FDA signs off on Bavarian Nordic plant, allowing distribution of monkeypox vaccine doses

Dive Brief:

• The U.S. government said another 786,000 doses of monkeypox vaccine are now available for use after the Food and Drug Administration signed off on a plant in Denmark used in their manufacturing.
• In anticipation of the clearance, the U.S. had already imported the doses made by Denmark’s Bavarian Nordic so they could be distributed right away. “The inspection and evaluation were necessary work to help ensure the quality and safety of the vaccine,” the FDA said on Twitter Thursday.
• Bavarian Nordic said it now has approval from both U.S. and EU regulators for the facility, which formulates the vaccine and fills it into vials. The clearance means the company can ship the shots directly into U.S. and European markets.

Dive Insight:

Governments all over the world are racing to confront the latest epidemic, dubbed a public health emergency of international concern by the World Health Organization on July 23. On July 25, the European Commission expanded the marketing authorization for Bavarian Nordic’s vaccine to include monkeypox, shaving weeks off its usual review time.

The FDA had been under pressure to untangle what The New York Times described as “bureaucratic red tape” at the Denmark plant, holding up hundreds of thousands of doses. U.S. government officials have also faced criticism that they didn’t move fast enough to distribute about 300,000 already-cleared doses of the Jynneos vaccine, which is approved in the U.S. to prevent both monkeypox and smallpox.

Health and Human Services Secretary Xavier Becerra said his department is working to get the latest batch of shots out to states and local jurisdictions as quickly as possible. More than 4,600 cases of monkeypox have been reported in the U.S., out of some 21,000 worldwide, according to the Centers for Disease Control and Prevention.

With vaccines targeted toward the most at-risk groups, authorities might still be able to contain monkeypox. It’s not spread through the air like the coronavirus behind COVID-19. Instead, transmission occurs most commonly through close physical contact, including during sex and via the disease’s characteristic skin lesions, as well as through contact with items that previously touched the rash or body fluids.

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