September 2024
ACAM2000 (smallpox and mpox replication-competent vaccinia virus vaccine; Emergent BioSolutions) is now FDA-approved as a single percutaneous dose for the prevention of mpox in persons at high risk for mpox virus infection, in addition to the existing indication for smallpox. ACAM2000 was previously authorized for the prevention of mpox under an FDA Emergency Use Authorization. This approval is based on previously available data from human and animal studies that showed ACAM2000 was effective in protecting against mpox virus exposure.
