Mpox Vaccine: Emergent BioSolutions' Smallpox Vaccine Gets FDA Nod For Expanded Use For Individuals At High Risk Of Mpox Infection
EBSEmergent BioSolutions(EBS) Benzinga·2024-08-30 19:43

Thursday, the FDA approved Emergent BioSolutions Inc.'s EBS 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 the ACAM2000 vaccine was shown to be effective in protecting against mpox virus exposur ...