Emergent BioSolutions' ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa & Other Regions

Core Viewpoint - Emergent BioSolutions Inc. has received FDA approval for the supplemental Biologics License Application (sBLA) to expand the indication of ACAM2000® vaccine for the prevention of mpox disease in high-risk individuals, based on human safety data and controlled animal studies [1][4]. Company Overview - Emergent BioSolutions is focused on public health threats, providing vaccines and therapeutics, and has a portfolio that includes ACAM2000®, VIGIV®, and TEMBEXA® [4][11]. - The company has filed an Expression of Interest (EOI) with the WHO for ACAM2000® to be considered for Emergency Use Listing amid the mpox outbreak [4]. Product Details - ACAM2000® is a single-dose vaccine administered via a bifurcated needle and was initially approved in 2007 for smallpox prevention [2][3]. - The vaccine is now indicated for both smallpox and mpox prevention in high-risk individuals [8]. Market Context - The WHO has declared mpox a public health emergency of international concern, with a significant increase in cases, particularly in Central Africa [5][6]. - In 2022, there were over 95,000 mpox cases reported globally across 115 non-endemic countries [5]. Public Health Response - Emergent BioSolutions plans to donate 50,000 doses of ACAM2000® for deployment in affected regions in Central Africa [4]. - The company is actively engaging with global health leaders to address the mpox outbreak [4].