Document text
From: CBER Complicheck <[email protected]>
Sent: Friday, July 1, 2022 11:42 AM
To: Gottschalk, Laura <[email protected] v>; CBER Complicheck <[email protected]>
Cc: Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra
<[email protected]>; MaguireThon, Meghan <[email protected]>
Subject: RE: OVRR: Expedited Compliance Check Request for STN 125742/45
x Applicant Name: BioNTech Manufacturing GmbH (in partnership with Pfizer,
Inc.)
x Product Names: COVID-19 Vaccine, mRNA (COMIRNATY)
x License Number: 2229
x Address: BioNTech Manufacturing GmbH, An der Goldgrube 12 Mainz,
GERMANY
x Application #: 125742/45
x Submission type: Efficacy supplement
x Action Due Date: Target ADD of next Friday, July 8, 2022 (Previously June 17,
2022)
x Summary: For active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents 12 through 15 years of age.
List of manufacturing locations affected by the changes identified in the supplement:
1. Pharmacia & Upjohn Company LLC (Pfizer)
7000 Portage Road Kalamazoo, MI 49001 FEI#: 1810189
2. Pfizer Manufacturing Belgium NV
Rijksweg 12 Puurs, Belgium 2870 FEI#: 1000654629
3. Hospira, Inc
1776 North Centennial Drive McPherson, Kansas 67460 FEI# 1925262
There are no ongoing or pending investigations or compliance actions with respect to the above facility or its product(s). Therefore, the Office of Compliance and Biologics Quality, Division of Case
Management does not object to the approval of this supplement.
Daniel DeCiero
Consumer Safety Officer Laura B.
Gottschalk -SDigitally signed by Laura B. Gottschalk -S Date: 2022.07.05 11:07:16 -04'00'
FDA-CBER-2022-5812-0500499
OCBQ/DCM/BDDCB
WO71, Room 5011B
240-402-1666
From: Gottschalk, Laura < [email protected] >
Sent: Monday, June 27, 2022 5:38 PM
To: CBER Complicheck < [email protected] >
Cc: Smith, Michael (CBER) < [email protected] >; Naik, Ramachandra
<[email protected] >; MaguireThon, Meghan < [email protected] >
Subject: OVRR: Expedited Compliance Check Request for STN 125742/45
Please execute a compliance check for the following efficacy supplement:
x Applicant Name: BioNTech Manufacturing GmbH (in partnership with Pfizer,
Inc.)
x Product Names: COVID-19 Vaccine, mRNA (COMIRNATY)
x License Number: 2229
x Address: BioNTech Manufacturing GmbH, An der Goldgrube 12 Mainz,
GERMANY
x Application #: 125742/45
x Submission type: Efficacy supplement
x Action Due Date: Target ADD of next Friday, July 8, 2022 (Previously June 17,
2022)
x Summary: For active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) in adolescents 12 through 15 years of age.
List of manufacturing locations affected by the changes identified in the supplement:
1. Pharmacia & Upjohn Company LLC (Pfizer)
7000 Portage Road Kalamazoo, MI 49001 FEI#: 1810189
2. Pfizer Manufacturing Belgium NV
Rijksweg 12 Puurs, Belgium 2870 FEI#: 1000654629
3. Hospira, Inc
1776 North Centennial Drive McPherson, Kansas 67460 FEI# 1925262
FDA-CBER-2022-5812-0500500
Thank you,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review U.S. Food and Drug Administration
Tel: 301-796-0798
laura.gottschalk@fda hhs.gov
FDA-CBER-2022-5812-0500501