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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
23August 2021
Marion Gruber, Ph.D.
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 SECRET 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
COMIRNATY ( COVID -19 mRNA Vacci ne)
Final Label ing Change –BLA Package Insert for COMIRNATY
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA ) forCOMIRNATY ( COVID -
19 mRNA Vaccine ) developed by BioNTec h and Pfize r for the prevention of COVID -19
caused b y SA RS-CoV -2in individuals ≥16 y ears of age issued on 23 August 2021.
The present submission provides the final clean copy (PDF and Word ) of the package insert
for COMI RNATY associated with the receipt of the full FDA approval on 23 August 2021,
in Module 1.14.2.
Thefinal
Structured Product Labeling (SPL) will be pr ovided in the near future .
This submission has been scanned for viruses using McAfee VirusScan Enterprise Version
8.8 and is virus free.
Should you have any questions regarding this submission , or require additional information,
please contac
t me via phone at 214-918-5262 o r via e-mail at [email protected].
Sincerel y,
FDA-CBER-2021-5683-1007512
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 23August 2021
Pfizer Confid ential
Page 2Amit Patel
Director
Global Regulatory Affa irs -Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-1007513