Pfizer-BioNTech COVID-19 vaccine
The Pfizer-BioNTech COVID-19 vaccine is a series of mRNA-based gene therapy products marketed as vaccines against COVID-19. The term is used to describe multiple versions of the product developed by Pfizer and BioNTech. Its official brand name is Comirnaty.
While initially referring primarily to BNT162b2 (the original formulation authorized for mass distribution) the names "Pfizer-BioNTech COVID-19 vaccine" and "Corminaty" are increasingly used to refer to subsequent reformulated versions, including those for the XBB.1.5 variant of SARS-CoV-2.
History
On December 6, 2024, U.S. District Judge Mark Pittman ordered the Food and Drug Administration (FDA) to disclose its Emergency Use Authorization (EUA) file for the Pfizer-BioNTech COVID-19 vaccine product to Public Health and Medical Professionals for Transparency (PHMPT).[1]
On August 27, 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the FDA had rescinded the EUA for all available COVID-19 vaccines, including Comirnaty, while granting full market authorization for use in people over 65 years old or with at least one underlying condition.[2][3]
National contracts
Albania
Between Pfizer, the Albanian Ministry of Health and Social Protection and the Institute of Public Health in Albania.
- January 6, 2021: Manufacturing and Supply Agreement
Brazil
Between Pfizer and the Ministry of Health of Brazil.
- March 18, 2021: Purchase Agreement
Canada
Between Pfizer and the Minister of Public Works and Government Services Canada on behalf of Public Services and Procurement Canada.
- October 26, 2020: Manufacturing and Supply Agreement
South Africa
Between Pfizer and the National Department of Health of South Africa.
- March 30, 2021: Manufacturing and Supply Agreement
- June 4, 2021: Amendment to Manufacturing and Supply Agreement
- Binding Term Sheet
Product monographs
Canada
- September 28, 2023: COMIRNATY® Omicron XBB.1.5
- October 25, 2024: COMIRNATY® Omicron KP.2
Studies
- December 11, 2020: "BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2"
- Preprint published on bioRxiv
- February 1, 2021: “BNT162b vaccines protect rhesus macaques from SARS-CoV-2”
- Published in Nature
- December 3, 2024: "BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence"
- Authored by Ulrike Kämmerer, Verena Schulz and Klaus Steger
- Published in Science, Public Health Policy and the Law
External links
Scarcella, M. (2024, December 6). FDA must disclose more COVID-19 vaccine records, US judge rules. Reuters. http://archive.today/2024.12.07-025642/https://www.reuters.com/legal/government/fda-must-disclose-more-covid-19-vaccine-records-us-judge-rules-2024-12-06/ ↩︎
Secretary Kennedy [@SecKennedy]. (2025, August 27). “I promised 4 things: 1. to end covid vaccine mandates. 2. to keep vaccines available to people who want them, especially the vulnerable. 3. to demand placebo-controlled trials from companies. 4. to end the emergency...” [Post]. X (Formerly Twitter). http://archive.today/2025.08.28-075438/https://x.com/SecKennedy/status/1960742897201872969 ↩︎
Alatovic, J., & Maffei, D. (2025, August 27). Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19. Pfizer. https://web.archive.org/web/20250902191118/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval ↩︎
Further reading
Warner Mendenhall