HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines

U.S. Health and Human Services (HHS) Secretary Xavier Becerra today took action that will allow the U.S. Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines, following the Aug. 4 declaration of a public health emergency for monkeypox. Specifically, the Secretary issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act (FD&C) that circumstances justify emergency use authorization of vaccines.

“Last week, I declared monkeypox to be a public health emergency to unlock additional tools that will help us contain and end this outbreak and to signal to the American people that we are taking our response to the next level,” said Secretary Becerra. “Today’s action will allow FDA to exercise additional authorities that may increase availability of vaccines to prevent monkeypox while continuing to ensure the vaccine meets high standards for safety, effectiveness and manufacturing quality.”

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.

Today’s action is the latest step the Biden-Harris Administration has taken to respond to the ongoing spread of the monkeypox virus in the United States. Within two days of the first confirmed case in the U.S., the Administration began making vaccines and treatments available to states and other jurisdictions for free.

To date, HHS has made more than 1.1 million doses of the JYNNEOS vaccine available to order and, so far, has shipped more than 620,000 doses. HHS also has made the smallpox ACAM2000 and smallpox treatment TPOXX available for states and other jurisdictions to order. Through partnerships with the country’s largest commercial laboratories, testing capacity has increased rapidly to more than 80,000 per week as HHS continues to communicate important public health messages and raise awareness with key stakeholders.