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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
26August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl 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 Vaccine)
Structured Product Labeling (SPL) –BLAPackage 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 Pfizerfor the prevention of COVID -19
causedby SARS-CoV-2in individuals ≥16 years of age issued on 23 August 2021.
Reference is also made to the 23 August 2021 and 24 August 2021 submissions of the final
BLA package Insert for COMI RNATY. The present submission provides the Structured
Product Labeling (Module 1.14.2) for the final BLA Package Insert for COMI RNATY.
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 contact me via phon
e at 214-918-5262 o r via e-mail at [email protected].
Sincerely,
Amit Patel
FDA-CBER-2021-5683-0951281
Marion Gru ber, Ph.D., Director Page2of 2
BLA125742 26August2021
Pfizer Confid ential
Page 2Director
Global Regulatory Affairs -Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smith, P h.D.
FDA-CBER-2021-5683-0951282