Emergent BioSolutions’ smallpox vaccine has received expanded approval from the U.S. Food and Drug Administration (FDA) for use in individuals at high risk of contracting mpox. This development led to a 5% increase in the company’s shares.
The FDA authorization makes the vaccine, ACAM2000, the second shot against mpox to be approved in the United States, following Bavarian Nordic’s Jynneos.
At the beginning of August, Emergent, which has a market value of around $471 million, projected that it would generate sales of up to $490 million from products being stockpiled by governments. These products include the smallpox vaccine and an anthrax treatment.
However, individuals with compromised immune systems, especially those infected with HIV, are not suitable candidates for the Emergent vaccine. During the mpox outbreak in the U.S. in 2022, it was only used in a limited capacity, despite being included in the national stockpile.
The vaccinia virus found in both Jynneos and ACAM2000 is closely related to the viruses responsible for smallpox and mpox, though it is considered less dangerous. The ACAM2000 vaccine uses a live, infectious strain of the vaccinia virus.
Unlike traditional injections, the Emergent vaccine is administered by making a series of tiny punctures on the skin using a needle with two prongs. A scab will form at the site, and until it heals, there is a risk that the live virus could spread to other areas of the body or to other people.
This approval comes at a critical time, as a new strain of mpox, known as clade Ib, has rapidly spread across Africa. Earlier this month, the World Health Organization (WHO) declared mpox a global health threat for the second time in two years.
Emergent has expressed its commitment to helping manage the ongoing outbreak and announced last week that it will donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo and neighboring countries.
The company has also communicated to the WHO its desire for ACAM2000 to be included on the emergency use listing. In September, the United Nations agency is expected to grant emergency listings to Jynneos and an mpox vaccine manufactured by KM Biologics of Japan.
Emergent, headquartered in Gaithersburg, Maryland, experienced a decline in its share price last year due to the weakness of its contract manufacturing sector. However, after implementing a recovery strategy that involved shifting away from that segment, the company’s shares have rebounded this year.
