Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Janssen Biotech, Inc. (Janssen), for the Janssen COVID-19 Vaccine. FDA revoked the Authorization on June 1, 2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.