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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: COVID -19Vaccine (BNT162/ PF-07302048)BLA 125742/10
BLA Amendment –Change in Sponsor Authorized Representative s for BLA
125742 (and Revised 1.4.3 List of Authorized Person s)
Dear Dr. Gruber ,
Reference is made to the Biologics License Application (BLA) 125742 for COMI RNATY
(COVID -19 mRN A Vaccine), developed b y BioNTech and Pfizer for the prevention of
COVID -19 caused b y SARS -CoV -2 in individuals ≥16 y ears of age issued on 23 August
2021 .
I am writing to inform y ou of the addition of two Sponsor Authorized Representative sfor
BLA 12572 ,effective on 1 7September 2021. Adrienne Staff ord, Director, Global
Regulatory Affairs,CMC, Pfizer Vaccine sand Rich Pelt , Sr. Director, Global Regulatory
Affairs, CMC, Pfizer Vaccines are being added as sponsor authorized representatives . The
previously prov ided sponsor authorized representatives remain valid.
Adrienne Stafford
Director, GCMC Vaccines
Pfizer, I nc.
4300 Oak Park, Sanford, NC 27410
Email: Adrienne.stafford@pfi zer.com
Rich Pelt
Senior Director, GCMC Vaccines
Pfizer, I nc.
(b) (6)
FDA-CBER-2021-5683-1149930
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 /10 17September 2021
Pfizer Confid ential
Page 2The Revised List of Authorized Persons is also provided inthis submission in module 1.4.3 .
This submission has been s cann ed for vir uses us ing McAfee VirusS can Ente rprise Versi on
8.8and is vir us free. The submission i s being sent via the Gateway .
Should you have an y questions reg arding t his submi ssion, or require additional informa tion,
pleasecontact me via phone a t 214-918-5262or via e-mail at Amitkumar.Patel@pfizer. com.
Sincerel y,
Amit Patel
Director
Global Regulatory Affairs -Vaccines
CC: Ramac handraS. Naik, Ph.D.
CC: Laura Gottschalk, Ph .D.
CC: Captain Michael Smith, Ph.D.
(b) (6)
FDA-CBER-2021-5683-1149931