Document text
From:Gottschalk, Laura
Sent:Monday, September 20, 2021 3:05 PM
To:Patel, Amit <[email protected]>
Cc:Devlin, Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]>;
; [email protected]; Smith, Michael (CBER)
<[email protected]>; Naik, Ramachandra <[email protected]>
Subject:STN 125742/9 -COVID-19 Vaccine, mRNA (COMIRNATY): Product Correspondence -CBER
response to plan for reporting Biologic Product Deviation Reports
Dear Mr. Patel,
We refer you to your Product Correspondence submitted and received on September 15, 2021 to STN
125742/9 to request comments and advice for reporting of Biologic Product Deviation Reports to the
EUA as well as to the BLA. We agree with your plan for reporting of Biological Product Deviation Reports
to the BLA and including any affected EUA lots in those reports, as described in your STN 125742/9
submission.
Please acknowledge receipt of this communication and let me know if you have any questions.
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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(b) (6)
FDA-CBER-2021-5683-1072438