HQ Team
September 1, 2024: Emergent BioSolutions Inc., got the US drug regulator’s approval to expand its smallpox vaccine use to treat mpox, according to a company statement.
The supplemental Biological License Application of Emergent was approved by the Food and Drug Administration on previously available data on the ACAM2000 vaccine on humans and animals.
The vaccine was shown to be effective in protecting against mpox virus exposure, according to the statement. Emergent announced that it will donate 50,000 doses of ACAM2000 for potential deployment across impacted countries in Central Africa.
The single-dose vaccine is administered percutaneously through a bifurcated needle that is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine.
Smallpox disease
The vaccine was first approved by the FDA in 2007 for active immunization for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection.
“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,” said Joe Papa, president and CEO of Emergent.
“Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying products currently available in inventory based on the needs, as well as the ability to increase supply.”
Emergent’s vaccine is the second such approved against mpox in the US after Bavarian Nordic’s Jynneos. The vaccine was cleared by Singapore’s medicines regulatory authority, on August 27 for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection.
European Medicines Agency
Bavarian Nordic has filed a submission to the European Medicines Agency to extend the approval to adolescents 12-17 years of age and is also working with partners, including the Coalition for Epidemic Preparedness Innovations (CEPI) to evaluate the safety and efficacy of the vaccine in children 2-12 years of age.
Bavarian Nordic has been a long-term supplier of the vaccine to national stockpiles, and during the 2022-2023 mpox outbreak, the company supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide.
United Nations Children’s Fund, the world’s largest single vaccine buyer, issued an emergency tender on August 31 to buy mpox vaccines to fight the rapid spread of the disease in the African continent.
This approval follows Emergent’s announcement that it filed an Expression of Interest with the WHO for the agency’s assessment of ACAM2000 vaccine to be added as an Emergency Use Listing in connection with the mpox outbreak.
Jenner vaccine
Emergent also is in discussions with other global public health leaders to help address the current mpox outbreak in response to the WHO’s Director-General’s August 14 statement declaring that the upsurge of mpox is a public health emergency of international concern under the International Health Regulations, according to the statement.
“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,” to combat the spread, said Dr Amesh A. Adalja, health security and emerging infectious diseases expert at Johns Hopkins Center for Health Security.
