To address the mpox infection, the US Food and Drug Administration (FDA) has approved the expanded use of Emergent BioSolutions’ ACAM2000 smallpox vaccine to include individuals at high risk for the disease, the company announced on Thursday.
Earlier this month, the World Health Organization declared mpox a global public health emergency for the second time in two years, following the rapid spread of a new variant of the virus, known as clade Ib, in Africa.
The FDA’s approval comes after Emergent BioSolutions applied for an Emergency Use Listing of the ACAM2000 vaccine with the World Health Organization.
Last week, Emergent announced it would donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo, as well as to Burundi, Kenya, Rwanda, and Uganda, to help combat the mpox outbreak.
According to the US Centers for Disease Control and Prevention, ACAM2000 has more known side effects and risks compared to the Jynneos vaccine from Danish biotech firm Bavarian Nordic A/S, which is approved in the United States for both smallpox and mpox.
The FDA reports that ACAM2000, a live, replicating virus vaccine, can cause myocarditis or pericarditis—swelling in or around the heart muscle—in about 1 in 175 new recipients.
