# Revocation of Emergency Use of Three Biological Products; Availability
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUA) (the Authorizations) issued to Pfizer, Inc. for Pfizer-BioNTech COVID-19 Vaccine; to ModernaTX, Inc. for Moderna COVID-19 Vaccine; and to Novavax, Inc. for Novavax COVID-19 Vaccine, Adjuvanted. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
**DATES:**
The Authorizations for Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, and Novavax COVID-19 Vaccine, Adjuvanted are revoked as of August 27, 2025.
**ADDRESSES:**
Submit written requests for single copies of the revocations to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The revocations may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010 or emailing *[email protected].* See the *SUPPLEMENTARY INFORMATION* section for electronic access to the revocations.
**FOR FURTHER INFORMATION CONTACT:**
Andrew C. Harvan, Center for Biologics Evaluation and Research, Food and Drug Administration, 240-402-7911.
**SUPPLEMENTARY INFORMATION:**
**I. Background**
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations.
On December 11, 2020, FDA issued an EUA to Pfizer, Inc. for Pfizer-BioNTech COVID-19 Vaccine, subject to the terms of the Authorization. On December 18, 2020, FDA issued an EUA to ModernaTX, Inc. for Moderna COVID-19 Vaccine, subject to the terms of the Authorization. Notice of the issuance of these two Authorizations were published in the *Federal Register* on January 19, 2021 (86 FR 5200), as required by section 564(h)(1) of the FD&C Act. On July 13, 2022, FDA issued an EUA to Novavax, Inc. for Novavax COVID-19 Vaccine, Adjuvanted, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the *Federal Register* on August 29, 2022 (87 FR 52790), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to these three Authorizations were made available on FDA's website.
The authorization of a biological product for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act).
**II. EUA Revocation Criteria Met**
On August 27, 2025, FDA revoked the EUAs for Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, and Novavax COVID-19 Vaccine, Adjuvanted, because FDA determined that it is appropriate, for the reasons discussed below, to revoke these Authorizations under section 564(g)(2)(C) of the FD&C Act.
As more thoroughly explained in the full revocation letters, circumstances exist that make revocation of each of the EUAs appropriate to protect the public health or safety. For example, there are now approved COVID-19 vaccines for use in certain individuals that were included in the target age groups of each of these EUAs. Specifically, there are approved COVID-19 vaccines 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, widespread natural and vaccine-acquired immunity has reduced severe outcomes, hospitalizations, and deaths from COVID-19. While safety concerns were not the basis for FDA's decision to revoke the EUAs, due to various considerations, FDA determined that circumstances exist that make revocation of the EUAs appropriate to protect the public health or safety.
**III. The Revocations**
Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUAs for Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, and Novavax COVID-19 Vaccine, Adjuvanted. The revocations in their entireties follow and provide explanations of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.
**IV. Electronic Access**
An electronic version of this document and the full text of the Authorizations and revocations are available on the internet at *https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.*
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.