Emergent BioSolutions says it will donate 50,000 doses of its ACAM2000 smallpox vaccine to help against the mpox outbreak in Africa.

According to Emergent, the FDA is presently reviewing a supplemental Biologics License Application (sBLA) to expand ACAM2000’s indication to include mpox immunization. The company expects the FDA to complete its review in the third quarter of 2024. Emergent has also submitted an Expression of Interest with the World Health Organization to have ACAM2000 added as an Emergency Use Listing (EUL) as a vaccine against mpox.

On Aug. 14, the WHO director declared the mpox outbreak in the Democratic Republic of the Congo to be a public health emergency of international concern. Cases increased significantly in the DRC last year amid a new virus strain, clade 1b. This year in the DRC, the number of mpox cases reported has already exceeded last year’s total, with more than 15,600 cases and 537 deaths.

“As the WHO has declared, the mpox outbreak is a public health emergency of international concern, and Emergent is ready to scale up response efforts and partner with U.S. and global public health leaders,” Emergent BioSolutions CEO Joe Papa said in a news release posted yesterday.

Mpox virus is in the same family of viruses as variola virus, the virus that causes smallpox — one of the most devastating diseases in human history. The WHO declared smallpox officially eradicated in 1980, but Emergent, over the years, has supplied ACAM2000 to the U.S. Strategic National Stockpile and other national stockpiles around the world as a contingency against a future bioterrorism attack.

Said Papa: “For years, Emergent has supplied ACAM2000 to the U.S. and allied governments in support of preparedness and stockpiling initiatives. Currently, we have additional product already in inventory, with the ability to increase supply by approximately 40 million doses, if and potentially when needed. In the meantime, 50,000 doses of ACAM2000 vaccine will be donated to help control the outbreak across the African continent.”

Bavarian Nordic, which supplied more than 15 million doses during the previous global mpox outbreak of 2022–23, announced this week that it has informed the Africa CDC that it has the capacity to make 10 million doses by the end of 2025, in addition to current orders. It added that it could already supply up to 2 million doses this year.