Document text
From: Naik, Ramachandra <[email protected]>
Sent: Monday, July 19, 2021 11:40 AM
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]>; Rohlfing, Paul <[email protected]>
Subject: BLA STN 125742/0 – COMIRNATY - COVID -19 mRNA Vaccine - Issuance of BLA license number in
advance of approval
Dear Ms. Harkins,
Reference is made to your request in the cover letter to the first roll of your BLA for COMIRNATY dated
May 6, 2021, for the US Li cense Number for BioNTech Manufacturing GmbH with the agreement that it
will not be used until after the BLA is approved.
At this time, we are providing a US License Number of 2229 to facilitate product labelling in advance of
approval during the declared Public Health Emergency. Provision of this number does not constitute
any determination by FDA on the application.
Please confirm receipt of this email and let me know if you have any questions or need additional
information.
Regards,
Ram
Ramachandr a 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
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE
UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the
addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this
document in error, please immediately notify the sender by e -mail or phone.
FDA-CBER-2021-5683-1150187