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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
20August2021
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
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
Change in Sponsor Authorized Re presentative for BLA 125742 (and Revised
1.4.3List of Authorized Persons)
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 2021 for
the COVID-19 mRNA Vaccine (BN T162/PF-07302048) developed by BioNTec h and Pfizer
under BB-IND19736 f or the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
I am writing to inform youof a change in the Sponsor Authorized Representative for BLA
125742. Effe ctive 23August 2021, Neda Aghajani Memar , Pharm.D. will be replaced b y
Amit Patel , Director, Global Regulatory Affairs – Vaccines. Amit Patel’s contact information
is provided below.
Amit Patel
Director, Global Regulatory Affairs – Vaccines
Pfizer, Inc.
235 East 42ndStreet
New York, NY 10017
Mobile Phone: 214-918-5262
Email: [email protected]
FDA-CBER-2021-5683-0950391
Marion Gru ber, Ph.D., Director Page2of 2
BLA125742 20August2021
Pfizer Confid ential
Page 2The revised 1.4.3 List of Authorized Persons is provided in this submission.
Should you have any questions regarding this subm ission, or requireadditionalinformation,
pleasecontact meviaphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark instull@pfizer. com.
Sincerely,
ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs –Vaccines
CC: Ramachandra S. Naik, Ph.D.
Captain Micha el Smith, Ph.D.
Laura Gottshalk, Ph.D.
FDA-CBER-2021-5683-0950392