Document text
3
• Before dilution invert vaccine vial gently 10 times.
• Do not shake.
• Inspect the liquid in the vial prior to dilution. The
liquid is a white to off-white suspension and may contain white to off-white opaque amorphous
particles .
• Do not use if liquid is discolored or if other particles are observed.
DILUTION
• ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent.
• Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21 -gauge or narrower
needle).
• Cleanse the vaccine vial stopper with a single- use
antiseptic swab.
• Add 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial .
• Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
FDA-CBER-2021-5683-0651641
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 a single vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
• Administer immediately.
FDA-CBER-2021-5683-0651642
9 COMIRNATY
Dose 1
Na=2899
nb (%) Placebo
Dose 1
Na=2908
nb (%) COMIRNATY
Dose 2
Na=2682
nb (%) Placebo
Dose 2
Na=2684
nb (%)
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)
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 Participants
with chronic, stable HIV infection were excluded
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; Moderate: 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
FDA-CBER-2021-5683-0651647
10 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 Participants
with chronic, stable HIV infection were excluded
a N = Number 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, 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*
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
FDA-CBER-2021-5683-0651648
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 (%)
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)
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 Participants
with chronic, stable HIV infection were excluded
a N = Number 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 participants with the specified reaction
FDA-CBER-2021-5683-0651649
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 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 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 act ivity; 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-2021-5683-0651651
23 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
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 12 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, Nbinding 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 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, Asian, Native Hawaiian or other Pacific Islander, multiracial, and not reported race
categories
FDA-CBER-2021-5683-0651661
24 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
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)
FDA-CBER-2021-5683-0651662
25 Subgroup COMIRNATY
Na=22,166
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=22,320
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
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 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, Nbinding 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 p eriod 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 Pears on 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
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
FDA-CBER-2021-5683-0651663
26 Subgroup COMIRNATY
Na=20,998
Cases
n1b
Surveillance Timec (n2d) Placebo
Na=21,096
Cases
n1b
Surveillance Timec (n2d) Vaccine Efficacy %
(95% CI)e
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
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 Risk 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)
FDA-CBER-2021-5683-0651664
27 Table 13: Vaccine Efficacy First COVID 19 Occurrence From 7 Days After Dose 2, by Risk 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
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)
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 a ny 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 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 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 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
FDA-CBER-2021-5683-0651665