Document text
August 17, 2021
Please Note,
The lots below are associated with this Supplement.
The lot(s) associated with this BLA/supplement will be released
upon completion of protocol review, any requested sample testing
and approval of the BLA/supplement.
Since lots are associated with this BLA/supplement please be sure to provide a copy of the signed approval to the Product
Release Branch by fax to 301.594.6924 or e- mail the letter to
CBER Lot Clearance.
STN Supp. # License
Number Company Product Lot
Type Lot Number Sample
Received Date
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FD7220 17 Aug 2021
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FE3592 17 Aug 2021
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FF2587 17 Aug 2021
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FF258 8 17 Aug 2021
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FF25 90 17 Aug 2021
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FF25 93 17 Aug 2021
125742 0 2229 BioNTech
Manufacturing GmbH COVID -19 FC FF8841 17 Aug 2021
FDA-CBER-2021-5683-0652260
Biologist, Product Release Branch
CBER/OCBQ/DMPQ
WO, Building 7 1, Room G 6062
240-402-9165 (main)/ 240 -402-5839 (office)/301- 595-1253 (fax)
Lot Release Information
From: Gottschalk, Laura <[email protected]>
Sent: Tuesday, August 17, 2021 10:49 AM
To: CBER Lot Clearance <[email protected]>; Beshir, Leyla <[email protected]>
Cc: Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra
<[email protected]>; Eichelberger, Maryna <[email protected]>;
Quander III, Joseph <[email protected]>; Hulme, Cheryl <[email protected]>
Subject: OVRR: Lot Clearance Request for STN 125742/0 - Please Respond by COB Thursday
Importance: High
Dear L ot Clearance,
Please confirm that there are no lots associated with this Submission. Please note, although the official actio
n due date is January 16, 2022, we are aiming to approve within the week. Therefore, please
provide a response by COB Thursday, Au g 19.
The lots are supposed to be received today. I have cc’ed some of the DBSQC team here in case they would like to provide any clarification or answer any questions that you may have.
• Applicant Name: BioNTech Manufacture GmbH (in partnership with Pfizer, Inc.)
• License Number: 2229
• Company Address: An der Goldgrube 12
Mainz, Germany 55131
• Application STN: 125742/0
• Product Name: COVID -19 Vaccine, mRNA (COMIRNATY)
• Submission Type: Original Application (Priority 8 Month)
• Action Due Date: January 16, 2022 (please see note above)
• Short Summary: For active immunization to prevent COVID -19 disease caused by
SARS- CoV-2 in individuals 16 years of age and older.
Thanks in advance and please let us know if you have any questions.
Best,
Laura
FDA-CBER-2021-5683-0652261
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
FDA-CBER-2021-5683-0652262