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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
17September 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 SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AN D/OR
REG ISTRATION 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 125742/11
COMIRNATY (COVID -19 mRNA Vaccine)
General Correspondence – Correction to Previously Su bmitted Documents
Dear Dr. Gruber ,
Reference is made to the Biologics License Application (BLA) 125742 for COMI RNATY
(COVID -19 mRNA Vaccine ), developed by BioNTech and Pfizer for the preven tion of
COVID -19 cau sed b ySARS- CoV -2in individuals ≥16 years of age issued on 23 August
2021.
Reference is also ma deto the Response to FDA 17 August 2021 Information Request
Regarding Drug Substance and Drug Product
at K alamazoo and Puurs submitted formally on 19August 2021.
The purpose of this submission is to correct drug substance documents s ubmitted as a part of
this response. Three draft drug subst ance documents were inadvertentl y linked to t his
response. This correspondence re verts these draft documents back to the previously approved
documents. In support of this correspondence , the following documents are now reverted to
the indicated sequence :
Module 3, 3.2.S.2.2 , Description of Manufactu ring Process and Process Controls
[Andover ], sequence 0019
Module 3, 3.2.S.2.4, Control of Critical Steps and Intermedia tes,sequence 0 002
Module 3, 3.2.S.2.6, Manufacturing Process Development – Process Development and
Char acterization , sequence 0002
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149934
Marion Gruber, Ph.D. , Director Page 2of 2
BLA 125742 17 September 2021
Pfizer Confid ential
Page 2Thissubmission has been scanned for vir uses us ingMcAfee VirusS can Ente rprise Version
8.8 and is virus fr ee. The submission is be ing s ent via t he G ateway .
Should you have an y questions regarding t his submi ssion, or requi re additional informa tion,
pleasecontact me via phone a t 214-918-5262or via e-mail [email protected] .
Sincere ly,
Amit Patel
Director
Global Reg ulatory Affairs -Vaccines
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Gott schalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-1149935