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Reported Earlier, Emergent BioSolutions' ACAM2000 Vaccine Gains FDA Nod For Mpox Indication Amidst Rising Public Health Crisis

Author: Benzinga Newsdesk | August 30, 2024 04:03am

Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has 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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