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From: Naik, Ramachandra <[email protected]>
Sent: Monday, August 16, 2021 5:26 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Rohlfing, Paul <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Boyce, Donna <[email protected]>
Subject: STN 125742/0 – COMIRNATY – Submission of CMC information to support extension of shelf life
of BNT162b2 to 9 months
Dear Ms. Harkins,
Reference is made to the amendment 260 to your EUA 27034 (dated August 13, 2021) that contains the
CMC information in support of extension of shelf -life of the undiluted drug product for up to 9
months. Please submit this same CMC stability information to your BLA STN 125742 so that we can
consider a 9 -month shelf -life for the licensed product. We are reviewing the data under EUA 27034, but
we want it formally submitted to the BLA.
Please submit this information to STN 125742/0 by COB Tuesday, August 17, 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-2021-5683-1150262