Emergent BioSolutions (EBS.US) shares jumped more than 40% before the market opened on Friday after the FDA approved an expanded use of the company's ACAM2000 smallpox vaccine to allow its use in people at high risk for monkeypox infection.
Earlier this month, the World Health Organization (WHO) declared the current outbreak of monkeypox in Africa a "public health emergency of international concern."
Emergent's ACAM2000 is a single-dose, skin-applied live vaccine that was first approved by the FDA in 2007 for use in people at high risk for smallpox infection.
The latest approval was based on previously available human safety data and data from a controlled animal study in which the vaccine was shown to be effective in preventing monkeypox infection. Emergent had previously applied to WHO to have the ACAM2000 vaccine added to its emergency use authorization.
Emergent last week committed to donating 50,000 doses of ACAM2000 to countries affected by the monkeypox outbreak, including the Democratic Republic of Congo and Burundi, Kenya, Rwanda and Uganda.
Its competitor Bavarian Nordic's Jynneos vaccine is also approved in the U.S. for use against smallpox and monkeypox.