Emergent BioSolutions’ mpox vaccine approved by FDA
Emergent BioSolutions’ (NYSE: EBS) shares were up 16.44% at $10.37 pre-market on news of US regulatory clearance of its mpox vaccine.
The US Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) 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.
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