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From: Smith, Michael (CBER)
Sent: Friday, August 13, 2021 6:49 PM
To: Aghajani Memar, Neda <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>
Subject: STN 125742.0: One clinical question
Neda,
The clinical team has one question for Pfizer - see below. They requested a
response as soon as possible and no later than COB Monday, August 16, 2021.
1. Please complete the following table to describe the updated VE at later time
points periods, to supplement Table O provided with the VE shell tables in STN
125742.0.32.
Table O. Updated Vaccine Efficacy after Dose 1, Dose 1 All -Available Efficacy
Population
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
(68.0, 98.1)
≥7 Days after Dose 2 82
6.479 (21019) 870
6.207 (20901) 91
(88.7, 92.9)
≥7 Days after Dose 2 to <2 Months
after Dose 2
FDA-CBER-2021-5683-1024788
Efficacy Endpoint Subgroup BNT162b2
(Na=21909)
Cases
n1b
Surveillance
Timec
(n2d) Placebo
(Na=21908)
Cases
n1b
Surveillance
Timec
(n2d) Vaccine
Efficacy %
(95% CI)e
≥2 Months after Dose 2 to 4
Months after Dose 2
≥4 Months after Dose 2
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.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications Tel: 301- 796-2640
[email protected]
FDA-CBER-2021-5683-1024789
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FDA-CBER-2021-5683-1024790