As a new deadly strain of mpox continues its global spread, Emergent BioSoultion's smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus.
The FDA signed off on the vaccine’s use as an mpox disease preventive in those deemed to be at a high risk for infection.
“This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases,” Emergent CEO Joe Papa said in a company press release. “We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.”
ACAM2000’s mpox nod, which follows its original 2007 approval for protection against smallpox, was supported by an animal study and “previously available” human safety data.
Mpox is a zoonotic disease that can be spread from animals to humans. Emergent’s vaccine option is administered by a needle dipped in the vaccine solution and pricked into the upper arm several times to deliver a droplet of the vaccine.
With a recently identified mpox strain called the clade Ib variant leading to viral spread across Africa, the World Health Organization (WHO) has declared the ongoing outbreak a public health emergency. So far, the virus has spread to 12 African countries and stacked up a count of more than 2,000 confirmed cases and 517 deaths, according to the Africa Centres for Disease Control and Prevention.
Emergent last week linked up with the U.S. government and the World Health Organization (WHO) to donate 50,000 doses of ACAM2000 to the impacted countries the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda through relief organization Direct Relief.
Meanwhile, African health officials are calling for a global response to address the outbreak and have partnered with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) and Bavarian Nordic to collect and distribute over 215,000 doses of Bavarian Nordic’s mpox vaccine, Jynneos.
Until now, Jynneos was the only FDA-approved mpox vaccine, leaving Bavarian Nordic racing to fulfill several supply contracts from various governments and public health agencies. That vaccine helped to curb previous mpox outbreaks in 2022 and 2023. The company looks to supply 2 million doses this year and 8 million in 2025 to help to further contain the virus.
Besides Emergent and Bavarian Nordic, smallpox drugmaker SIGA Technologies has joined in the fight against mpox, as well. SIGA’s smallpox antiviral, however, recently missed the mark in a trial, failing to reduce patients’ time to lesion resolution within a 28-day treatment period.
Still, the company said it was encouraged by the results, which showed a meaningful improvement in certain patient groups. SIGA locked down supply contracts this summer with the U.S. government and the Association of Southwest Asian Nations.