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Table.A.1 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population,
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
RT-PCR NP Swab Results and Serostatus
at Different Time Points BNT162b2
(Na=21047)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
Pre-Dose 1 SARS -CoV -2 RT -PCR (NP swab)
Positive 1
0.040
(127) 1
0.047
(154) -17.9
(-9154.3, 98.5)
Negative 79
6.284
(20356) 853
6.048
(20395) 91.1
(88.8, 93.0)
Unknown 1
0.015
(50) 0
0.015
(46) -∞
(NA, NA)
Pre-Dose 2 SARS -CoV -2 RT -PCR (NP swab)
Positive 1
0.030
(101) 1
0.037
(130) -24.7
(-9685.9, 98.4)
Negative 80
6.293
(20376) 849
6.061
(20423) 90.9
(88.6, 92.9)
Unknown 0
0.017
(56) 4
0.013
(42) 100.0
(-11.3, 100.0)
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Table.A.1 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population,
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
RT-PCR NP Swab Results and Serostatus
at Different Time Points BNT162b2
(Na=21047)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
Subjects with negative PCR Pre -dose 1 and positive PCR
Pre-dose 2
Subjects with documented COVID -19 symptoms
between Dose 1 and 2 0
0.000
(0) 0
0.001
(2)
Subjects with no documented COVID -19 symptoms
between Dose 1 and 2 0
0.016
(58) 1
0.019
(71)
Pre-Dose 1 N -binding antibody
Positive 3
0.169
(550) 5
0.181
(594) 36.0
(-228.7, 90.1)
Negative 78
6.147
(19896) 847
5.910
(19927) 91.1
(88.8, 93.1)
Unknown 0
0.023
(87) 2
0.019
(74) 100.0
(-348.8, 100.0)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NA = Not applicable; NP = nasopharyngeal;
RT-PCR = reverse transcription –polymerase chain reaction; SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2;
VE = vaccine efficacy.
a. N = number of subjects in the specified group.
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Table.A.1 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population,
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
RT-PCR NP Swab Results and Serostatus
at Different Time Points BNT162b2
(Na=21047)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.A.2 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Dose 2 All -Available Efficacy Population,
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
RT-PCR NP Swab Results and Serostatus
at Different Time Points BNT162b2
(Na=21552)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21528)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
Pre-Dose 1 SARS -CoV -2 RT -PCR (NP swab)
Positive 1
0.041
(132) 1
0.048
(155) -15.4
(-8959.5, 98.5)
Negative 80
6.422
(20836) 869
6.144
(20697) 91.2
(88.9, 93.1)
Unknown 1
0.016
(51) 0
0.016
(49) -∞
(NA, NA)
Pre-Dose 2 SARS -CoV -2 RT -PCR (NP swab)
Positive 1
0.031
(105) 1
0.038
(131) -22.3
(-9503.8, 98.4)
Negative 81
6.431
(20857) 865
6.156
(20723) 91.0
(88.7, 93.0)
Unknown 0
0.017
(57) 4
0.013
(47) 100.0
(-16.4, 100.0)
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Table.A.2 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Dose 2 All -Available Efficacy Population,
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
RT-PCR NP Swab Results and Serostatus
at Different Time Points BNT162b2
(Na=21552)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21528)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
Subjects with negative PCR Pre -dose 1 and positive PCR
Pre-dose 2
Subjects with documented COVID -19 symptoms
between Dose 1 and 2 0
0.000
(0) 0
0.001
(2)
Subjects with no documented COVID -19 symptoms
between Dose 1 and 2 0
0.016
(61) 1
0.020
(72)
Pre-Dose 1 N -binding antibody
Positive 3
0.173
(563) 5
0.185
(608) 35.8
(-229.9, 90.0)
Negative 79
6.283
(20367) 863
6.002
(20218) 91.3
(89.0, 93.1)
Unknown 0
0.023
(89) 2
0.019
(75) 100.0
(-344.1, 100.0)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NA = Not applicable; NP = nasopharyngeal;
RT-PCR = reverse transcription –polymerase chain reaction; SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2;
VE = vaccine efficacy.
a. N = number of subjects in the specified group.
