Document text
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 2099 3
www.fda.gov
Our STN: BL 125742 /0 ACKNOWLEDGEMENT
BioNTech Manufacturing GmbH
Attention: Elisa Harkins May 13 , 2021
500 Arcola Road
Collegeville , PA 19426
Dear Ms. Harkins :
Please refer to your B iologics License Application (BLA) submitted under section 351(a)
of the Public Health Service Act (PHS Act) for the following biological product:
Our Submission Tracking Number (STN) : BL 125742
Name of Biological Product : COVID -19 mRNA Vaccine
Indication: Active immunization to prevent COVID -19 caused by SARS -CoV-2 in
individuals 16 years of age and older .
Date of Application: May 6, 2021
Date of Receipt : May 6, 2021
We have received your application submitted under provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an
incomplete application for a Fast Track Product. We acknowledge your schedule for
submission of the remaining portions of this application. In accordance with this section
of the FDCA, our review clock will not start until the date on which you submit the final
portion and inform us that your application is complete.
Please note that you are also responsible for complying with the applicable provisions of sections 402(i) and (j) of the PHS Act (42 U.S.C. §§ 282(i) and (j) ), which was amended
by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110- 85, 121 Stat.904).
All future correspondence regarding this submission should be identified prominently with the number assigned and should be submitted to either the CBER Document
Control Center at https://www.fda.gov/about- fda/center -biologics -evaluation- and-
research- cber/regulatory -submissions -electronic -and-paper or the Electronic
Submission Gateway at https://www.fda.gov/electronic -submissions -gateway .
FDA-CBER-2021-5683-1150167
Page 2 – STN 125742 /0 – Elisa Harkins
Please note that the Electronic Submissions Gateway (ESG) is an Agency -wide solution
for accepting electronic regulatory submissions that enables the secure submission of
regulatory information for review. Instructions for setting up an ESG account can be
found at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm .
The Center for Biologics Evaluation and Research ( CBER) strongly encourages the use
of secure email. Secure email makes use of encryption during transmission and the
messages are decrypted upon receipt using the certificate. To establish secure email,
please follow the instructions in SOPP 8119 Use of Email for Regulatory
Communications, Appendix A available at http://www.fda.gov/
BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs
/ucm109645.htm .
If you have any questions, please contact the Regulatory Project Managers,
CAPT Mike Smith ,
Ph.D., [email protected] and
Laura Gottschalk , Ph.D., [email protected] or at (301) 796- 2640.
Sincerely,
Elizabeth M. Sutkowski, Ph.D.
Chief
Regulatory Review Branch 3
Division of Vaccines and
Related Products Applications Office of Vaccines
Research and Review Center for Biologics
Evaluation and Research
FDA-CBER-2021-5683-1150168