Emergent BioSolutions’ ACAM2000 receives FDA approval for Mpox prevention

Emergent BioSolutions Inc. (NYSE: EBS) has achieved a notable milestone with the U.S. Food and Drug Administration (FDA) approving the supplemental Biologics License Application (sBLA) for ACAM2000. The approval expands the vaccine’s indication to include the prevention of mpox, a development that comes at a critical juncture as mpox continues to spread globally, particularly across Africa and other regions.

The FDA’s decision is based on robust data, including existing human safety records and a well-controlled animal study. This study demonstrated ACAM2000’s effectiveness in protecting against mpox virus exposure. ACAM2000 is administered as a single dose using a bifurcated needle dipped in the vaccine solution, which is then used to prick the skin multiple times in the upper arm.

Originally approved in 2007 for the prevention of smallpox, ACAM2000 now addresses mpox, an infectious disease endemic to Central and West Africa. Mpox, previously known as monkeypox, is caused by the double-stranded DNA mpox virus, a member of the Orthopoxvirus genus within the Poxviridae family. This virus is closely related to the one that caused smallpox, which was eradicated in 1980 through a global vaccination campaign.

Joe Papa, President and CEO of Emergent BioSolutions, highlighted the significance of this approval: “The FDA approval of ACAM2000 for immunization against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV and TEMBEXA. This expanded indication comes at a crucial time as the global health community unites to tackle the recent rise in mpox cases. We are ready to support the global response by deploying available inventory and increasing supply as required.”

This approval is timely given the recent surge in mpox cases. Emergent BioSolutions has proactively filed an Expression of Interest (EOI) with the World Health Organization (WHO) for ACAM2000 to be included in the WHO’s Emergency Use Listing. In addition, the company is engaged in discussions with global public health leaders and has committed to donating 50,000 doses of ACAM2000 for potential deployment in Central Africa.

Dr. Amesh A. Adalja, FIDSA, FACP, FACEP, and a health security expert at Johns Hopkins Center for Health Security, commented on the broader context of the approval: “Mpox has progressed to an uncontrolled epidemic in Africa, prompting the WHO to declare a second public health emergency of international concern. The expanded use of ACAM2000, a direct descendant of the Jenner vaccine that eradicated smallpox, will be a critical tool in combating this threat.”

The global health community is grappling with the escalating mpox situation. In 2022, a major outbreak of clade II mpox resulted in over 95,000 cases across 115 non-endemic countries. This clade is known for causing more severe clinical symptoms compared to other variants. The outbreak has placed immense pressure on public health systems worldwide and highlighted the need for effective vaccination strategies.

Emergent BioSolutions’ strategic move to expand ACAM2000’s indication underscores the company’s commitment to addressing urgent public health threats and enhancing global preparedness for infectious disease outbreaks.