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Table.A.2 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Dose 2 All -Available Efficacy Population,
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
RT-PCR NP Swab Results and Serostatus
at Different Time Points BNT162b2
(Na=21552)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21528)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.D Disposition of Participants 16 Years of Age and Older, Phase 2/3 Subjects,
Efficacy Population (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
na (%) Placebo
na (%) Total
na (%)
Randomizedb 22085 (100.0) 22080 (100.0) 44165 (100.0)
Dose 1 all -available efficacy population 22009 (99.7) 22008 (99.7) 44017 (99.7)
Subjects without evidence of infection before Dose 1 21172 (95.9) 21168 (95.9) 42340 (95.9)
Subjects excluded from Dose 1 all -available efficacy population 76 (0.3) 72 (0.3) 148 (0.3)
Reason for exclusionc
Did not receive at least 1 vaccination 55 (0.2) 50 (0.2) 105 (0.2)
Data considered potentially unreliable due to lack of PI oversight
identified as significant quality event 21 (0.1) 22 (0.1) 43 (0.1)
Dose 2 all -available efficacy population 21648 (98.0) 21624 (97.9) 43272 (98.0)
Subjects without evidence of infection prior to 7 days after Dose 2 20536 (93.0) 20487 (92.8) 41023 (92.9)
Subjects excluded from Dose 2 all -available efficacy population 437 (2.0) 456 (2.1) 893 (2.0)
Reason for exclusionc
Did not receive 2 vaccinations 374 (1.7) 430 (1.9) 804 (1.8)
Data considered potentially unreliable due to lack of PI oversight
identified as significant quality event 21 (0.1) 22 (0.1) 43 (0.1)
Unblinded prior to 7 days after Dose 2 44 (0.2) 11 (0.0) 55 (0.1)
Evaluable efficacy (7 days) population 21136 (95.7) 21300 (96.5) 42436 (96.1)
Subjects without evidence of infection prior to 7 days after Dose 2 20064 (90.8) 20197 (91.5) 40261 (91.2)
Subjects excluded from evaluable efficacy (7 days) population 949 (4.3) 780 (3.5) 1729 (3.9)
Reason for exclusionc
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Table.D Disposition of Participants 16 Years of Age and Older, Phase 2/3 Subjects,
Efficacy Population (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
na (%) Placebo
na (%) Total
na (%)
Randomized but did not meet all eligibility criteria 32 (0.1) 30 (0.1) 62 (0.1)
Data considered potentially unreliable due to lack of PI oversight
identified as significant quality event 21 (0.1) 22 (0.1) 43 (0.1)
Did not receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19- 42 days after Dose 1) 718 (3.3) 729 (3.3) 1447 (3.3)
Unblinded prior to 7 days after Dose 2 44 (0.2) 11 (0.0) 55 (0.1)
Had other important protocol deviations on or prior to 7 days after Dose 2 240 (1.1) 58 (0.3) 298 (0.7)
Note: HIV -positive subjects are included in this summary but not included in the analyses of the overall study objectives.
a. n = Number of subjects with the specified characteristic.
b. These values are the denominators for the percentage calcul ations.
c. Subjects may have been excluded for more than 1 reason.
