Document text
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=21047) Placebo
(Na=21210)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (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 (years)
16 to 55 56 3.766 (12088) 584 3.619 (12142) 90.8 (87.9, 93.1)
>55 25 2.573 (8445) 270 2.492 (8453) 91.0 (86.5, 94.3)
≥65 7 1.267 (4315) 128 1.232 (4326) 94.7 (88.7, 97.9)
16 to 17 0 0.065 (365) 11 0.061 (355) 100.0 (62.4, 100.0)
16 to 25 10 0.511 (1734) 84 0.498 (1740) 88.4 (77.6, 94.6)
16 to 64 74 5.073 (16218) 726 4.879 (16269) 90.2 (87.5, 92.4)
18 to 64 74 5.008 (15853) 715 4.817 (15914) 90.0 (87.3, 92.3)
55 to 64 21 1.442 (4563) 158 1.386 (4559) 87.2 (79.8, 92.3)
65 to 74 6 1.021 (3450) 102 0.992 (3468) 94.3 (87.1, 98.0)
≥75 1 0.246 (865) 26 0.240 (858) 96.2 (77.2, 99.9)
75 to 85 1 0.244 (860) 25 0.238 (852) 96.1 (76.2, 99.9)
>85 0 0.001 (5) 1 0.001 (6) 100.0 (-4055.9, 100.0)
Sex
Male 44 3.289 (10548) 399 3.097 (10354) 89.6 (85.8, 92.6)
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651630
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=21047) Placebo
(Na=21210)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
Female 37 3.051 (9985) 455 3.013 (10241) 92.0 (88.8, 94.4)
Race
White 69 5.234 (16846) 749 5.054 (16952) 91.1 (88.6, 93.2)
Black or African American 4 0.602 (1909) 49 0.591 (1928) 92.0 (78.1, 97.9)
American Indian or Alaska Native 0 0.043 (196) 3 0.038 (180) 100.0 (-116.0, 100.0)
Asian 3 0.258 (907) 24 0.247 (896) 88.0 (60.6, 97.7)
Native Hawaiian or other Pacific Islander 0 0.016 (54) 1 0.008 (31) 100.0 (-1947.9, 100.0)
Multiracial 5 0.160 (538) 22 0.140 (503) 80.1 (46.1, 94.1)
Not reported 0 0.027 (83) 6 0.031 (105) 100.0 (1.4, 100.0)
All othersf 8 0.504 (1778) 56 0.465 (1715) 86.8 (72.2, 94.6)
Ethnicity
Hispanic/Latino 32 1.841 (5280) 240 1.777 (5266) 87.1 (81.3, 91.4)
Non-Hispanic/non -Latino 48 4.466 (15149) 614 4.300 (15220) 92.5 (89.9, 94.5)
Not reported 1 0.032 (104) 0 0.034 (109) -∞ (NA, NA)
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)
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651631
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=21047) Placebo
(Na=21210)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
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)
USA 51 4.692 (15626) 645 4.515 (15691) 92.4 (89.9, 94.4)
Prior SARS -CoV -2 Status
Positive at baselineg 3 0.183 (593) 6 0.195 (643) 46.7 (-149.5, 91.4)
Positive N -binding only 2 0.143 (466) 5 0.147 (488) 58.8 (-151.9, 96.1)
Positive NAAT only 0 0.013 (43) 1 0.014 (48) 100.0 (-3922.5, 100.0)
Positive NAAT and N -binding 1 0.027 (84) 0 0.034 (106) -∞ (NA, NA)
Negative at baseline but positive prior to 7 days after Dose 2h 0 0.011 (40) 1 0.013 (50) 100.0 (-4759.2, 100.0)
Negative prior to 7 days after Dose 2i 77 6.092 (19711) 833 5.856 (19740) 91.1 (88.8, 93.1)
Unknown 1 0.054 (189) 14 0.046 (162) 93.9 (59.9, 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.
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 accr ual 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.
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651632
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=21047) Placebo
(Na=21210)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
f. All others = American Indian or Alaska native, Asian, Native Hawaiian or other Pacific Islander, multiracial, and not reporte d race categories.
g. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID- 19.
h. Negative N -binding antibody result and negative NAAT result at Visit 1, positive NAAT result at Visit 2 or at unscheduled visit, if any, prior to 7 days
after Dose 2.
