Emergent BioSolutions (NYSE:EBS) shares jumped over 23% premarket on Friday as the U.S. Food and Drug Administration (FDA) approved expanded use of the company’s ACAM2000 smallpox vaccine to include people at high risk for mpox infection.
Earlier this month, the World Health Organization (WHO) declared the current outbreak of mpox, formerly known as monkeypox, in Africa a public health emergency of international concern.
ACAM2000, a single-dose live vaccine administered percutaneously, first gained FDA approval in 2007 for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection.
The latest approval is based on previously available human safety data and data from a well-controlled animal study, in which the vaccine was shown to be effective in protecting against mpox virus exposure. It follows Emergent’s (EBS) application for an Emergency Use Listing of ACAM2000 vaccine with the WHO.
Emergent BioSolutions (EBS) last week pledged to donate 50,000 doses of its ACAM2000 vaccine to the Democratic Republic of the Congo and other impacted countries of Burundi, Kenya, Rwanda, and Uganda to address the mpox outbreak.