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Table.F Demographics and Other Baseline Characteristics, Participants 16 Years of Age and Older,
With or Without Evidence of Infection Prior to 7 Days After Dose 2, Evaluable Efficacy Population
(Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=21136)
nb (%) Placebo
(Na=21300)
nb (%) Total
(Na=42436)
nb (%)
Sex: Female 10280 (48.6) 10579 (49.7) 20859 (49.2)
Sex: Male 10856 (51.4) 10721 (50.3) 21577 (50.8)
Age at Vaccination: Mean years (SD) 49.8 (15.99) 49.7 (16.03) 49.7 (16.01)
Age at Vaccination: Median (years) 51.0 51.0 51.0
Age at Vaccination: Min, max (years) (16, 89) (16, 91) (16, 91)
Age Group: 16 to <18 years 370 (1.8) 362 (1.7) 732 (1.7)
Age Group: 18 to 55 years 12120 (57.3) 12252 (57.5) 24372 (57.4)
Age Group: >55 years 8646 (40.9) 8686 (40.8) 17332 (40.8)
Age Group: ≥65 years 4407 (20.9) 4429 (20.8) 8836 (20.8)
Race: American Indian or Alaska Native 204 (1.0) 190 (0.9) 394 (0.9)
Race: Asian 929 (4.4) 924 (4.3) 1853 (4.4)
Race: Black or African American 2009 (9.5) 2036 (9.6) 4045 (9.5)
Race: Native Hawaiian or Other Pacific Islander 56 (0.3) 32 (0.2) 88 (0.2)
Race: White 17304 (81.9) 17487 (82.1) 34791 (82.0)
Race: Multiracial 545 (2.6) 519 (2.4) 1064 (2.5)
Race: Not reported 89 (0.4) 112 (0.5) 201 (0.5)
Ethnicity: Hispanic or Latino 5403 (25.6) 5409 (25.4) 10812 (25.5)
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Table.F Demographics and Other Baseline Characteristics, Participants 16 Years of Age and Older,
With or Without Evidence of Infection Prior to 7 Days After Dose 2, Evaluable Efficacy Population
(Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=21136)
nb (%) Placebo
(Na=21300)
nb (%) Total
(Na=42436)
nb (%)
Ethnicity: Not Hispanic or Latino 15628 (73.9) 15778 (74.1) 31406 (74.0)
Ethnicity: Not reported 105 (0.5) 113 (0.5) 218 (0.5)
Obesity: Yesc 7239 (34.2) 7386 (34.7) 14625 (34.5)
Obesity: No 13897 (65.8) 13914 (65.3) 27811 (65.5)
Comorbidities: Yesd 9712 (46.0) 9736 (45.7) 19448 (45.8)
Comorbidities: No 11424 (54.0) 11564 (54.3) 22988 (54.2)
Baseline evidence of prior SARS -CoV -2 infection: Negativef 20365 (96.4) 20511 (96.3) 40876 (96.3)
Baseline evidence of prior SARS -CoV -2 infection: Positivee 627 (3.0) 669 (3.1) 1296 (3.1)
Baseline evidence of prior SARS -CoV -2 infection: Missing 144 (0.7) 120 (0.6) 264 (0.6)
Country: Argentina 2686 (12.7) 2710 (12.7) 5396 (12.7)
Country: Brazil 1437 (6.8) 1432 (6.7) 2869 (6.8)
Country: Germany 240 (1.1) 243 (1.1) 483 (1.1)
Country: South Africa 391 (1.8) 392 (1.8) 783 (1.8)
Country: Turkey 241 (1.1) 238 (1.1) 479 (1.1)
Country: United States of America 16141 (76.4) 16285 (76.5) 32426 (76.4)
Abbreviation: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
Note: HIV -positive subjects are included in this summary but not included in the analyses of the overall study objectives.
a. N = number of subjects in the specified group, or the total sample. This value is the denominator for the percentage calculat ions.
b. n = Number of subjects with the specified characteristic.
c. Subjects who had BMI ≥30 kg/m2.
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Table.F Demographics and Other Baseline Characteristics, Participants 16 Years of Age and Older,
With or Without Evidence of Infection Prior to 7 Days After Dose 2, Evaluable Efficacy Population
(Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=21136)
nb (%) Placebo
(Na=21300)
nb (%) Total
(Na=42436)
nb (%)
d. Number of subjects who have 1 or more comorbidities that increase the risk of severe COVID -19 disease: defined as subjects who had at le ast one of
the Charlson comorbidity index category or BMI ≥30 kg/m2.
e. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19.
f. Negative N -binding antibody result and negative NAAT result at Visit 1 and no medical history of COVID -19.