i. Negative N -binding antibody result at Visit 1, negative NAAT result at Visit 1 and Visit 2, and negative NAAT result at unscheduled visit, if any, prior to
7 days after Dose 2.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adc19ef Table Generation: 06AUG2021 (08:53)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA_Efficacy_v2/adc19ef_ve_cov_7pd2_sg_eval
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651633
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19993) Placebo
(Na=20118)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (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)
Age group (years)
16 to 55 52 3.593 (11517) 568 3.439 (11533) 91.2 (88.3, 93.5)
>55 25 2.499 (8194) 265 2.417 (8208) 90.9 (86.2, 94.2)
≥65 7 1.233 (4192) 124 1.202 (4226) 94.5 (88.3, 97.8)
16 to 17 0 0.061 (342) 10 0.057 (331) 100.0 (58.2, 100.0)
16 to 25 8 0.482 (1629) 80 0.466 (1622) 90.3 (80.0, 96.0)
16 to 64 70 4.859 (15519) 709 4.654 (15515) 90.5 (87.9, 92.7)
18 to 64 70 4.798 (15177) 699 4.597 (15184) 90.4 (87.7, 92.6)
55 to 64 21 1.399 (4426) 156 1.334 (4388) 87.2 (79.7, 92.3)
65 to 74 6 0.994 (3350) 98 0.966 (3379) 94.1 (86.6, 97.9)
≥75 1 0.239 (842) 26 0.237 (847) 96.2 (76.9, 99.9)
75 to 85 1 0.238 (837) 25 0.235 (841) 96.0 (75.9, 99.9)
>85 0 0.001 (5) 1 0.001 (6) 100.0 (-4055.9, 100.0)
Sex
Male 42 3.167 (10138) 389 2.972 (9934) 89.9 (86.0, 92.8)
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651634
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19993) Placebo
(Na=20118)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
Female 35 2.926 (9573) 444 2.885 (9807) 92.2 (89.0, 94.7)
Race
White 67 5.076 (16321) 730 4.902 (16432) 91.1 (88.6, 93.2)
Black or African American 4 0.537 (1697) 48 0.519 (1690) 92.0 (78.0, 97.9)
American Indian or Alaska Native 0 0.040 (183) 3 0.037 (175) 100.0 (-120.7, 100.0)
Asian 3 0.251 (883) 23 0.239 (869) 87.6 (58.9, 97.6)
Native Hawaiian or other Pacific Islander 0 0.015 (51) 1 0.008 (30) 100.0 (-2017.6, 100.0)
Multiracial 3 0.148 (497) 22 0.124 (447) 88.6 (62.1, 97.8)
Not reported 0 0.025 (79) 6 0.029 (98) 100.0 (3.8, 100.0)
All othersf 6 0.480 (1693) 55 0.436 (1619) 90.1 (77.0, 96.5)
Ethnicity
Hispanic/Latino 29 1.768 (5052) 236 1.696 (5015) 88.2 (82.6, 92.3)
Non-Hispanic/non -Latino 47 4.293 (14559) 597 4.128 (14620) 92.4 (89.8, 94.5)
Not reported 1 0.031 (100) 0 0.033 (106) -∞ (NA, NA)
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)
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651635
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=19993) Placebo
(Na=20118)
Efficacy Endpoint
Subgroup n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
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)
USA 50 4.519 (15045) 630 4.350 (15122) 92.4 (89.8, 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.
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 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 fro m 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. All oth ers = American Indian or Alaska native, Asian, Native Hawaiian or other Pacific Islander, multiracial, and not reported race categories.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adc19ef Table Generation: 06AUG2021 (08:52)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA_Efficacy_v2/adc19ef_ve_cov_7pd2_wo_sg_e val
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651636
Vaccine Efficacy – First Severe COVID -19 Occurrence Based on CDC -Definition From 7 Days After Dose 2
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=21047) Placebo
(Na=21210)
Efficacy Endpoint n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe)
First severe COVID -19 occurrence based on CDC -definition from 7 days after
Dose 2 0 6.345 (20513) 31 6.225 (20593) 100.0 (87.6, 100.0)
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 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.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:19) Source Data: adc19ef Table Generation: 06AUG2021 (09:21)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblind ed/C4591001_BLA_Efficacy_v2/adc19ef_ve_sev_7pd2_cdc_eval
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651637
Vaccine Efficacy – First Severe COVID -19 Occurrence From 7 Days After Dose 2
– Blinded Placebo -Controlled Follow- up Period
– Subjects ≥ 16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2
– Evaluable Efficacy (7 Days) Populatio n
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=21047) Placebo
(Na=21210)
Efficacy Endpoint n1b Surveillance
Timec (n2d) n1b Surveillance
Timec (n2d) VE (%) (95% CIe) Pr (VE >30% | data)f
First severe COVID -19 occurrence from 7 days after
Dose 2 1 6.353 (20540) 21 6.237 (20629) 95.3 (70.9, 99.9) >0.9999
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 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. Posterior probability (Pr) was calculated using a beta -binomial model with prior beta (0.700102, 1) adjusted for surveillance time. Refer to the statistical
analysis plan, Appendix 2 , for more details.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:19) Source Data: adc19ef Table Generation: 06AUG2021 (09:07)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA_Efficacy_v2/adc19ef_ve_sev_cov_ 7pd2_eval
090177e197c4549e\Final\Final On: 09-Aug-2021 22:13 (GMT)
FDA-CBER-2021-5683-0651638