Emergent BioSolutions Expands Smallpox Vaccine Approval to Combat Mpox After Restructuring and Facility Closures
September 4, 2024
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Emergent BioSolutions has received expanded approval from the U.S. Food and Drug Administration (FDA) for its smallpox vaccine, ACAM2000, now including protection against mpox (formerly known as monkeypox) for individuals at high risk of infection. This significant development comes as part of a broader effort to address the recent resurgence of mpox cases, particularly in Africa.
The FDA’s decision, announced late Thursday, reflects a concerted global response to the ongoing mpox outbreak, which has led to a renewed public health emergency. Emergent BioSolutions, headquartered in Gaithersburg, Maryland, has been producing ACAM2000 for the U.S. Strategic National Stockpile since 2007, initially approved for smallpox. The vaccine’s expanded use now includes mpox, a related orthopoxvirus.
“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,” said Joe Papa, Emergent’s president and CEO. “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.”
The FDA’s approval was based on existing human safety data and additional animal studies demonstrating the vaccine’s efficacy against mpox. However, ACAM2000 cannot be used in individuals with compromised immune systems, including those with HIV. The vaccine, which uses a live form of the vaccinia virus, is administered via a series of small pokes on the skin, which can potentially spread the live virus to other parts of the body or to other individuals until it heals.
In response to the surge in mpox cases, Emergent BioSolutions plans to donate 50,000 doses of ACAM2000 to countries in Central Africa, where the outbreak has been severe. The company also stated that it has additional doses in inventory and has the capacity to ramp up production to approximately 40 million doses if necessary.
The approval of ACAM2000 adds to the existing arsenal of mpox vaccines in the U.S., joining Bavarian Nordic’s Jynneos. The emergence of a new mpox strain, clade Ib, has intensified the global response to the outbreak, leading the World Health Organization (WHO) to declare mpox a global public health emergency for the second time this year due to its rapid spread.
However, it is important to note that the vaccine will not be produced in Baltimore, where Emergent previously had a significant manufacturing presence.
In May, Emergent announced the closure of its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility as part of a broader restructuring plan. In June, the company finalized the sale of its Baltimore-Camden drug product facility to Bora Pharmaceuticals, marking the end of a challenging period for its manufacturing operations.
Emergent’s stock saw a significant rise following the announcement but faced volatility as the WHO reviews emergency licenses for other vaccines. The company’s shares have experienced fluctuations, reflecting broader challenges and adjustments within its business.
In recent years, Emergent faced setbacks, including issues with its contract manufacturing business and a major controversy involving COVID-19 vaccine production. The company had to discard approximately 525 million doses of bulk vaccine and faced legal and financial repercussions. Emergent has since pivoted away from its troubled manufacturing segment and is now focusing on supporting global health needs through its expanded vaccine portfolio.
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