The U.S. Food and Drug Administration (FDA) has granted expanded approval for Emergent BioSolutions’ smallpox vaccine, ACAM2000, to be used in individuals at high risk of mpox infection. This approval, announced by the company late Thursday, positions ACAM2000 as the second vaccine authorized in the U.S. for mpox, following Bavarian Nordic’s Jynneos.
Emergent BioSolutions, which has a market capitalization of approximately $471 million, recently projected sales of up to $490 million from government-stockpiled products like the smallpox vaccine and an anthrax shot. Despite its availability, ACAM2000 saw limited use during the 2022 mpox outbreak in the U.S., largely because it cannot be administered to individuals with weakened immune systems, including those with HIV.
Both ACAM2000 and Jynneos are derived from the vaccinia virus, a less harmful relative of the viruses responsible for smallpox and mpox. However, unlike Jynneos, which is given as a standard injection, ACAM2000 is administered through multiple small punctures in the skin using a two-pronged needle. The vaccination site forms a scab, which carries a risk of spreading the live virus to other parts of the body or to other people until it fully heals.
The FDA’s approval comes amid the rapid spread of a new mpox strain, clade Ib, in Africa. Earlier this month, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years, highlighting the urgency of expanding vaccine options.
Despite a brief surge in its stock price following the FDA announcement, Emergent BioSolutions’ shares fell after the WHO disclosed that it is reviewing emergency license applications for two other mpox vaccines produced by Bavarian Nordic and Japan’s KM Biologics.
Last week, Emergent expressed interest in securing an emergency license from the WHO for its vaccine and confirmed that it is actively engaging with the global health agency to support its application. Additionally, the company announced plans to donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo and neighboring countries.
Emergent BioSolutions, headquartered in Gaithersburg, Maryland, faced challenges last year due to weaknesses in its contract manufacturing business. However, the company has seen a recovery this year, driven by a strategic shift away from that segment. Despite these recent developments, Emergent’s shares were down 5% at $8.43, a significant drop from their peak of over $130 during the height of the COVID-19 pandemic when the company was a contract manufacturer for Johnson & Johnson’s vaccines.
