Emergent BioSolutions has received the US Food and Drug Administration (FDA) approval for the expansion of the indication for ACAM2000 its live smallpox and mpox vaccine.
ACAM2000 is a single-dose vaccine administered using a bifurcated needle dipped into the vaccine solution and the skin is pricked several times with a droplet of the vaccine.
In 2007, the vaccine was first approved in the US, for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection.
The current FDA approval expands its indication to include individuals at high risk for mpox infection.
The US health agency approved the company’s supplemental Biologics License Application (sBLA), based on existing human safety data and data from a well-controlled animal study.
Previously known as monkeypox, Mpox is an infectious disease endemic to central and west Africa, caused by the double-stranded DNA mpox virus.
ACAM2000 is currently indicated for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox and mpox infection, said Emergent.
Emergent president and CEO Joe Papa said: “The FDA approval of ACAM2000 for immunisation against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV and TEMBEXA.
“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 products currently available in inventory based on the needs, as well as the ability to increase supply.”
Earlier this month, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years, as a new variant is rapidly spreading in Africa.
The expanded approval follows Emergent’s filing of Expression of Interest (EOI) with the WHO seeking an Emergency Use Listing of its ACAM2000 vaccine.
Last week, Emergent announced its plans to donate 50,000 doses of ACAM2000 for potential deployment across impacted countries in Central Africa.
The ACAM2000 vaccine is contraindicated for people with severe immunodeficiency.
Also, the vaccine is warned for several side effects, including myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalised vaccinia, severe vaccinial skin infections, and eczema vaccinatum, among others.
