Document text
Pfizer Global Regulatory Affairs
Pfizer Inc.
4300 Oak Park Road /Sanford, NC27330
Global Product Developm ent
28January2022
Peter Marks , M.D.Ph.D.
Acting Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS
CONFIDENTIAL AND/OR TRADE S ECRET
INFORMATION THAT IS DISCLOSED ONLY
IN CONNECTION WITH THE LICENSING
AND/OR REGISTRATION OF PRODUCTS FOR
PFIZER INC OR ITS AFFILIATED
COMPANIES. THIS DOCUMENT SHOULD
NOT BE DISCLOSED OR USED, IN WHOLE OR
IN PART, FOR ANY OTHER PURPOSE
WITHOUT THE PRIOR WRITTEN CONSENT
OF PFIZER INC.
Re:BLA 125742/45
COMIRNATY (COVID -19 mRNA Vaccine)
Subject: Response to 25January 2022 Information Request to Provide a Revised
356h and Environmental Assessment or Claim of Categorical Ex clusion
Dear Dr. Marks,
Reference is made to the Biologics License Application (BLA) 125742 for COMIRNATY
(COVID- 19 mRNA Vaccine ), developed b yBioNTech and Pfizer for the prevention of
COVID-19 caused b ySARS-CoV-2 in individuals ≥16 years of age issued on 23 August
2021.
Reference is also made to the 16 December 2021 Supplemental BiologicsLicense
Application to expand the indication of COM IRNATY to include adolescents 12 to 15 y ears
of age and to the 25 January 2022 Information Request requesting a revised FDA form 356h
that includes information regarding allestablishments and manufacturing facilities, and a n
Environmental Assessment or Claim of Categorical Exclusion . This submission includes a
revised 356h withthe requested information. In addition, a Module 1, 1.12.14 Request for
Categorical exclusion is provided.
This submission has been scanned for viruses using McAfee VirusScan Enterprise Version
8.8 and is virus free. The submission is being sent via the Gateway .
Should you have any questions regarding this submission, or require additional information,
please contact me via phone at or via e-mail at [email protected] .
(b) (6)
FDA-CBER-2022-5812-0073138
Peter Marks , M.D., Ph.D., Acting Director Page 2of 2
BLA 125742/ 45 28January 2022
Pfizer Confidential
Page 2Sincerely,
Adrienne Stafford
Director
Global Chemistry Manufacturing and Controls- Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
CC: Sarah Lee, MPH
CC: Iryna Zubkova, Ph.D.
FDA-CBER-2022-5812-0073139