FDA Approves Expanded Use of ACAM2000 Vaccine for Mpox Amid Public Health Emergency
Emergent BioSolutions has announced that it will donate 50,000 doses of ACAM2000 for potential deployment across affected areas in Central Africa.
The FDA has approved a supplemental biologics license application for the expansion of the indication for ACAM2000 to include prevention of mpox disease in individuals at high risk for infection, developer Emergent BioSolutions announced in a news release.1
Close up mpox virus pathogen / dottedyeti - stock.adobe.com
Previously, the indication was limited to the prevention of smallpox.
The approval is supported by existing human safety data and animal studies demonstrating the vaccine’s effectiveness against mpox virus exposure.1 It follows Emergent’s filing of an expression of interest with the WHO for emergency use listing of ACAM2000 to address the ongoing mpox outbreak, which was declared a public health emergency of international concern by the agency on August 14.2
“The FDA approval of ACAM2000 for immunization against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV and TEMBEXA,” said Joe Papa, president and CEO of Emergent, in the release.1 “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.”
ACAM2000 is a single-dose skin-prick vaccine administered percutaneously using a bifurcated needle dipped in vaccine solution.
READ MORE: Despite Success of Vaccines for Children Program, Disparities Persist
In 2022, the WHO declared the first mpox public health emergency of international concern, a global event that led to the spread of more than 95,000 cases across 115 non-endemic areas.3 Whereas the first emergency was brought on by clade II mpox, which has a survival rate of 99.9%,4 the second and current emergency is due to the newer clade 1b strain.
According to the WHO, clade I tends to cause a higher number of severe infections and have a higher mortality rate than clade II.2 As the bulk of cases are concentrated in Central Africa, infection and death rates in the Democratic Republic of Congo have already surpassed last year’s count with more than 15,600 cases and 537 deaths recorded.5
Most human-to-human mpox transmission has occurred within households, health care settings, and through sexual contact, especially among men who have sex with men and sex workers. However, the fact that the majority of cases and deaths in the current mpox outbreak are in children suggests that transmission is happening through methods other than sexual contact.5 This highlights the importance of enhanced surveillance, testing, contact tracing, and public health tools to effectively manage the outbreak.
Emergent BioSolutions has announced that it will donate 50,000 doses of ACAM2000 for potential deployment across affected areas.1
“Mpox has progressed to become an uncontrolled epidemic in Africa—prompting the WHO to declare a second public health emergency of international concern—creating an enormous need to use all effective tools to extinguish it as a threat,” said Amesh A. Adalja, MD, FIDSA, FACP, FACEP, and health security and emerging infectious disease expert at Johns Hopkins Center for Health Security, in the same release.1 “ACAM2000, a direct descendant 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 endeavor.”
Currently, ACAM2000 is the primary smallpox vaccine designated for use in a bioterrorism emergency.1 It is also licensed in Canada, Australia, and Singapore and stockpiled both in the US and internationally.
READ MORE: Immunization Resource Center
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