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From: Naik, Ramachandra <[email protected]>
Sent: Wednesday, July 28, 2021 2:16 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected]>
Subject: STN 125742/0 - COMIRNATY (COVID -19 Vaccine, mR NA) - Preliminary comments on Package
Insert
Dear Ms. Harkins,
Inserted in the attached please find preliminary requested changes and comments on the draft Package
Insert for COMIRNATY. Please note that we have not reviewed Section 6 (Adverse reactions) or Section
14 (Clinical Studies). Comments on these sections will be provided after review. Please submit a revised
draft of the Package Insert to include the revisions requested by COB Monday, August 2, 2021.
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 (Regulatory) / 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-2021-5683-1024721