In August 2024, Emergent BioSolutions announced that the US FDA has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000 to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval draws on previous human safety data and animal data, where ACAM2000 was shown to be effective in protecting against mpox virus exposure. ACAM2000 is a single-dose vaccine administered percutaneously through a bifurcated needle.
ACAM2000
ACAM2000 is the primary smallpox vaccine designated for use in a bioterrorism emergency; it is indicated in the US for active immunisation for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox and mpox infection. It was first approved by the FDA in 2007 for active immunisation for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. The FDA approval follows the announcement that Emergent has filed an Expression of Interest (EOI) with WHO for consideration for Emergency Use Listing.
Emergent’s president and CEO Joe Papa commented that the FDA approval “further strengthens and broadens” Emergent’s “industry-leading smallpox portfolio”.
“This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases. We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.”
Dr Amesh A. Adalja, FIDSA FACP FACEP, health security and emerging infectious diseases expert, Johns Hopkins Centre for Health Security, described the “enormous need to use all effective tools to extinguish” the “uncontrolled epidemic” of mpox.
“ACAM2000, a direct descendent of the Jenner vaccine (humanity’s first) which was used to eradicate smallpox, and now with the broadened indication, will be an invaluable tool in this endeavour.”
For more on the vaccine community’s efforts to address the growing threat of mpox, join us at the Congress in Barcelona this October. Don’t forget to subscribe to our weekly newsletters for vaccine updates here.
