HHS Secretary paves way for emergency use authorization of monkeypox vaccines

US Health and Human Services (HHS) Secretary Xavier Becerra yesterday took action that will allow the US Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines, following the August 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, adding: “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.”

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