FDA Expands Approval of Emergent BioSolutions' Vaccine for Mpox

The U.S. FDA has expanded approval of Emergent BioSolutions' smallpox vaccine for people at high risk of mpox infection. This makes it the second approved mpox vaccine in the U.S. Although effective, the vaccine cannot be administered to individuals with weakened immune systems. Emergent is actively engaging with the WHO for emergency licenses.

The U.S. Food and Drug Administration has granted expanded approval to Emergent BioSolutions' smallpox vaccine for individuals at high risk of mpox infection. The FDA clearance, announced late Thursday by the company, positions the vaccine as the second approved shot against mpox in the U.S., following Bavarian Nordic's Jynneos.

Emergent BioSolutions, which holds a market capitalization of approximately $471 million, had forecasted sales of up to $490 million in early August from government-stockpiled products, such as the smallpox and anthrax vaccines. However, the company's vaccine, ACAM2000, is not suitable for individuals with weakened immune systems, including those with HIV. The vaccine saw limited use during the 2022 mpox outbreak in the United States, despite being a part of the national stockpile.

Both Jynneos and ACAM2000 carry the vaccinia virus, which is closely related to but less harmful than the smallpox and mpox viruses. ACAM2000, which uses a live, infectious form of the vaccinia virus, is administered through a series of small skin pokes using a two-pronged needle. The application site forms a scab, posing a risk of spreading the live virus to other body parts or individuals until it heals.

This FDA approval comes amidst the rapid spread of a new mpox strain, clade Ib, in Africa. The World Health Organization declared mpox a global public health emergency earlier this month for the second time in two years. Emergent's stock saw a 10% rise in early trading on Friday but declined following the WHO's announcement that it is reviewing emergency license applications for two mpox vaccines by Bavarian Nordic and Japan's KM Biologics.

Emergent recently informed the WHO of its interest in securing an emergency license for its vaccine. The company stated on Friday that it is actively engaging with the global health agency to support its application. Additionally, Emergent has pledged to donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo and nearby countries.

The Gaithersburg, Maryland-based company's shares slumped last year due to weaknesses in its contract manufacturing business. However, shares have rebounded this year thanks to a turnaround strategy that includes moving away from that segment. Most recently, shares were down 5% at $8.43, a significant drop from their more than $130 peak during the pandemic when the company was manufacturing Johnson & Johnson's COVID-19 vaccines.

(With inputs from agencies.)