)
65 and older and at risk 6
0.701 (2395) 73
0.672 (2360) 92.1
(82.0, 97.2)
Obeseh
Yes 28
2.207 (7139) 319
2.158 (7235) 91.4
(87.4, 94.4)
No 53
4.301 (14,497) 554
4.114 (14,448) 90.8
(87.9, 93.2)
Age group (years) and obes ity status
16 through 64 and not obese 49
3.303 (10,629) 458
3.158 (10,614) 89.8
(86.2, 92.5)
16 through 64 and obese 25
1.768 (5584) 269
1.719 (5649) 91.0
(86.4, 94.3)
FDA-CBER-2021-5683-0651505
26 Table 13: Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by R isk Status –
Participants With or Without* Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable
Efficacy (7 Days) Population During the Placebo -Controlled Follow -up Period
Subgroup COMIRNATY
Na=22,166
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=22,320
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
65 and older and not obese 4
0.850 (2899) 82
0.811 (2864) 95.3
(87.6, 98.8)
65 and older and obese 3
0.417 (1415) 46
0.420 (1462) 93.4
(79.5, 98.7)
Note: Confirmed cases were determined by Reverse Transcription -Polymerase Chain Reaction (RT -PCR) and at least 1 symptom
consistent with COVID -19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting)
* Participants who had no evidence of past SARS -CoV-2 infection (i e , N -binding antibody [serum] negative at Visit 1 and
SARS -CoV -2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were i ncluded in the analysis
a N = number of participants in the specified group
b n1 = Number of participants meeting the endpoint definition
c Total surveillance time in 1000 person -years for the given endpoint across all participants within each group at risk for the endpoint
Time period for COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period
d n2 = Number of participants at risk for the endpoint
e Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for
surveillance time
f Included confirmed cases in participants 12 through 15 years of age: 0 in the COMIRNATY group; 18 in the placebo group
g At risk is defined as having at least 1 of the C harlson Comorbidity Index (CMI) category or obesity (BMI ≥30 kg/m2 or BMI ≥95th
percentile [12 through 15 years of age] )
h Obese is defined as BMI ≥30 kg/m2 For th e 12 through 15 years of age group, obesity is defined as a BMI at or above the 95th
percentile Refer to the CDC growth charts at https://www cdc gov/growthcharts/html charts/bmiagerev htm
Efficacy Against S evere COVID -19
Updated efficacy analyses of secondary efficacy endpoints supported benefit of COMIRNATY in preventing
severe COVID -19. Vaccine efficacy against severe COVID -19 is presented only for participants with or without
prior SARS -CoV-2 infection (Table 14) as the COVID-19 case counts in participants without prior
SARS -CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in
both the COMIRNATY and placebo groups. Table 14: Vaccine Efficacy – First Severe COVID- 19 Occurrence in Participants With or Without* Prior
SARS -CoV-2 Infection Based on FDA
† or Centers for Disease Control and Prevention (CDC)‡
Definition After Dose 1 or From 7 Days After Dose 2 in the Placebo -Controlled Follow -up
Vaccine Efficacy – First Severe COVID -19 Occurrence Based on FDA Definition
COMIRNATY
Cases
n1a
Surveillance Time (n2b) Placebo
Cases
n1a
Surveillance Time (n2b) Vaccine Efficacy %
(95% CIc)
After Dose 1d 1
8.439e (22,505) 30
8.288e (22,435) 96.7
(80.3, 99.9)
7 days after Dose 2f 1
6.522g (21,649) 21
6.404g (21,730) 95.3
(70.9, 99.9)
FDA-CBER-2021-5683-0651506