Document text
From: Naik, Ramachandra <[email protected]>
Sent: Friday, August 20, 2021 2:23 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Rohlfing, Paul <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Boyce, Donna <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Gottschalk, Laura <[email protected]>
Subject: STN 125742/0 – COMIRNATY – CBER comments regarding label for identification of BLA lots and
Dear HCP Letter
Dear Ms. Harkins,
Our review of the information provided in your BLA STN 125742 for COMIRNATY (COVID -19 mRNA
Vaccine), for active immunization to prevent C OVID -19 caused by SARS -CoV-2 in individuals 16 years of
age and older, is ongoing. Please see the attached for CBER’s comments and revisions regarding the
information included in amendment 64 (dated August 19, 2021) about the label to include with the
vaccine tray package and the draft Dear HCP Letter.
Please refer to our August 20, 2021, 2:08 PM email communication regarding lots that you consider to be BLA -compliant, and confirm that EUA -labeled “lots in the field” will not be listed at cvdvaccine -
us.co m/resources until they are released by CBER.
Please provide your response in an Amendment to STN 125742/0, as soon as possible.
Please confirm receipt of this message 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-2021-5683-1024835