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Table.G Final Analysis of Efficacy of BNT162b2 Against Confirmed COVID -19 From 7 Days After Dose 2
in Participants Without Evidence of Prior SARS- CoV -2 Infection
– Evaluable Efficacy Population, 16 Years and Older (Data Cutoff November 2020)
Pre-specified Age Group BNT162b2
(Na=18152)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=18283)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e Met Predefined Success Criterion
All participants 8
2.214
(17397) 162
2.222
(17498) 95.0
(90.0, 97.9) NA
16 to 55 years 5
1.234
(9897) 114
1.239
(9955) 95.6
(89.4, 98.6) NA
>55 years and older 3
0.980
(7500) 48
0.983
(7543) 93.7
(80.6, 98.8) NA
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
Note: Subjects who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS -CoV -2 infection (ie, 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 prio r to 7 days after Dose 2 were included in the analysis.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.H Updated Efficacy of BNT162b2 Against Confirmed COVID -19 From 7 Days After Dose 2
in Participants Without Evidence of Prior SARS- CoV -2 Infection
– Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Pre-specified Age Group BNT162b2
(Na=19993)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=20118)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
All participants 77
6.092
(19711) 833
5.857
(19741) 91.1
(88.8, 93.1)
16 to 55 years 52
3.593
(11517) 568
3.439
(11533) 91.2
(88.3, 93.5)
>55 years and older 25
2.499
(8194) 265
2.417
(8208) 90.9
(86.2, 94.2)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
Note: Subjects who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS -CoV -2 infection (ie, 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 prio r to 7 days after Dose 2 were included in the analysis.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.I Updated Efficacy of BNT162b2 Against Confirmed COVID -19 From 7 Days After Dose 2
in Participants With or Without Evidence of Prior SARS- CoV-2 Infection
– Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Pre-specified Age Group BNT162b2
(Na=21047)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
All participants 81
6.340
(20533) 854
6.110
(20595) 90.9
(88.5, 92.8)
16 to 55 years 56
3.766
(12088) 584
3.619
(12142) 90.8
(87.9, 93.1)
>55 years and older 25
2.573
(8445) 270
2.492
(8453) 91.0
(86.5, 94.3)
Abbreviations: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint . Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method ad justed for surveillance time.
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
First COVID -19 occurrence from 7 days after Dose 2
Overall 81
6.340
(20533) 854
6.110
(20595) 90.9
(88.5, 92.8)
Age group: 16 to <18 years 0
0.065
(365) 11
0.061
(355) 100.0
(62.4, 100.0)
Age group: 18 to <65 years 74
5.008
(15853) 715
4.817
(15914) 90.0
(87.3, 92.3)
Age group: ≥65 years 7
1.267
(4315) 128
1.232
(4326) 94.7
(88.7, 97.9)
Age group: 65 to 74 years 6
1.021
(3450) 102
0.992
(3468) 94.3
(87.1, 98.0)
Age group: ≥75 years 1
0.246
(865) 26
0.240
(858) 96.2
(77.2, 99.9)
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
At risk: Yesf 36
2.887
(9359) 402
2.772
(9340) 91.4
(87.9, 94.1)
At risk: No 45
3.453
(11174) 452
3.338
(11255) 90.4
(86.9, 93.1)
Age group and Risk: 16 -64 and not at risk 44
2.887
(9254) 397
2.779
(9289) 89.3
(85.4, 92.4)
