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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
24May2021
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
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Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF -07302048 )
Response to FDA 20May 2021 Information Request Regarding Manufacturing
Schedules for the Pfizer Andover, Puurs and Kalamazoo Manufacturing
Facilities and COVID -19 Precautions at Each Manufacturing Facility
Dear Dr. Gruber,
Reference is made to the Biologics License Application (BLA) submitted 18 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed b y BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
On 20 May 2021, the Agency provided an Information R equest regarding manufacturing
schedules for the Pfizer Andover, Puurs, and Kalamazoo manufacturin g facilities as well as
COVID-19 precautions taken at each manufacturing facility related to visitor entry
requirements. The requested information is provided in Response to 20 May 2021 FDA IR
in Module 1.11.1.
Additional requirements for travel to Belgium areprovided in:
Guidelines for Business Travel from a Red Zone to Belgium in Module 3.2.R
Requirements for Travel to Belgium in Module 3.2.R
FDA-CBER-2021-5683-1149295
Marion Gruber, Ph.D., Director Page 2of 2
BLA125742 24 May2021
Pfizer Confidential
Page 2In addition, the Agency requested a teleconference to discuss production schedules and
for the Puurs, Belgium site. Ateleconference has been scheduled
and confirmed for Tuesday , 25 May 2021 starting at 10:00 AM ET.
Should you have any questions regarding this submission, or require additional information,
please contact me via phone at 215 -280-5503; via facsimile at 845-474- 3500; or via e -mail at
[email protected] .
Sincerely,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
(b) (4)
FDA-CBER-2021-5683-1149296