[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Notices]
[Pages 47767-47774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-3792]
Revocation of Emergency Use of Three Biological Products;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
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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.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19272 Filed 10-1-25; 8:45am]
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