The Food and Drug Administration said Wednesday it approved changes to the license for a critical monkeypox vaccine, clearing the way for 786,000 doses to be distributed in the U.S.
Regulators amended the biologics license for the Jynneos vaccine manufactured by Bavarian Nordic.
Release of the doses is viewed as a critical step in the monkeypox response as New York City and other locales complain they are running out of vaccine doses swiftly, sparking anger in the hard-hit LGBT community and frustration among medical professionals.
Health and Human Services Secretary Xavier Becerra applauded the FDA’s action.
“HHS is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs and will announce allocations tomorrow,” he said. “Aggressively responding to the monkeypox outbreak is a critical priority for HHS.”
Monkeypox is endemic to parts of Africa, but it has been spreading in dozens of other countries, including the U.S., since mid-spring. It is rarely fatal but features a painful rash.
The U.S. has recorded nearly 3,600 cases — including 900 in New York state, which is considered the epicenter of the outbreak in this country.
Many of the cases have been found in men who have sex with men, although the virus can spread to anyone through close personal contact.