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# Pfizer-BioNTech COVID-19 vaccine
- URL: https://www.whiteroseintelligence.com/pfizer-biontech-covid-19-vaccine/
- Published: 2026-03-13T16:39:00.000Z
- Updated: 2026-03-13T16:40:10.000Z
- Author: Liam Sturgess
- Tags: Profiles, #docs, #pharmaproduct, COVID-19, Product, #toc
The **Pfizer-BioNTech COVID-19 vaccine** is a series of mRNA-based gene therapy products marketed as [vaccines against COVID-19](https://www.whiteroseintelligence.com/COVID-19-vaccine). The term is used to describe multiple versions of the product developed by [Pfizer](https://www.whiteroseintelligence.com/Pfizer) and [BioNTech](https://www.whiteroseintelligence.com/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](https://www.whiteroseintelligence.com/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](https://www.whiteroseintelligence.com/Public-Health-and-Medical-Professionals-for-Transparency) (PHMPT).[\[1\]](#fn1)
On August 27, 2025, Health and Human Services Secretary [Robert F. Kennedy Jr.](https://www.whiteroseintelligence.com/Robert-F-Kennedy-Jr) announced that the FDA had rescinded the EUA for all available COVID-19 vaccines, including Comirnaty, while granting full market authorization for use in people over 65 years old or with at least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.[\[2\]](#fn2)[\[3\]](#fn3)
## 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](https://web.archive.org/web/20231117184712/https://ti-health.org/wp-content/uploads/2021/05/Albania-Pfizer.pdf)
**Brazil**
Between Pfizer and the Ministry of Health of Brazil.
- March 18, 2021: [Purchase Agreement](https://web.archive.org/web/20231117185607/https://d37iydjzbdkvr9.cloudfront.net/arquivos/2021/05/12/contrato-pfizer.pdf)
**Canada**
Between Pfizer and the Minister of Public Works and Government Services Canada on behalf of [Public Services and Procurement Canada](https://www.whiteroseintelligence.com/Public-Services-and-Procurement-Canada).
- October 26, 2020: [Manufacturing and Supply Agreement](https://web.archive.org/web/20231024211245/https://img1.wsimg.com/blobby/go/9b59c1b0-ca6d-473d-a5c2-7500cca04efd/downloads/Pfizer%5FCan-0001.pdf?ver=1698118712156)
**South Africa**
Between Pfizer and the National Department of Health of South Africa.
- March 30, 2021: [Manufacturing and Supply Agreement](https://web.archive.org/web/20231020202549/https://healthjusticeinitiative.org.za/wp-content/uploads/2023/09/OCRPfizer-1%5FRedacted.pdf)
- June 4, 2021: [Amendment to Manufacturing and Supply Agreement](https://web.archive.org/web/20231025083025/https://healthjusticeinitiative.org.za/wp-content/uploads/2023/09/OCRPfizer-2%5FRedacted.pdf)
- [Binding Term Sheet](https://web.archive.org/web/20230930230908/https://healthjusticeinitiative.org.za/wp-content/uploads/2023/09/OCRPfizer-3%5Fno-sign.pdf)
## Product monographs
**Canada**
- September 28, 2023: [COMIRNATY® Omicron XBB.1.5](https://web.archive.org/web/20231110041903/https://covid-vaccine.canada.ca/info/pdf/comirnaty-omicron-xbb-1-5-pm-en.pdf)
- October 25, 2024: [COMIRNATY® Omicron KP.2](https://web.archive.org/web/20241005191245/https://covid-vaccine.canada.ca/info/pdf/comirnaty-kp2-pm-en.pdf)
## Studies
- December 11, 2020: "[BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2](https://www.biorxiv.org/content/10.1101/2020.12.11.421008v1)"
- Preprint published on bioRxiv
- February 1, 2021: “[BNT162b vaccines protect rhesus macaques from SARS-CoV-2](https://www.nature.com/articles/s41586-021-03275-y)”
- Published in *Nature*
- Winter 2024: "[Pfizer/BioNTech’s COVID-19 modRNA Vaccines: Dangerous Genetic Mechanism of Action Released before Sufficient Preclinical Testing](https://jpands.org/vol29no4/oldfield.pdf)"
- Published in the *Journal of the American Physicians and Surgeons*
- Authored by Philip R. Oldfield, [L. Maria Gutschi](https://www.whiteroseintelligence.com/Maria-Gutschi), Peter A. McCullough, and David J. Speicher
- December 3, 2024: "[BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence](https://publichealthpolicyjournal.com/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
- [Campfire Wiki](https://www.campfire.wiki/doku.php?id=pfizer-biontech%5Fcovid-19%5Fvaccine)
- [Wikipedia](https://en.wikipedia.org/wiki/Pfizer%E2%80%93BioNTech%5FCOVID-19%5Fvaccine)
- [Wikispooks](https://wikispooks.com/wiki/Pfizer%E2%80%93BioNTech%5FCOVID-19%5Fvaccine)
---
1. Scarcella, M. (2024, December 6). *FDA must disclose more COVID-19 vaccine records, US judge rules.* Reuters. [↩︎](#fnref1)
2. 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). [↩︎](#fnref2)
3. 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. [↩︎](#fnref3)
## Further reading
[A Primer on Manufacturing Process Violations and DNA ContaminationAnalysis of Pfizer-BioNTech COVID-19 Vaccine ProductionCovidLawCast.ComWarner Mendenhall](https://www.covidlawcast.com/p/a-primer-on-manufacturing-process)