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From: Smith, Michael (CBER)
Sent: Friday, August 13, 2021 10:31 AM
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: Three questions from the clinical te am
Neda,
The clinical team has three questions for Pfizer – see below. Please respond by
COB Monday, August 16, 2021.
1. Please complete the following table to describe follow -up time for the efficacy
population.
Table. Blinded Follow- up Time after Dos e 2, Phase 2/3 Participants 16 Years of
Age and Older, Evaluable Efficacy Population
Vaccine Group (as Randomized)
BNT162b2
Na=21047
nb (%) Placebo
Na=21210
nb (%) Total
Na=42257
nb (%)
Evaluable efficacy (7 days) population
<2 Months
≥2 Months to <4 Months
≥4 Months to <6 Months
≥6 Months
Note: HIV- positive participants are not included in this summary because they are
not included in the efficacy analyses.
a. N = number of participants in the analysis population for the primary efficacy
endpoints (evaluable participants with and without evidence of prior infection).
This va lue is the denominator for the percentage calculations
b. n = Number of subjects with the specified characteristic.
FDA-CBER-2021-5683-1024791
2. Please provide the number of participants, by age cohort, who received
placebo originally and opted not to receive BNT162b2 after unblinding.
3. Please provide a breakdown of the subjects by age cohorts (young adults and
older adults) who have ≥6 months of follow -up from Dose 2 to the earlier of
discontinuation or the cutoff date, separately for the Safety and Evaluable Efficacy Popula tions. Please also provide a breakdown of these subjects,
number of doses received and time of follow up after last dose.
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]
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FDA-CBER-2021-5683-1024792