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LABELING REVIEW MEMORANDUM
To: The File
Date: August 2, 2022
STN: 125742/45
Supplement Type: Efficacy
Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.)
Product: COVID-19 Vaccine, mRNA (COMIRNATY)
From: Laura Gottschalk, Ph.D. and CAPT Mike Smith, Ph.D.
OVRR/DVRPA/RRB3
Through: Elizabeth M. Sutkowski, Ph.D.
OVRR/DVRPA/RRB3
Summary:
COMIRNATY was originally approved on August 23, 2021 (STN 125742/0)
for active immunization to prevent cor onavirus disease 2019 (COVID-19) caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years
of age and older. In the current applicati on, BioNTech has submitted an Efficacy
Supplement to the Biologics License Application (sBLA) to include use in adolescents 12 through 15 years of age. The product labeling submitted to the sBLA included new Package Inserts (PIs) for the
Tris/Sucrose formulation and the PBS/Sucrose formulation. Revisions to the proposed labe ling for the PIs were communicated to BioNTech as
indicated below in Table 1, and the corresponding amendments that were received are described in Table 2. BioNTech’s responses to CBER’s suggested revisions were submitted in Amendments 8 and 12. The fi nal draft labels were submitted in
Amendment 13 dated July 1, 2022. The principal reviewers of the labels were those in
the Clinical Review Team, Advertising and Promotional Labeling Branch, the OVRR
Immediate Office of the Director, and the Regulatory Project Managers.
Table 1. Labeling Review History
Date Action
04/08/2022 Internal labelin g meetin g.
04/20/2022 Internal labelin g meetin g.
04/20/2022 First set of labelin g comments on the PIs were sent to the applicant. Michael J.
Smith -S4Digitally signed by Michael
J. Smith -S4
Date: 2022.08.02 12:59:27 -04'00'
Elizabeth M. Sutkowski -SDigitally signed by Elizabeth M. Sutkowski -S Date: 2022.08.02 13:47:31 -04'00'
FDA-CBER-2022-5812-0500505
STN 125742/45 Labeling Review Memo
2 05/10/2022 Second set of labelin g comments on the PIs were sent to the applicant.
06/29/2022 Third set of labeling comments on the PIs were sent to the applicant. The
only change requested was to replace “M/YYYY” with “7/2022” for the
date under "recent ma jor chan ges" and "revision date."
7/05/2022 BioNTech was notif ied that the PI s submitted in Am endment 13, dated
07/01/2022, are considered the Final Draft Labels.
Table 2. Labeling Amendments
Date Amendment Summary
04/29/2022 STN 125742/45.8 Response to the first set of comments on the PI
dated 04/20/2022.
05/13/2022 STN 125742/45.12 Response to the second set of comments on the
PIs dated 05/10/2022.
07/01/2022 STN 125742/45.13 Response to t he third set of comments on the PIs
dated 06/29/2022. Final Draft Labels.
Regarding BioNTech’s Amendments containing revisions to the PI:
BioNTech submitted to CBER two versions of the PIs (as amendment s to the sBLA) in
response to CBER’s comments. BioNTech’s responses to CBER’s suggested revisions
regarding the PIs were submitted in Amendments 125742/45.8, 125742/45.12 and
125742/45.13. The clean copies of the PIs subm itted on July 1, 2022 (Amendment 13)
were considered the Final Draft PIs for approval. BioNTech was notified on July 5, 2022, that CBER considered the PIs included in Amendment 13 as the Final Draft PIs
for approval.
Review of National Drug Codes:
A review of the National Drug Codes was not done for this supplement since the product
presentations and how supplied are the same as those approved in the original BLA STN
125614/0 and Post Approval Supplement STN 125742/36.
Recommendation: The discipline reviewers mentioned above ha ve reviewed the relevant labeling
documents and found the PIs received in Amendment 13 dated July 1, 2022 to be acceptable as Final Draft Labeling for approval . As the Regulatory Project Manager, I
concur with their recommendation. The Final Draft PIs were provided to the Office of
Communication, Outreach and Development as part of the approval package for web
posting.
FDA-CBER-2022-5812-0500506