Emergent BioSolutions scored an expanded FDA approval for its single-dose vaccine, ACAM2000, to now include the prevention of mpox disease in people at high risk for an infection of the virus.
The approval late Thursday was based on human safety data and data from an animal study, in which the vaccine was effective in protecting against mpox (previously called monkeypox) exposure. ACAM2000 was first approved in 2007 for smallpox disease.
“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,” Emergent president and CEO Joe Papa wrote in a statement.
An mpox outbreak in the Democratic Republic of the Congo and other countries in Africa was declared a public health emergency by WHO Director-General Tedros Adhanom Ghebreyesus earlier this month. Last week, Emergent filed an Expression of Interest with the WHO for its vaccine to be added as an Emergency Use Listing.
As part of Emergent’s response to the current mpox outbreak, the company is donating 50,000 doses of the vaccine for potential use in certain countries in Central Africa.
On Aug. 19, Papa announced that additional vaccine doses are already in inventory, with the ability to increase supply by about 40 million doses if needed.
“ACAM2000, a direct descendant of the Jenner vaccine (humanity’s first) which was used to eradicate smallpox, and now with the broadened indication, will be an invaluable tool in this endeavor,” health security and emerging infectious diseases expert at Johns Hopkins Center for Health Security Amesh Adalja wrote in a statement.