Document text
From: Gottschalk, Laura
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, Michael (CBER) <[email protected]>
Subject: OVRR: Lot Clearance Request for STN 125742/45
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 coronavirus 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
Laura B.
Gottschalk -SDigitally signed by Laura B. Gottschalk -S Date: 2022.05.19 14:08:49 -04'00'
FDA-CBER-2022-5812-0500482