Emergent BioSolutions, working with the World Health Organization and the U.S. government to help address the current mpox outbreak across Central Africa, has pledged to donate 50,000 doses of its ACAM2000 vaccine.
The vaccines will be donated through the humanitarian organization Direct Relief, that has a history of providing medicines to the Democratic Republic of the Congo, as well as the other impacted countries of Burundi, Kenya, Rwanda and Uganda.
Emergent's ACAM2000 was approved in 2007 for immunization against smallpox disease for persons determined to be at high risk for infection. The second-generation smallpox vaccine doesn't yet have the FDA nod for mpox, but Emergent filed an sBLA with the agency last October seeking the expanded indication.
The shot, however, comes with risks. The live virus vaccine is administered via a two-pronged stainless steel needle that pricks the skin several times in the upper arm with a droplet of the vaccine. If successful, a red, itchy sore spot at the site of the vaccination will appear within a few days. Those who receive the vaccine can spread the virus used, a pox virus known as vaccinia, to themselves or others through contact with the vaccine site. Additionally, the vax shouldn't be administered to those who weakened immune systems, such as those with HIV, and can cause myocarditis and pericarditis.
Bavarian Nordic also has a live, non-replicating smallpox and monkeypox vaccine, branded Jynneos in the U.S. and Imvamune/Imvanex internationally, approved by the FDA in 2019.
Following the WHO declaring the mpox outbreak a public health emergency of international concern, the Danish drugmaker ramped up manufacturing capacity, promising it could manufacture 10 million doses by the end of 2025, in addition to current orders.