FDA Approves Emergent Mpox Vaccine Amid Outbreak

Emergent BioSolutions has joined forces with Bavarian Nordic to combat the ongoing mpox crisis. The FDA recently expanded the use of Emergent's smallpox vaccine, ACAM2000, to prevent mpox infection in high-risk individuals.

ACAM2000’s approval for mpox follows the World Health Organization's declaration earlier this month that the current outbreak in the Democratic Republic of Congo and other parts of Africa constitutes a public health emergency of international concern. In response, Emergent announced a donation of 50,000 doses of ACAM2000 to the humanitarian organization Direct Relief. This organization will collaborate with local and regional health authorities to deliver the vaccine to hard-to-reach locations.

ACAM2000, a live vaccinia virus vaccine, contains non-active components that do not cause disease or transmission. It works by initiating a localized infection reaction at the injection site, which primes the immune system to fight against active infections. The vaccine also promotes the production of neutralizing antibodies and B and T cells, contributing to long-term immune memory.

The vaccine is administered through a single-dose percutaneous shot. A bifurcated needle is dipped into the vaccine solution and then pricks the skin several times in the upper arm. However, it has a boxed warning for serious complications such as myocarditis, pericarditis, encephalitis, encephalomyelitis, and other conditions that could lead to severe disability, permanent neurological damage, or death.

ACAM2000 initially received FDA approval in 2007 for smallpox prevention in high-risk individuals. In November 2023, Emergent filed a supplemental Biologics License Application to expand the vaccine's use to mpox, using previously available human safety data and findings from a controlled animal study.

With this recent approval, Emergent now joins Bavarian Nordic at the forefront of the pharmaceutical industry's efforts to combat the mpox outbreak. Bavarian Nordic, a Danish developer, recently announced increased production of its vaccine Jynneos, which also offers immune protection against both mpox and smallpox.

Bavarian Nordic has already received orders for 175,420 doses of Jynneos from the European Commission’s Health Emergency Preparedness and Response Authority, as well as an additional 440,000 doses from an unnamed European country. The company is capable of producing up to 2 million additional doses this year and plans to manufacture up to 10 million more by the end of 2025.

According to the U.S. Centers for Disease Control and Prevention, Jynneos appears to be a safer option compared to Emergent’s ACAM2000. The latter has been noted to have "more side effects and contraindications" than Bavarian Nordic's vaccine.

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