By Christy Santhosh
(Reuters) -The U.S. Food and Drug Administration granted expanded approval to Emergent BioSolutions' smallpox vaccine for use in people at high risk of mpox infection.
The FDA clearance, announced late on Thursday by the company, makes the vaccine the second approved shot against mpox in the U.S. after Bavarian Nordic's Jynneos.
Emergent, which has a market capitalization of about $471 million, in early August forecast sales of up to $490 million from products that are stockpiled by governments, such as the smallpox vaccine and an anthrax shot.
Emergent's vaccine, called ACAM2000, however, cannot be administered to those with weakened immune systems, including people with HIV. It found limited use during the 2022 mpox outbreak in the United States, despite being part of the country's stockpile.
Both Jynneos and ACAM2000 contain vaccinia virus that is closely related to, but less harmful than the viruses that cause smallpox and mpox. ACAM2000 uses a live, infectious form of the vaccinia virus.
Instead of an injection, the Emergent shot is given through a series of small pokes on the skin using a two-pronged needle. The site forms a scab and risks spreading the live virus to other parts of the body or people until it heals.
Still, the approval comes at a time when a new mpox strain, clade Ib, has spread rapidly in Africa. The World Health Organization earlier this month declared mpox a global public health emergency for the second time in two years.
Emergent's shares were up more than 10% in early trade on Friday, but fell after the World Health Organization said in a press conference it is currently reviewing applications for emergency licenses for two mpox vaccines made by Bavarian Nordic and Japan's KM Biologics.
Last week, Emergent said it sent a letter to the WHO about emergency license interest for its vaccine. The company added on Friday that it was actively engaging with the global health agency to submit information backing the letter.
Emergent had also said last week that it would donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo and neighboring countries.
The Gaithersburg, Maryland-based company's shares slumped last year amid weakness in its contract manufacturing business, but have recovered this year on the back of a turnaround plan that includes pivoting away from that segment.
They were last down 5% at $8.43. The stock traded at more than $130 at the peak of the pandemic, when the company was a contract manufacturer of Johnson & Johnson (NYSE:JNJ)'s COVID-19 vaccines.