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Pfizer Global Regulatory Affairs
Pfizer Inc
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
17 August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biologics 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 PRI
OR WRITTEN CONSENT
OF PFIZER INC.
Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF -07302048)
CMC Amendment Regarding 9
-Month Shelf Life Extension for the Undiluted
Drug Product at -90 to -60°C
Dear Dr. Gruber,
Reference is made to the Biologics LicenseApplication (BLA) submitted 18 May 2021 for
the COVID- 19 mRNA Vaccine (BNT162/PF -07302048) developed b y BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
This amendment to BLA 125742 contains the same supporting data submitted to EUA 27034
Amendment 260 on 13 August 2021, to support a shelf- life extension of the undiluted drug
product of up to 9 -months when stored at the intended long term storage condition . Due to
the differences between the leaflet structure of the IND and the BLA, formatting of the
submissions is slightly different. A summary of changes is supporting these updates is
provided below:
Introduction of additional stability data to support e xtending the shelf -life of the
undiluted drug product vial from 6 months to 9 months when stored at -90 to -60°C.
Corrections made a ty pographical error in DSPC result for lot EJ0553 made in a
stability data tables that occurred in a previous submission.
Addition of inverted vial orientation data for various lots at the 5°Cand -20°C
long term and accelerated condition s.
FDA-CBER-2021-5683-1149638
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 17August2021
Pfizer Confidential
Page 2Addition of Figures illustrating stabilit y data for LNP poly dispersity, LNP size, RNA
content, RNA encapsulation, lipid content, RNA integrity, and in vitro expression.
A Module 2, 2.3 Introduction is included and contains a comprehensive list of new or revised
documents to provide CBER with a comprehensive CMC package for review.
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 contac
t me via phone at 215-280-5503; via facsimile at 845-474-3500; or via e-mail at
[email protected] .
Sincerely,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC:Captain Michael Smith, Ph.D.
CC:Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1149639