Thursday, the FDA approved Emergent BioSolutions Inc.'s (NYSE: EBS) supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection.
The approval is based on previously available human safety data and data from a well-controlled animal study in which the ACAM2000 vaccine was shown to be effective in protecting against mpox virus exposure.
ACAM2000 is a single-dose vaccine administered percutaneously via a bifurcated needle dipped into the vaccine solution, and the skin is pricked several times in the upper arm with a droplet of the vaccine.
The vaccine was first approved by the FDA in 2007 for active immunization to prevent smallpox disease in individuals at high risk for smallpox infection.
Mpox is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus.
This approval follows Emergent's announcement that it filed an Expression of Interest with the World Health Organization for the WHO's assessment of the ACAM2000 vaccine to be added as an Emergency Use Listing in connection with the mpox outbreak.
As part of its support for the response, Emergent announced that it will donate 50,000 doses of ACAM2000 for potential deployment in impacted countries in Central Africa.
ACAM2000 is the primary smallpox vaccine designated for use in a bioterrorism emergency, with doses having been supplied to the U.S. Strategic National Stockpile. ACAM2000 is also licensed in Canada, Australia, and Singapore and is currently stockpiled in the U.S. and internationally.
Reuters also noted that Nigeria received 10,000 doses of the mpox vaccine from the U.S. Agency for International Development, the first batch of the vaccine to reach the country, which has confirmed 40 cases with no fatalities.
Muyi Aina, executive director of the National Primary Health Care Development Agency, said, "We are aware that the vaccine is not exactly in surplus supply. I believe we're getting 10,000 of the about 200,000 doses that are available globally."
Price Action: At last check on Friday, EBS stock was up 15.70% at $10.31 during the premarket session.