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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Our STN: BL 125742/45 ACKNOWLEDGEMENT
PRIOR APPROVAL SUPPLEMENT
BioNTech Manufacturing GmbH
Attention: Amit Patel January , 2022
Pfizer Inc. 235 East 42nd Street New York, NY 10017
Dear Mr. Patel:Please refer to your supplement to your Bi ologics License Application (BLA) submitted
under section 351(a) of the Public Health Se rvice Act (PHS Act) for COVID-19 Vaccine,
mRNA (COMIRNATY).
Reason for the submission: For active immunization to prevent coronavirus disease
2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS
CoV2) in adolescents 12 through 15 years of age.
Date of Supplement : December 16, 2021
Date of Receipt: December 16, 2021
US License Number: 2229
Your submission is in the form of a “Prior Approval Supplement” (21 CFR 601.12(b))
that requires CBER approval prior to t he distribution of product made using the
changes.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), amended by Title VIII
of the Food and Drug Administration Amendme nts Act of 2007 (FDAAA) (Public Law
No. 110-85, 121 Stat. 904).All future correspondence regarding this subm ission 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-s ubmissions-electronic-and-paper or the Electronic
Submission Gateway at https://www.fda.gov/electr onic-submissions-gateway .
Please note that the Electroni c Submissions Gateway (ESG) is an Agency-wide solution
for accepting electronic regulatory submissi ons that enables the secure submission of
regulatory information for review. Instructions for setti ng up an ESG account can be
found at http://www.fda.gov/ForIndustry/Electr onicSubmissionsGateway/default.htm.
FDA-CBER-2022-5812-0500302
Page 2 – STN 125742/45 – Amit Patel
CBER strongly encourages the use of secure email. Secure email makes use of
encryption during transmission and the mess ages 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 .
This acknowledgment does not mean that this supplement has been approved, nor
does it represent any evaluation of the adequacy of the data submitted. Following a
review of this submission, we will advise you in writing as to what action has been taken
and request additional information if needed.
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 ResearchElizabeth M.
Sutkowski -SDigitally signed by Elizabeth M. Sutkowski -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300076199, cn=Elizabeth M. Sutkowski -S Date: 2022.01.05 11:16:43 -05'00'
FDA-CBER-2022-5812-0500303