Document text
Transmittal Memo
TO:
FROM: Lorrie McNeill
Director, OCOD
Doran Fink, M.D., Ph.D.
$FWLQJ Deputy Director
Office of Vaccines Research and Review
RE: Action Package for: STN 125742/45, COVI D-19 Vaccine, mRNA (COMIRNATY)
DATE: July 8, 2022
Office Point of Contact: Laura Gottschalk, Ph.D.
Please update the following information on CBER’s Approval Web page for the product
referenced above:
Proper Name: COVID-19 Vaccine, mRNA
Tradename: COMIRNATY
Manufacturer: BioNTech Manufacturing GmbH
Indication: For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by
severe acute respiratory syndrome coronavirus 2 (SAR S-CoV-2) in individual s 12 years of age and
older.
Please review and redact the documents indicat ed in the options below and post on CBER’s
Approval Web page. Additional WORD documents (including labeling) are provided via e-mail to
‘CBER-OCOD-Action Packages’ on the date of approval.
The documents provided via e-mail with this trans mittal memo comprise the official Action
Package for Posting for this supplement approval.
In addition, please post appropriate documents on the Web pages indicated in the following
table.
Web page Post?
(Add “X”
if Yes )
CBER’s Pediatric Labeling Web page
(https://www.fda.gov/about-fda/center-b iologics-evaluation-and-research-
cber/biolo gics-prea-reviews-and-labelin g-chan ges) X
Vaccines Licensed for Use in the United States ( https://www.fda.gov/vaccines-blood-
biolo gics/vaccines/vaccines-licensed-use-united-states ) X
Approved Cellular and Gene Therapy Products ( https://www.fda.gov/vaccines-blood-
biologics/cellular-gene-t herapy-products/approved-ce llular-and-gene-therapy-
products )
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic
Assays
(https://www.fda.gov/vaccines-blood-biologi cs/complete-list-donor-screening-assays-
infectious-a gents-and-hiv-dia gnostic-assa ys) Doran Fink -SDigitally signed by Doran Fink -S
Date: 2022.07.08 13:52:09 -04'00'
FDA-CBER-2022-5812-0500503
Web page Post?
(Add “X”
if Yes )
Infectious Disease Testing
(https://www.fda. gov/vaccines-blood-biolo gics/infectious-disease-tests )
Testing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Donors for Relevant Communica ble Disease Agents and Diseases
(https://www.fda.gov/vaccines-blood-biologics /safety-availability -biologics/testing-
human-cells-tissues-and-cellu lar-and-tissue-based-product-hctp-donors-relevant-
communicable )
Approved Risk Evaluation and Mitigation Strategies (REMS)
(https://www.accessdata.fda. gov/scripts/cder/rems/index.cfm )
FDA-CBER-2022-5812-0500504