2022-21834: Authorization of Emergency Use of a Biological Product in Response to an Outbreak of Monkeypox; Availability

Summary

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of monkeypox. FDA has issued one Authorization for a biological product as requested by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of the Department of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States (U.S.) citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on August 9, 2022, that circumstances exist justifying the authorization of emergency use of vaccines pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The agency’s own summary, as published.