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In a significant development, the U.S. Food and Drug Administration (FDA) has expanded the approved use of Emergent BioSolutions’ ACAM2000 smallpox vaccine to include individuals at high risk for mpox infection. This decision, announced on Thursday, comes as the World Health Organization (WHO) recently declared mpox a global public health emergency, driven by the rapid spread of a new virus variant, clade Ib, in Africa.
The FDA’s move follows Emergent’s application for an Emergency Use Listing of ACAM2000 with the WHO, underscoring the urgency to address the escalating mpox outbreak. The expansion of ACAM2000’s use is particularly notable as global health authorities scramble to contain the spread of the virus.
Emergent BioSolutions also announced its commitment to global health by donating 50,000 doses of the ACAM2000 vaccine to several African nations, including the Democratic Republic of the Congo, Burundi, Kenya, Rwanda, and Uganda. These donations are aimed at bolstering the fight against the mpox outbreak in regions where the new variant is spreading rapidly.
However, the use of ACAM2000 is not without concerns. The U.S. Centers for Disease Control and Prevention (CDC) has highlighted that ACAM2000 carries more known side effects and risks compared to the Jynneos vaccine, developed by Bavarian Nordic A/S, which is also used for mpox prevention. ACAM2000, being a live virus vaccine, has been linked to heart-related conditions such as myocarditis and pericarditis, occurring in approximately 1 out of 175 new recipients, according to FDA data.
As the global health community continues to grapple with the challenges posed by mpox, the expanded use of ACAM2000 provides an additional tool in the fight against this emerging public health threat. However, the balance between its efficacy and potential risks will be closely monitored as the vaccine is deployed to protect high-risk populations worldwide.
