FDA Approves Emergent's Smallpox Vaccine for Mpox Amid Africa Outbreak

As a new, deadly strain of mpox continues its global spread, Emergent BioSolutions' smallpox vaccine ACAM2000 has been officially approved by the FDA for use in preventing mpox in individuals considered at high risk. This marks a significant development in the fight against the virus.

Emergent BioSolutions, based in Maryland, has pledged 50,000 doses of its ACAM2000 vaccine to aid in combating the outbreak in Africa. The expanded use of ACAM2000 comes at a crucial time, as the global health community strives for an effective and coordinated response to the recent surge in mpox cases.

Emergent CEO Joe Papa highlighted the company's readiness to support this global effort by collaborating with health leaders and deploying available inventory as needed, with the capacity to increase supply if required. Originally approved in 2007 for smallpox prevention, ACAM2000’s new indication for mpox is backed by an animal study and existing human safety data.

Mpox, a zoonotic disease transmitted from animals to humans, is spreading rapidly due to the newly identified clade Ib variant. According to the Africa Centres for Disease Control and Prevention, the outbreak has affected 12 African countries, resulting in over 2,000 confirmed cases and 517 deaths. In response, the World Health Organization (WHO) has declared the situation a public health emergency.

To address the outbreak, Emergent has partnered with the U.S. government and WHO to donate 50,000 doses of ACAM2000 through Direct Relief to affected countries, including the Democratic Republic of Congo, Burundi, Kenya, Rwanda, and Uganda.

African health officials are calling for a global response to tackle the outbreak. They have also collaborated with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) and Bavarian Nordic to acquire and distribute over 215,000 doses of Bavarian Nordic’s mpox vaccine, Jynneos. Previously, Jynneos was the sole FDA-approved vaccine for mpox, and Bavarian Nordic has been striving to meet supply demands from multiple governments and public health organizations. Jynneos played a significant role in curbing mpox outbreaks in 2022 and 2023, and the company aims to provide 2 million doses this year and 8 million by 2025.

In addition to Emergent and Bavarian Nordic, SIGA Technologies, a smallpox drugmaker, has also joined the effort against mpox. However, SIGA’s smallpox antiviral recently failed to reduce the time to lesion resolution in a clinical trial within a 28-day treatment period. Despite this setback, the company remains optimistic, noting improvements in certain patient groups. SIGA secured supply contracts with the U.S. government and the Association of Southeast Asian Nations this summer.

These collective efforts from biotech companies and health organizations are vital in addressing the mpox outbreak, which poses a significant threat to global health. With the combined use of vaccines like ACAM2000 and Jynneos, along with ongoing research and international cooperation, there is hope for controlling the spread of this emergent virus.