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PFIZER CONFI DENTIAL
Page 1 Pfizer Inc
500 Arcola Road
Collegeville, PA 19426
Global Product Development
25August2020
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biologics 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, I N
WHOLE OR IN PART, FOR ANY OTHER
PURPOSE WITHOUT THE PRIOR WRITTEN
CONSENT OF PFIZER INC.
SN0068
Re:COVID-19 Vaccine(BNT162; PF-07302048) BB- IND 19736
Response to FDA 29 July2020 Information Request -Clinical Assay Qualificatio n
Dear Dr. Gruber,
Reference is made to BB- IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioNTech are developing for the prevention of COVID -19 in adults ≥
18 years of age . The IND was effective on 29 April2020.
Further reference is made to t he Qualification Information (assay method/manual and
qualification report) for the L uminex Assay for Quantitation of IgG Antibodies and the
SARS-CoV-2 mNeonGreen Virus Microneutralization Assay submitted to BB -IND 19736 on
10 July 2020 (SN 0030).
The present submission pro videsresponse to CBER’s information request received via email
on 29 July 2020 regarding clinical assay qualificatio n [Module 1.11.3 (Response to FDA
Request for Information )].
This submission has been scanned for vir usesusing McAfee VirusScan Enterprise Version
8.8 and is virus free. The submission is bei ngsent via the Gateway .
Should you have any questions regarding this submission , or require additional information,
please contact me via p hone at 215 -280-5503; via fa csimile at 845-474- 3500; or via e -mail at
FDA-CBER-2021-5683-1072453
BB-IND 19736 25Aug2020
Page 2 of 2
[email protected] .
Sincerely,
Elisa Harkins
Global Regulato ry Lead
GlobalRegulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-1072454