Document text
From: Naik, Ramachandra
Sent: Tuesday, July 13, 2021 5:11 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 – CBER comments regarding exception or alternative to the
requirement that products in multiple -dose vials include a preservative
Dear Ms. Harkins,
Our review of the information provided in your BLA STN 125742/0 for COMIRNATY (COVID -19 mRNA
Vaccine), for active immunization to prevent COVID -19 caused by SARS -CoV-2 in individuals 16 years of
age and older, is ongoing. COMIRNATY is supplied in a multiple -dose vial that does not contain a
preservative. Please note that 21 CFR 610.15(a) requires that “Products in multiple -dose containers
shall contain a preservative,…” The regulations in 610.15(d) per mit the approval of an exception or
alternative to this requirement. Requests for such exceptions or alternatives must be in writing. Your
submission does not include a request for an exception or alternative to the requirement of a
preservative. Theref ore, please submit a request and a justification for an exception or alternative to
the requirement under 21 CFR 610.15(a) that products in multiple -dose vials include a preservative.
Please provide your response in an Amendment to STN 125742/0, as soon a s possible.
Please confirm receipt of this email and let me know if you have any questions or need additional information.
Best 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-2021-5683-1024690