Pandemic Darlings The pandemic economy, in original documents
Home Source documents Emergency Use Authorization Revoked: EUA 27034, Pfizer-BioNTech COVID-19 Vaccine (Center for Biologics Evaluation and Research, FDA, August 27, 2025)

Emergency Use Authorization Revoked: EUA 27034, Pfizer-BioNTech COVID-19 Vaccine (Center for Biologics Evaluation and Research, FDA, August 27, 2025)

Summary

On August 27, 2025 the FDA notified BioNTech Manufacturing GmbH and Pfizer, Inc. that Emergency Use Authorization (EUA) 27034 for the Pfizer-BioNTech COVID-19 Vaccine was revoked. The EUA was first issued on December 11, 2020 for individuals 16 years of age and older and was last reissued on August 22, 2024 to authorize use of the 2024-2025 Formula in individuals 6 months through 11 years of age. The letter states that FDA determined circumstances make revocation appropriate to protect the public health or safety under section 564(g)(2)(C) of the Act. It notes that FDA approved Spikevax on July 9, 2025 and Comirnaty (2025-2026 Formula) on August 27, 2025, and says notice will be published in the Federal Register. It is signed by Vinayak Prasad, M.D., M.P.H., Director of the Center for Biologics Evaluation and Research.

Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used

Full text

Our Reference: EUA 27034                          EMERGENCY USE AUTHORIZATION
                                                                     REVOKED
                                                                 August 27, 2025

BioNTech Manufacturing GmbH
Attention: (b) (6)
Pfizer, Inc.
66 Hudson Boulevard East
New York, NY 10001

Dear (b) (6)        :

This letter is to notify you of the revocation of the Emergency Use Authorization (EUA)
27034 for the emergency use of Pfizer-BioNTech COVID-19 Vaccine for the prevention
of COVID-19. This EUA was initially issued on December 11, 2020, for individuals 16
years of age and older and was amended and reissued in its entirety by FDA multiple
times, most recently on August 22, 2024, to, among other things, authorize the use of
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for use in individuals 6
months through 11 years of age.

The authorization of a biological product for emergency use under section 564 of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to
section 564(g)(2) of the Act, be revised or revoked when the criteria under section
564(b)(1) of the Act no longer exist, the criteria under section 564(c) of the Act for
issuance of such authorization are no longer met, or when circumstances make such
revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the
Act).

FDA has determined that circumstances make such revocation appropriate to protect
the public health or safety (section 564(g)(2)(C) of the Act). As of July 9, 2025, there is
now an approved vaccine for use in certain individuals in the age group that is the target
of your EUA. Specifically, on July 9, 2025, FDA approved Spikevax (COVID-19 Vaccine,
mRNA) (2024-2025 Formula) for use in individuals who are 65 years of age and older,
or 6 months through 64 years of age with at least one underlying condition that puts
them at high risk for severe outcomes from COVID-19. In addition, on August 27, 2025,
FDA approved Comirnaty (COVID-19 Vaccine, mRNA) (2025-2026 Formula) for use in
individuals who are 65 years of age and older, or 5 years through 64 years of age with
at least one underlying condition that puts them at high risk for severe outcomes from
COVID-19. Prior to July 9. 2025, the only COVID-19 vaccines that were available for
use in individuals 6 months through 11 years of age were authorized under EUA.
Furthermore, widespread natural and vaccine-acquired immunity has reduced severe
outcomes, hospitalizations, and deaths from COVID-19. While safety concerns are not
the basis for our decision to revoke the EUA, due to all of these circumstances, I have


U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w w w.fda.gov
Page 2 – EUA 27034 – (b) (6)


determined that circumstances exist that make it appropriate to revoke your EUA and,
doing so is appropriate to protect the public health or safety.

Accordingly, FDA revokes EUA 27034 for emergency use of the Pfizer-BioNTech
COVID-19 Vaccine pursuant to section 564(g)(2) of the Act. As of the date of this letter,
the Pfizer-BioNTech COVID-19 Vaccine, which was authorized by FDA for emergency
use under EUA 27034, is no longer authorized by FDA.

Notice of this revocation will be published in the Federal Register, pursuant to section
564(h)(1) of the Act.

                            Sincerely,




                            Vinayak Prasad M.D., M.P.H.
                            Director
                            Center for Biologics Evaluation and Research

File and source

File
f10-r71.pdf
Size
136,686 bytes
SHA-256
c57a6c2e3e1d8dc648de146acf6ac310adc75d776323a5b2cd6d2d17fda1dd01
Our copy
f10-r71.pdf
Original
www.fda.gov
Back to top