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From: Naik, Ramachandra <[email protected]>
Sent: Wednesday, August 18, 2021 6:58 PM
To: Boyce, Donna <[email protected]>
Cc: Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura
<[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Ro hlfing,
Paul <[email protected]>
Subject: BLA STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) – Identification of BLA -compliant
lots and Letter to HCP
Dear Donna,
Reference is made your August 16, 2021 email communication and telephone conversat ion with Mary
Malarkey, Director, OCBQ/FDA, in which you shared a graphic for identification of BLA -compliant lots
and draft Dear HCP Letter. Please submit these and any relevant documents as an amendment to the
BLA.
If these documents have already been submitted, please point us to the amendment/sequence number and when these were submitted.
Please confirm receipt of this email and let me know if you have any questions or need additional
information.
Regards,
Ram
Ramachandra S. Naik, Ph.D.
Biologist (R egulatory) / Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301- 796-2640
ramachandra.naik @fda.hhs.gov
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FDA-CBER-2021-5683-1024824