Age group and Risk: 16 -64 and at risk 30
2.186
(6964) 329
2.100
(6980) 91.2
(87.3, 94.2)
Age group and Risk: ≥65 and not at risk 1
0.566
(1920) 55
0.559
(1966) 98.2
(89.6, 100.0)
Age group and Risk: ≥65 and at risk 6
0.701
(2395) 73
0.672
(2360) 92.1
(82.0, 97.2)
Obese: Yesg 28
2.185
(6999) 314
2.139
(7111) 91.3
(87.1, 94.3)
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
Obese: No 53
4.153
(13528) 540
3.970
(13478) 90.6
(87.5, 93.1)
Age group and obese:16 -64 and not obese 49
3.303
(10629) 458
3.158
(10614) 89.8
(86.2, 92.5)
Age group and obese:16 -64 and obese 25
1.768
(5584) 268
1.719
(5649) 90.9
(86.3, 94.2)
Age group and obese: ≥65 and not obese 4
0.850
(2899) 82
0.811
(2864) 95.3
(87.6, 98.8)
Age group and obese: ≥65 and obese 3
0.417
(1415) 46
0.420
(1462) 93.4
(79.5, 98.7)
Sex: Female 37
3.051
(9985) 455
3.013
(10241) 92.0
(88.8, 94.4)
Sex: Male 44
3.289
(10548) 399
3.097
(10354) 89.6
(85.8, 92.6)
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
Ethnicity: Hispanic or Latino 32
1.841
(5280) 240
1.777
(5266) 87.1
(81.3, 91.4)
Ethnicity: Not Hispanic or Latino 48
4.466
(15149) 614
4.300
(15220) 92.5
(89.9, 94.5)
Ethnicity: Not reported 1
0.032
(104) 0
0.034
(109) -∞
(NA, NA)
Race: American Indian or Alaska native 0
0.043
(196) 3
0.038
(180) 100.0
(-116.0, 100.0)
Race: Asian 3
0.258
(907) 24
0.247
(896) 88.0
(60.6, 97.7)
Race: Black or African American 4
0.602
(1909) 49
0.591
(1928) 92.0
(78.1, 97.9)
Race: Native Hawaiian or other Pacific Islander 0
0.016
(54) 1
0.008
(31) 100.0
(-1947.9, 100.0)
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
Race: White 69
5.234
(16846) 749
5.054
(16952) 91.1
(88.6, 93.2)
Race: Multiracial 5
0.160
(538) 22
0.140
(503) 80.1
(46.1, 94.1)
Race: Not reported 0
0.027
(83) 6
0.031
(105) 100.0
(1.4, 100.0)
Baseline SARS -CoV -2 Status:Positiveh 3
0.183
(593) 6
0.195
(643) 46.7
(-149.5, 91.4)
Baseline SARS -CoV -2 Status:Negativei 77
6.119
(19805) 846
5.883
(19838) 91.2
(88.9, 93.2)
Baseline SARS -CoV -2 Status:Unknown 1
0.038
(135) 2
0.033
(114) 56.9
(-728.5, 99.3)
Country: Argentina 16
1.033
(2655) 110
1.017
(2670) 85.7
(75.7, 92.1)
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
Country: Brazil 14
0.441
(1419) 82
0.408
(1401) 84.2
(71.9, 91.7)
Country: Germany 0
0.047
(237) 1
0.048
(243) 100.0
(-3868.6, 100.0)
Country: South Africa 0
0.099
(358) 10
0.096
(358) 100.0
(56.6, 100.0)
Country: Turkey 0
0.029
(238) 6
0.026
(232) 100.0
(22.2, 100.0)
Country: United States 51
4.692
(15626) 645
4.515
(15691) 92.4
(89.9, 94.4)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearso n method adjusted for surveillance time.
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Table.J Subgroup Analyses of Updated Second Primary Endpoint: First COVID -19 Occurrence From 7 Days After Dose 2, by
Subgroup, Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2,
Evaluable Efficacy Population, 16 Years and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=21047)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=21210)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
f. Includes subjects who had at least one of the Charlson Comorbidity Index (CMI) category or obesity (BMI ≥30 kg/m2).
g. Subjects (≥16 Years of age) who had BMI ≥30 kg/m2.
h. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19.
i. Negative N -binding antibody result and negative NAAT result at Visit 1 and no medical history of COVID -19.
