Document text
Transmittal Memo
TO: Lorrie McNeill
DirectorOffice of Communication, Outreach and Development
FROM: Marion F. Gruber, Ph.D.
DirectorOffice of Vaccines Research and Review
RE: Action Package for: STN 125742/0, COVID-19 Vaccine, mRNA (COMIRNATY)
DATE: August 23, 2021
Office Point of Contact: Laura Gottschalk, Ph.D.
Please include the following information for posting on Web pages:
Proper Name: COVID-19 Vaccine, mRNA
Tradename: COMIRNATYManufacturer: BioNTech Manufacturing GmbHIndication: COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Please review and redact the documents indicated 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 identified as “Post to Web” in CBER regulatory systems comprise the official
Action Package for Posting under Section 916 of FDAAA for original BLAs/NDAs.
Please add the following information to CBER’s Approval Web page:
Demographic Subgroup Information – COVID-19 Vaccine, mRNA (COMIRNATY)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the
clinical trials and any analysis of demographic subgroup outcomes that is notable.
In addition, please post appropriate documents on the Web pages indicated in the following
table.
Web pagePost?
(Add “X”
if Yes )
FDA’s PREA Web page
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-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-therapy-products/approved-cellular-and-gene-therapy-products )Marion F.
Gruber -SDigitally signed by Marion F. Gruber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300077111, cn=Marion F. Gruber -S Date: 2021.08.23 08:22:53 -04'00'
FDA-CBER-2021-5683-0652377
Web pagePost?
(Add “X”
if Yes )
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
(https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-
infectious-agents-and-hiv-diagnostic-assays ) [IF SELECTED, PROVIDE THE
APPLICABLE ASSAY TABLE AND DATA TO BE INCLUDED IN TABLE]
Infectious Disease Testing
(http://www.fda.gov/BiologicsBloodVaccines/Bl oodBloodProducts/ApprovedProducts/License
dProductsBLAs/BloodDonorScreenin g/InfectiousDisease/default.htm )
Testing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Donors
for Relevant Communicable Disease Agents and Diseases ( https://www.fda.gov/vaccines-
blood-biologics/safety-a vailability-biologics/te sting-human-cells-t issues-and-cellular-
and-tissue-based-product-hctp-donors-relevant-communicable )
FDA-CBER-2021-5683-0652378