Gaithersburg’s Emergent BioSolutions wins FDA approval for mpox vaccine

Gaithersburg, Maryland-based Emergent BioSolutions has received Food and Drug Administration approval for use of its existing smallpox vaccine as a vaccine for the mpox virus.

The vaccine, known as ACAM2000, is a single-dose vaccine that was originally approved by the FDA in 2007 for immunization against smallpox. Mpox, previously called monkeypox, is related to the virus which causes smallpox.

FDA approval for immunization against mpox is for high-risk individuals. Emergent has filed for a similar approval with the World Health Organization and is in discussions with other public health organizations.

Emergent has already announced that it will donate 50,000 doses of ACAM2000 for use across countries in central Africa that have seen an mpox outbreak.

Emergent BioSolutions cut hundreds of jobs this spring as part of a broad restructuring that also included closing some manufacturing facilities. The company named former Bausch + Lomb CEO Joseph Papa as its new chief executive in February to lead its restructuring.

Its most high-profile business is selling over-the-counter opioid overdose antidote Narcan.

Emergent also supplies government stockpiles of vaccines, including BioThrax, its anthrax vaccine.