Emergent BioSolutions announced in August 2024 that it is “proactively” working with WHO and the US government in response to the outbreak of mpox in Africa and has pledged to donate 50,000 doses of ACAM2000. The donation will be delivered with Direct Relief, a humanitarian relief organisation that has a “long history” of providing medical interventions to the Democratic Republic of the Congo (DRC) and other affected countries.
ACAM2000
ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) is the primary smallpox vaccine designated for use in a “bioterrorism emergency”. Doses have been supplied to the US Strategic National Stockpile. It is indicated for active immunisation against smallpox disease for persons determined to be at high risk for infection. It is a single-dose vaccine administered via a bifurcated needle.
Emergent filed a supplemental Biologics License Application (sBLA) to the US FDA in 2023 to seek an expanded indication for ACAM2000 vaccine to include immunisation against mpox virus. This application includes human safety data and animal study data showing that ACAM2000 was effective in protecting against mpox virus exposure. Emergent has also responded to WHO’s invitation for an Expression of Interest for Emergency Use Listing.
Meeting demand
Dr Raina McIntyre, Professor of Global Biosecurity, NHMRC L3 Research Fellow, Head Biosecurity Programme, Kirby Institute, University of New South Wales Sydney, believes it will be “unlikely” that there will be enough supply of 3rd generation vaccines to control the epidemic in Africa, “given the demand in other countries”.
President and CEO, Emergent BioSolutions, emphasised that Emergent is “ready to scale up response efforts and partner with US and global public health leaders”. He reflected that “for years” the company has supplied ACAM2000 to the US and allied governments in “support of preparedness and stockpiling initiatives”.
“Currently, we have additional product already in inventory, with the ability to increase supply by approximately 40 million doses, if and potentially when needed. In the meantime, 50,000 doses of ACAM2000 vaccine will be donated to help control the outbreak across the African continent.”
Mr Papa concluded that increasing outbreaks of mpox around the world “should raise concerns and spur ongoing efforts” to produce and stockpile vaccines and other interventions to address all orthopoxviruses.
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