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FEDERAL REGISTER · NOTICEOctober 2, 2025NOTICE — NO LEGAL EFFECT

Revocation of Emergency Use of Three Biological Products; Availability

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

Document type
Notice
Agency
Health and Human Services Department
Published
October 2, 2025
Document number
2025-19272
ABSTRACT

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.

Abstract as published in the Federal Register.

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