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Table.K Demographic Characteristics, Participants 16 Years of Age and Older, With Protocol -Defined Case (Without Evidence of
Infection Prior to 7 Days After Dose 2) (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=77)
nb (%) Placebo
(Na=833)
nb (%) Total
(Na=910)
nb (%)
Age at Vaccination: Mean years (SD) 46.9 (14.79) 47.1 (15.58) 47.1 (15.51)
Age at Vaccination: Median (years) 50.0 47.0 48.0
Age at Vaccination: Min, max (years) (19, 77) (16, 88) (16, 88)
Age Group: 16 to <18 years 0 10 (1.2) 10 (1.1)
Age Group: 18 to <65 years 70 (90.9) 699 (83.9) 769 (84.5)
Age Group: ≥65 years 7 (9.1) 124 (14.9) 131 (14.4)
Age Group: ≥65 to <75 years 6 (7.8) 98 (11.8) 104 (11.4)
Age Group: ≥75 years 1 (1.3) 26 (3.1) 27 (3.0)
Race: American Indian or Alaska Native 0 3 (0.4) 3 (0.3)
Race: Asian 3 (3.9) 23 (2.8) 26 (2.9)
Race: Black or African American 4 (5.2) 48 (5.8) 52 (5.7)
Race: Native Hawaiian or Other Pacific Islander 0 1 (0.1) 1 (0.1)
Race: White 67 (87.0) 730 (87.6) 797 (87.6)
Race: Multiracial 3 (3.9) 22 (2.6) 25 (2.7)
Race: Not reported 0 6 (0.7) 6 (0.7)
Sex: Female 35 (45.5) 444 (53.3) 479 (52.6)
Sex: Male 42 (54.5) 389 (46.7) 431 (47.4)
Ethnicity: Hispanic or Latino 29 (37.7) 236 (28.3) 265 (29.1)
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Table.K Demographic Characteristics, Participants 16 Years of Age and Older, With Protocol -Defined Case (Without Evidence of
Infection Prior to 7 Days After Dose 2) (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=77)
nb (%) Placebo
(Na=833)
nb (%) Total
(Na=910)
nb (%)
Ethnicity: Not Hispanic or Latino 47 (61.0) 597 (71.7) 644 (70.8)
Ethnicity: Not reported 1 (1.3) 0 1 (0.1)
Comorbidities: Yesc 35 (45.5) 395 (47.4) 430 (47.3)
Comorbidities: No 42 (54.5) 438 (52.6) 480 (52.7)
Obesity: Yesd 27 (35.1) 310 (37.2) 337 (37.0)
Obesity: No 50 (64.9) 523 (62.8) 573 (63.0)
Country: Argentina 15 (19.5) 108 (13.0) 123 (13.5)
Country: Brazil 12 (15.6) 80 (9.6) 92 (10.1)
Country: Germany 0 1 (0.1) 1 (0.1)
Country: South Africa 0 9 (1.1) 9 (1.0)
Country: Turkey 0 5 (0.6) 5 (0.5)
Country: United States 50 (64.9) 630 (75.6) 680 (74.7)
a. N = number of subjects in the specified group, or the total sample. This value is the denominator for the percentage calculat ions.
b. n = Number of subjects with the specified characteristic.
c. Number of subjects who have 1 or more comorbidities that increase the risk of severe COVID -19 disease: defined as subjects who had at least one of
the Charlson comorbidity index category or BMI ≥30 kg/m2.
d. Subjects who had BMI ≥30 kg/m2.
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Table.L Updated Vaccine Efficacy: First COVID -19 Occurrence From 7 Days After Dose 2, by Comorbidity Status,
Among Participants Without Evidence of Infection Prior to 7 Days After Dose 2, Evaluable Efficacy Population.
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19993) Placebo
(Na=20118)
Efficacy Endpoint
Subgroup Cases n1b
Surveillance Timec
(n2d) Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
First COVID -19 occurrence from 7 days after Dose 2
Overall 77
6.092
(19711) 833
5.857
(19741) 91.1
(88.8, 93.1)
Comorbidity
No comorbidity 42
3.329
(10757) 438
3.207
(10808) 90.8
(87.3, 93.4)
Any comorbidityf 35
2.763
(8954) 395
2.650
(8933) 91.5
(88.0, 94.2)
Any malignancy 3
0.228
(770) 27
0.213
(747) 89.6
(66.3, 98.0)
Cardiovascular 3
0.172
(584) 22
0.159
(555) 87.4
(58.1, 97.6)
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Table.L Updated Vaccine Efficacy: First COVID -19 Occurrence From 7 Days After Dose 2, by Comorbidity Status,
Among Participants Without Evidence of Infection Prior to 7 Days After Dose 2, Evaluable Efficacy Population.
