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Emergent gains FDA approval for ACAM2000 vaccine for Mpox

Emergent BioSolutions has received approval from the US Food and Drug Administration (FDA) for its supplemental biologics licence application for ACAM2000, (Smallpox and Mpox (Vaccinia) Vaccine, Live), expanding its use to include the prevention of Mpox.

The single-dose vaccine, administered percutaneously via a bifurcated needle, is indicated for use in individuals at high risk for mpox infection. The FDA’s approval of the ACAM2000 vaccine for Mpox is based on existing human safety data and a comprehensive animal study demonstrating its efficacy. ACAM2000 was first licensed for active immunisation for smallpox disease prevention in 2007.

Mpox, formerly known as monkeypox, is a viral disease native to Central and West Africa. The double-stranded DNA virus belongs to the Orthopoxvirus genus within the Poxviridae family and is related to the virus that caused smallpox, which was eradicated in 1980.

The recent FDA approval aligns with Emergent’s efforts to support global health, including an Expression of Interest submitted to the World Health Organization (WHO) for emergency use assessment.

Following the WHO’s declaration of the Mpox outbreak as a public health emergency of international concern, Emergent is actively engaging with global health regulators.

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