Document text
Pfizer Inc.
500 Arcola Road
Collegeville, PA 1426
Global Product Developm ent
04December2020
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.
SN0156
Re:Covid-19 Vaccine(BNT162/PF -07302048) BB-IND 19736
IND Amendment –New Protocol
Dear Dr. Gruber ,
Reference is made to BB-IND 19736 for the COVID -9 vaccine (BNT162; PF -07302048),
which Pfizer and BioN Tech are developing for the prevention of COVID -19 in adults ≥
16years of age. The IND was effective on April 29, 2020.
Further reference is made to Pfizer’s Clinical Information Amendment which included the
validation packages for the two diagnostic assay s (Cepheid Xpert Xpress RT- PCR test for the
detection of SAR S-CoV-2 in nasal swabs and Roche Elecs ys Anti-SARS-CoV-2 assay for
the evaluation of serostatus to SARS -CoV-2)submitted on 31 July 2020 (SN00 49).
Subsequently , on 8 August 2020 CBER confirm ed via email (communication from FDA
Project Manager Ramachandra Naik to Pfizer’s Elisa Harkins) that theyconcur with the use
of these assay s in study C4591001 but would be requesting additional information and
clarification on the interpretation of assay results.
The present submission provides VR-MVP-10074-Validation Protocol for the SARS -CoV-2
mNeonGreen Virus Microneutralization Assay .
This submission has been scanned for vir uses using McAfee VirusS can Enterprise Version
8.8 and is virus free . The submission is be ing sent via the Gateway .
FDA-CBER-2021-5683-1072478
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 December 04 , 2020
Pfizer Confid ential
Page2Should you have any questions regarding t his submission, or requi readditional information,
please contact me via phone at 215-280-5503; via facsimile at 845-474 -3500; or via e-mail at
elisa.harkinstul [email protected] .
Sincerely,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-1072479