WASHINGTON: The US Food and Drug Administration (FDA) has expanded the approval of Emergent BioSolutions’ ACAM2000 smallpox vaccine to include individuals at high risk for mpox infection. Earlier this month, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years due to the rapid spread of a new variant of the virus, known as clade Ib, in Africa.
The FDA’s approval follows Emergent’s application for an Emergency Use Listing of the ACAM2000 vaccine with the World Health Organization (WHO). Last week, Emergent announced plans to donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo and other affected countries, including Burundi, Kenya, Rwanda, and Uganda, to help combat the mpox outbreak.
According to the US Centers for Disease Control and Prevention (CDC), the ACAM2000 vaccine has more known side effects and risks compared to Bavarian Nordic A/S’s Jynneos vaccine, which is approved in the US for both smallpox and mpox.
ACAM2000, a live, replicating virus vaccine, is known to cause myocarditis and pericarditis—inflammation in or around the heart muscle—in approximately 1 in 175 new recipients, according to the FDA.
