Emergent BioSolutions will donate 50,000 doses of its smallpox vaccine to African countries experiencing an outbreak of mpox. In an animal study, the company's vaccine was shown to be effective in protecting against mpox.
The shot—ACAM2000—has been submitted to the FDA as a potential option to immunize against mpox, which the World Health Organization (WHO) declared last Wednesday as a global emergency.
The regulatory agency’s review of the application is expected to be completed by the end of the third quarter this year, Emergent BioSolutions said in an Aug. 19 press release.
Additionally, the Maryland-based biotech accepted the WHO’s call for mpox vaccine manufacturers to submit expressions of interest for the health organization’s assessment to use unlicensed medical products to speed availability of countermeasures to address public health emergencies.
“For years, Emergent has supplied ACAM2000 to the U.S. and allied governments in support of preparedness and stockpiling initiatives,” Joe Papa, Emergent’s president and CEO, said in the release. “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 and distributed through Direct Relief, a relief organization that provides vital medicines to the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda.
The Africa Centres for Disease Control and Prevention has estimated that 10 million doses of mpox vaccines will be needed to control the epidemic on the African continent.
The current outbreak includes 13 countries in Africa, with 96% of the cases located in Congo. Of the 17,000 cases this year in Africa, there have been 512 deaths. Two strains have been found—clade 1 and clade 1b—which are more deadly and disproportionately affect children.
Danish biotech Bavarian Nordic, which helped curb the prior mpox outbreaks in 2022 and 2023, said it can ramp up manufacturing of its Jynneos vaccine to supply 2 million doses this year and 8 million in 2025 to help contain the virus.