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# Emergent Bio Wins Mpox Vaccine Approval
- URL: https://www.fdaweb.com/emergent-bio-wins-mpox-vaccine-approval/
- Published: 2024-08-30T12:00:00.000Z
- Updated: 2026-09-14T14:40:03.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157689

FDA has approved an Emergent BioSolutions supplemental BLA for an expanded indication for ACAM2000, (smallpox and mpox vaccine, live) to include preventing mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available data showing that ACAM2000 is effective in protecting against mpox virus exposure, according to the company. The single-dose vaccine is administered percutaneously via a bifurcated needle that is dipped into the vaccine and the skin is then pricked several times in the upper arm.

The vaccine was originally approved by FDA in 2007 for the prevention of smallpox disease in individuals at high risk, the company says. Mpox (also known as monkeypox) is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus, the company says. “The virus is a member of the *Orthopoxvirus* genus in the *Poxviridae* family, and related to the virus which caused smallpox, which was eradicated in 1980."