Emergent BioSolutions gets FDA approval for ACAM2000 mpox indication

Emergent BioSolutions Inc.

FDA approved sBLA for ACAM2000 to prevent mpox in high-risk individuals based on animal study safety/efficacy data.
ACAM2000 is a single-dose, percutaneously administered smallpox vaccine first approved in 2007.
Emergent will donate 50,000 doses for potential deployment across impacted Central African countries.
Company filed Expression of Interest with WHO for Emergency Use Listing amid mpox outbreak.

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