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.
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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.
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By GlobalDataThe 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.
The company pledged to donate 50,000 doses of ACAM2000 to aid affected regions in Central Africa.
As the primary vaccine for smallpox in the event of a bioterrorism emergency, it is a critical component of the US Strategic National Stockpile.
The vaccine is also licensed in Canada, Australia and Singapore, with stockpiles maintained both domestically and internationally, ensuring readiness against potential bioterrorism threats and disease outbreaks.
Emergent BioSolutions president and CEO Joe Papa stated: “The FDA approval of ACAM2000 for immunisation against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV and TEMBEXA.
“This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases.”
The company recently finalised the sale of its Baltimore-Camden manufacturing site to the Taiwanese company Bora Pharmaceuticals.
