US drug agency approves nearly 800,000 monkeypox vaccines

HOUSTON, Texas

The Food and Drug Administration (FDA) approved nearly 800,000 doses of the Jynneos vaccine Wednesday to combat an outbreak of monkeypox.

Jynneos is manufactured by Bavarian Nordic in Denmark and it is used to prevent monkeypox and smallpox. The move is a big step in battling a recent outbreak of monkeypox in the US before it gets worse.

“This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox," Health and Human Services (HHS) Secretary Xavier Becerra said in a statement. "The expedited inspection and approval by FDA of Bavarian Nordic’s fill-and-finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the U.S."

With the approval of Jynneos, HHS is now working to make the doses available to all US states as soon as possible.

"Aggressively responding to the monkeypox outbreak is a critical priority for HHS," said Becerra. "Within days of the first U.S. case, we activated a multi-pronged response, significantly increasing vaccine supply and distribution, expanding access to tests, making treatments available for free, and educating the public on steps to reduce risk of infection."

HHS said it will announce allocations of the vaccine beginning Thursday.

"We will continue to accelerate and strengthen our response in the coming days, and will work with partners on the ground, in the community, and internationally to combat this virus and protect those at risk," said Becerra. "I applaud the entire FDA team for their tireless work in making this additional vaccine available as quickly as possible while ensuring it meets the highest standards of quality and safety.”