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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
20July2021
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
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OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
SN0413
Re:Covid-19 Vaccine(BNT162/PF -07302048)BB-IND 19736
IND Amendment –Protocol Amendment for StudyC4591001
Dear Dr. Gruber ,
Reference is made to BB- IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and B ioNTech are developing for the indication of active immun ization to
prevent coronavirus disease 2019 (COVID -19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS -CoV-2). The IND was effective on 29 April 2020.
Reference is also made to Study C4591001 protocolentitled, “A Phase 1/2/3, Placebo-
Controlled, Randomized, Obse rver-Blind, Dose -Finding S tudy to Describe the Safety,
Tolerability, Im munogenicity, and Effic acyof SARS-CoV-2 RNA Vac cine Candidates Against
COVID-19 in Healthy Individuals”and the current C4591001 Clinical Protocol incorporating
Amendme nt 16submitted to the INDon 02 June 2021 ( SN 0353).
The present submission provides C4591001 Clinical Protocol Amendme nt 17in Module
5.3.5.1, Clean cop yandTracked change copy.
ProtocolAmendme nt 17includesthe following key changes:
Changed the analysis methodfor the within- group comparison of seroresponse rates
for Phase 3 booster and VOC immunogenicit y assessment from the Miettinen and
Nurminen method to the adjusted Wal d interval toprovide tighter CI and higher
power for NI in most cases .
Clarified that any nonstudy coronavirus vaccines are to be recorded at any time they
are given during stud y participation .
FDA-CBER-2021-5683-1072526
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 20July2021
Pfizer Con fidential
Page 2Clarified that participants who are randomized in the C4591031 study should be
withdrawn from this study .
This submission has been scanned for viruses using McAfee VirusS can Enterprise Version
8.8 and is virus free . The subm ission is being sent via the Gate way.
Shouldyou have any questions regardingthis submission, or requi re additionalinformation,
pleasecontact me via phone a t 212-733-2613; via facsimileat 845-474-3500; or via e-mail at
neda.aghajanimemar@pfi zer.com.
Sincerely,
Neda Aghajani Memar, Pharm.D .
Director
Pfizer Global Regulatory A ffairs
CC: Ramac handra S. Naik, Ph.D .
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smit h, Ph.D.
FDA-CBER-2021-5683-1072527