FDA Authorizes Emergency Use of Monkeypox Vaccine

The World Health Organization declared the monkeypox (MPV) outbreak a global health emergency last month. Then, President Biden’s administration declared the disease a public health emergency in the U.S. on Thursday. Now, the Food and Drug Administration has authorized emergency use of the Jynneos vaccine against the disease, increasing a strained supply by five-fold.

"In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand," said FDA Commissioner Robert M. Califf, M.D. in a statement. "The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so."

The emergency use authorization will open up vaccine supplies to those deemed at high-risk for MPV, typically sexually-active men who have sex with men, and include both adults and high-risk adolescents. By declaring an emergency use authorization, the FDA is allowing for a fraction of the typical Jynneos dose — about one-fifth — to be administered between the layers of the skin as opposed to a full dose injected into underlying fat. Two doses of the vaccine, given four weeks apart, will still be needed.

President Biden recently named Dr. Demetre Daskalakis, a veteran emergency response official and a respected infectious disease specialist who has overseen HIV prevention efforts by the Centers for Disease Control and Prevention, to help coordinate the MPV response from the White House — a sign that the administration is stepping up its efforts. Biden selected FEMA's Robert Fenton as coordinator and Daskalakis as deputy coordinator.

Daskalakis said that the administration is reaching out to community-based organizations that don’t serve only major cities to reach people at risk for MPV infection.

He said that through “having engagement, especially in the LGBTQ space with LGBTQ centers, many of which serve rural areas,” the administration seeks to provide MPV outreach to members of at-risk communities, wherever they are.

The CDC reported nearly 9,500 confirmed cases of MPV in the U.S. as of Tuesday, with New York State counting over 2,100 cases and California over 1,300.