Authorizations of Emergency Use of Certain Drugs and Biological Products During the COVID-19 Pandemic; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the issuance of three Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), for use during the COVID-19 pandemic. FDA has issued one Authorization for a biological product as requested by AstraZeneca Pharmaceuticals LP (AZ), one Authorization for a drug product as requested by Pfizer, Inc. (Pfizer), and one Authorization for a drug product as requested by Merck Sharp & Dohme Corp. (Merck). The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID- 19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.