FDA Expands Use of Smallpox Vaccine for Mpox Prevention

The U.S. FDA has approved the use of Emergent BioSolutions' ACAM2000 smallpox vaccine for individuals at high risk of mpox. Following WHO's recent global health emergency declaration, Emergent is donating 50,000 doses to affected African countries. ACAM2000 may cause heart-related side effects, per the CDC.

The U.S. Food and Drug Administration (FDA) has expanded the use of Emergent BioSolutions' ACAM2000 smallpox vaccine to include people at high risk for mpox infection, the company announced on Thursday.

This move comes after the World Health Organization recently declared mpox a global public health emergency as a new virus variant, clade Ib, spreads rapidly in Africa. The FDA approval is in response to Emergent's application for an Emergency Use Listing of ACAM2000 with the WHO.

Emergent BioSolutions also revealed that it would be donating 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo, Burundi, Kenya, Rwanda, and Uganda to help tackle the mpox outbreak. However, the U.S. CDC notes that ACAM2000 has more known side effects and risks compared to the Jynneos vaccine by Bavarian Nordic A/S.

ACAM2000, a live virus vaccine, has been associated with heart-related conditions such as myocarditis and pericarditis, occurring in 1 out of 175 new recipients, according to FDA data.