Revocation of Emergency Use of Three Biological Products; Availability

Resumen

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.