Revocation of Emergency Use of Three Biological Products; Availability
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.
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →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.