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Pfizer Global Regulatory Affairs
Pfizer Inc.
235East 42ndStreet/New York, NY 10017 -5755
Global Product Developm ent
18February 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 S ECRET
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.
SN0221
Re:Covid-19Vaccine(BNT162/ PF-
07302048) BB-IND 19736
CMC Amendment –Briefing Package Type C Written Response Only
IND Amendment –
Clinical: New Protocol for Study C4591020
Informed Consent Document for Study C4591020
Dear Dr. Gruber ,
Reference is made to BB -IND 19736 for BioNTech ’s COVID- 19 Vaccine (BNT162;
PF-07302048) for the prevention of COVID -19 in adults ≥16years of age . The IND was
effective on April 29, 2020.
Reference is also made to the Type C Meeting request submitted on 08 February 2021
(SN0206) to discuss new read y-to-use (RTU) and ly ophilized formulations of COVID -19
vaccine BNT162b2 / PF -07302048.
Please find enclosed the meeting background materials, con sisting of the Briefing Document
(Module 1.6.2) to support CBER’s feedback to BioNTech/Pfizer Written Response Onl y
(WRO).
Pfizer and BioNTech respectfully request feedback on the new RTU and l yophilized
formulations by 5March 2021.
This submission also provides the followi ngin Module 5.3.5.1:
FDA-CBER-2021-5683-1072488
Marion Gruber, Ph.D., Director Page 2of 2
BB-IND 19736 18February 2021
Pfizer Confidential
Page 2Study C4591020 protocol entitled, “ A Phase 3, Randomized, Observer -Blind Study to
Evaluate the Safety, Tolerability, and Immunogenicity of a Lyophilized Formulation
of the Vaccine Candidate BNT162b2 Against COVID-19 in Healthy Adults 18
Through 55 Years of Age ”
The Informed Consent Documentfor Study C4591020
This submission has been scanned for viruses using McAfee VirusScan Enterprise Version
8.8 and is virus free. The submission is being sent via the Gate way.
Should you have any questions regarding this submission, or require additional information,
please contact me via phone at 212 -733-2613; via facsimile at 845-474- 3500; or via e -mail at
[email protected].
Sincerely,
Neda Aghajani Memar, Pharm.D.
Director
Pfizer Global Regulatory Affairs
CC: Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-1072489