Document text
May 13, 2022
Please Note,
A review of PRB records indicates that there are no pending lots
or issues that would affect the approval of the stated STN.
125742/45
Biologist, Product Release Branch
CBER/OCBQ/DMPQWO, Building 71, Room 6062
240-402-9165 (main)/ 240-402-5839 (office)
[email protected]
Lot Release Information
_________________________________________________
From: Gottschalk, Laura <[email protected]>
Sent: Wednesday, May 11, 2022 7:52 PM
To:CBER Lot Clearance <cbe [email protected]>
Cc:Naik, Ramachandra <[email protected]>; MaguireThon, Meghan
<[email protected]>; Smith, Mi chael (CBER) <[email protected]>
Subject: OVRR: Lot Clearance Request for STN 125742/45
Leyla P. Beshir -SDigitally signed by Leyla P. Beshir
-S Date: 2022.05.13 11:21:53 -04'00'
FDA-CBER-2022-5812-0500483
Please confirm that there are no pending lot release issues that would prevent approval
of this 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: June 17, 2022, but we may take action by the end of May
x Summary: For active immunization to prevent coronavirus disease 2019 (COVID-19) caused
by severe acute respiratory syndrome coronaviru s 2 (SARS-CoV-2) in adolescents 12 through 15
years of age.
Thanks,
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-2022-5812-0500484