Document text
From: Gottschalk, Laura
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
Thank you,
Laura
Laura B.
Gottschalk -SDigitally signed by Laura B. Gottschalk -S Date: 2022.07.05 11:08:02 -04'00'
FDA-CBER-2022-5812-0500495
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-2022-5812-0500496