Emergent BioSolutions’ Acam2000 (smallpox and mpox (Vaccinia) vaccine, live) receives US FDA approval for mpox indication

Emergent BioSolutions

29 August 2024 - Emergent BioSolutions today announced that the US FDA has approved the supplemental biologics license application for the expansion of the indication for Acam2000 (smallpox and mpox (Vaccinia) vaccine, live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. 

The approval is based on previously available human safety data and data from a well-controlled animal study in which Acam2000 vaccine was shown to be effective in protecting against mpox virus exposure.

Read Emergent BioSolutions press release

Michael Wonder

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Michael Wonder

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Outcome , US , Vaccine , Public health