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19993) Placebo
(Na=20118)
Efficacy Endpoint
Subgroup Cases n1b
Surveillance Timec
(n2d) Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
Chronic pulmonary disease 8
0.474
(1582) 66
0.443
(1562) 88.7
(76.3, 95.3)
Diabetes 9
0.465
(1528) 60
0.444
(1513) 85.7
(70.9, 93.7)
Obese (≥30.0 kg/m2) 27
2.083
(6673) 310
2.034
(6770) 91.5
(87.4, 94.5)
Hypertension 15
1.481
(4900) 190
1.427
(4895) 92.4
(87.1, 95.8)
Diabetes (including gestational diabetes) 9
0.468
(1537) 62
0.447
(1527) 86.1
(71.9, 93.9)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
Note: Subjects who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS -CoV -2 infection (ie, 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 prio r to 7 days after Dose 2 were included in the analysis.
a. N = number of subjects in the specified group.
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Table.L Updated Vaccine Efficacy: First COVID -19 Occurrence From 7 Days After Dose 2, by Comorbidity Status,
Among Participants Without Evidence of Infection Prior to 7 Days After Dose 2, Evaluable Efficacy Population.
Participants 16 Years of Age and Older (Data Cutoff March 13, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19993) Placebo
(Na=20118)
Efficacy Endpoint
Subgroup Cases n1b
Surveillance Timec
(n2d) Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
f. Subject who had 1 or more comorbidities that increase the risk of severe COVID -19 disease: defined as subjects who had at least one of the Charlson
comorbidity i ndex category or BMI ≥30 kg/m2.
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Table.M First Severe COVID -19 Occurrence From 7 Days After Dose 2 – Subjects Without Evidence of Infection
Prior to 7 Days After Dose 2 – Participants 16 Years of Age and Older –
Evaluable Efficacy Population (Data Cutoff March 13, 2021)
Secondary Efficacy Endpoint BNT162b2
(Na=19993)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=20118)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy
%
(95% CI)e
First severe COVID -19 occurrence from 7 days after Dose 2 in participants without
evidence of prior SARS -CoV -2 infection 1
6.103
(19711) 21
5.971
(19741) 95.3
(71.0, 99.9)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
Note: Subjects who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS -CoV -2 infection (ie, N -binding
antibody [serum] negative at Visit 1 and SARS -CoV -2 not detected by NAAT [nas al 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 subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.N First Severe COVID -19 Occurrence After Dose 1 – Participants 16 Years of Age and Older –
Dose 1 All -Available Efficacy Population (Data Cutoff March 13, 2021)
Secondary Efficacy Endpoint BNT162b2
(Na=21909)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21908)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
First severe case occurrence after Dose 1 1
8.181
(21385) 30
8.032
(21316) 96.7
(80.3, 99.9)
After Dose 1 to before Dose 2 0
1.285
(21385) 6
1.293
(21316) 100.0
(14.6, 100.0)
Dose 2 to 7 days after Dose 2 0
0.403
(21056) 1
0.402
(20962) 100.0
(-3783.8, 100.0)
≥7 Days after Dose 2 1
6.493
(21029) 23
6.337
(20940) 95.8
(73.9, 99.9)
Abbreviation: VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from Dose 1 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.O Primary Efficacy Endpoint – Participants 16 Years of Age and Older –
Dose 1 All -Available Efficacy Population (Data Cutoff March 13, 2021)
Efficacy Endpoint Subgroup BNT162b2
(Na=21909)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=21908)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
First COVID -19 occurrence after Dose 1 128
8.155
(21385) 998
7.874
(21315) 87.6
(85.1, 89.8)
After Dose 1 to before Dose 2 43
1.273
(21385) 98
1.266
(21315) 56.4
(37.0, 70.3)
Dose 2 to 7 days after Dose 2 3
0.403
(21049) 30
0.401
(20952) 90.0
(68.0, 98.1)
≥7 Days after Dose 2 82
6.479
(21019) 870
6.207
(20901) 91.0
(88.7, 92.9)
Abbreviation: VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from Dose 1 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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