FDA Approves Emergent BioSolutions' Smallpox Vaccine for mpox High-Risk Groups

The U.S. FDA has widened approval for Emergent BioSolutions' smallpox vaccine, ACAM2000, to include those at high risk of mpox infection. Despite limitations, this approval elevates the vaccine as a crucial measure against the outbreak. Emergent plans to donate 50,000 doses to the Democratic Republic of the Congo and other neighboring regions.

The U.S. Food and Drug Administration has extended approval for Emergent BioSolutions' smallpox vaccine, ACAM2000, making it available for individuals at high risk of mpox infection, resulting in a 5% rise in the company's shares on Friday.

Announced late Thursday, the FDA's clearance positions ACAM2000 as the second U.S.-approved mpox vaccine after Bavarian Nordic's Jynneos. Emergent, with a market value around $471 million, predicts August sales of up to $490 million from stockpiled products like this vaccine and an anthrax shot.

However, the Emergent vaccine is unsuitable for those with weakened immune systems, including HIV-positive individuals. It gained limited traction during the 2022 U.S. mpox outbreak. Both Jynneos and ACAM2000 employ the vaccinia virus, similar yet less harmful than smallpox and mpox viruses.

Administered via small skin punctures with a two-pronged needle, ACAM2000 poses a risk of virus spread until the injection site heals. This approval coincides with the swift African spread of a new mpox strain, clade Ib. The WHO recently declared a global health emergency for the second time in two years.

Emergent aims to combat the current outbreak, offering to donate 50,000 doses to the Democratic Republic of the Congo and nearby nations. The company seeks WHO emergency listing for ACAM2000, with Japan's KM Biologics and Jynneos also awaiting listings.

Gaithersburg, Maryland-based Emergent's shares plunged last year due to manufacturing business challenges. However, a turnaround plan has boosted shares, which reached $9.24 in early trading, a significant recovery from their more than $130 pandemic peak.

(With inputs from agencies.)