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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
07 May 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics 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 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.
SN0324
Re: Covid-19 Vaccine (BNT162/PF -07302 048) BB-IND 19736
IND Amendment –Statistical Analysis Plan for Study C4591020
Dear Dr. Gruber ,
Reference is made to BB-IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioN Tech are developing for the pre vention of COVID -19 in adu lts ≥16
years of age .The IND was effective on April 29, 2020.
Reference is also made to study C45910 20protocol entitled , “A Phase 3, Randomized,
Observer -Blind Study to Evaluate the Safety, Tolerability, and I mmuno genicity of a
Lyophilized Formulation o f theVaccine Candidate BNT162b2 Against COVID -19 in Healthy
Adult s 18 Through 55 Years of A ge” submitted to the IND on 18 February 2021 [SN 0 221;
(Module 5.3.5.1)].
Enclos ed in this submission is the revised Statistical Anal ysis Plan version 2 forStudy
C45910 20provided in Module 5.3.5.1, Clean Copy and Track Ch anges .
This submission has been scanned for vir uses us ing McAfee VirusS can Ente rprise Version
8.8 and is virus free . The submission is be ing sent via the Gateway .
Should you have an y questio nsregarding t his submi ssion, or requi readditional information,
pleasecontact me via phone a t 212-733-2613 ; via fac simile at 845 -474-3500; or via e -mail at
neda.aghaj animemar@pfi zer.com .
FDA-CBER-2021-5683-1072499
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 07 May 2021
Pfizer Confid ential
Page 2Sincerel y,
Neda Aghajani Memar, Pharm.D.
Director
Pfizer Global Re gulatory Affairs
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1072500