HHS secretary issues 564 determination

Aug. 10, 2022
Paving way for emergency use authorization of monkeypox vaccines.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act (FD&C) that circumstances justify emergency use authorization of vaccines.

HHS Assistant Secretary for Preparedness and Response Dawn O’Connell requested that the Secretary issue the Section 564 determination and last week’s public health emergency declaration. This declaration allows HHS to take emergency measures based on the information currently available about the monkeypox virus.

HHS release