Document text
From: Gottschalk, Laura
Sent: Thursday, July 29, 2021 6:22 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>
Subject: STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mR NA) – Comment regarding analyses for
safety for the two age groups
Dear Ms. Harkins:
Our review of the information provided in your BLA STN 125742/0 for COMIRNATY (COVID -19
Vaccine, mRNA), for active immunization to prevent COVID -19 caused by SARS -CoV-2 in
individuals 16 years of age and older, is ongoing. We have the following request for additional
information:
Please submit the analyses as presented in Table 7 (page 116) of the Summary of Clinical
Safety for the following age groups: 1) 16 through 55 years, 2) 56 years and older.
Please provide your response in an Amendment to STN 125742/0 by COB August 2, 2021. If
you have any questions about this communication, please feel free to contact me.
Best regards,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
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FDA-CBER-2021-5683-1024722