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From: Smith, Michael (CBER)
Sent: Monday, March 14, 2022 9:17 AM
To:Collins, Kathleen Mary Catherin e
Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Mineo, Gosia Harkins Tull, Elisa
<[email protected]>; Devlin , Carmel M <[email protected]>
Subject: STN 125742/45 – Comirnaty sBLA – F/U Clinical-statistical question to Pfizer's response to our
3/7 comments regarding updated immunobridging analyses and solicited adverse reaction frequencies
Kate,
The review team has a follow-up question to Pfizer’s response that was submitted in
STN 125742.45.4 in response to the review team’s 3/7/22 clinical and statistical questions.
You state that no additional reactogenicity data have been recorded in the e-diary since
the EUA. However, we note that the numbers of placebo subjects who reported any headache, chills, and diarrhea post Dose 2 ar e 263, 73, and 43, respectively in the
SDTM (1 Month Follow-up) datasets and the draft prescribing information, while the respective counts appear to be 264, 74, and 44 in the SDTM (6 Month Follow-up) datasets. Please clarify the discrepancy and provide updated reactogenicity tables as appropriate.
Regards,
Mike
- Please confirm receipt of this email and let us know if you have any questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug AdministrationCenter for Biologics Evaluation & ResearchOffice of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: [email protected]
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Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0 9.2342.19200300.100.1.1=0014080934, cn=Michael J. Smith -S4 Date: 2022.03.14 09:20:14 -04'00'
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FDA-CBER-2022-5812-0500353
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