FDA Approves ACAM2000 Vaccine for Mpox

Emergent BioSolutions has obtained approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application for ACAM2000, expanding its application to include the prevention of Mpox. The single-dose vaccine, administered using a bifurcated needle percutaneously, is now indicated for individuals at high risk of Mpox infection.

The FDA's approval of ACAM2000 for Mpox is grounded in existing human safety data and a thorough animal study that confirmed its efficacy. Originally, ACAM2000 was licensed in 2007 for active immunization against smallpox.

Mpox, previously called monkeypox, is a viral disease primarily found in Central and West Africa. The virus belongs to the Orthopoxvirus genus within the Poxviridae family, closely related to the smallpox virus, which was eradicated in 1980.

This recent FDA approval aligns with Emergent BioSolutions' ongoing efforts to enhance global health initiatives. The company has submitted an Expression of Interest to the World Health Organization (WHO) for emergency use assessment. In response to the WHO's declaration of the Mpox outbreak as a public health emergency of international concern, Emergent is actively collaborating with global health regulators. Additionally, the company has committed to donating 50,000 doses of ACAM2000 to support affected regions in Central Africa.

ACAM2000 serves as the primary smallpox vaccine in the event of a bioterrorism emergency and is a vital part of the US Strategic National Stockpile. The vaccine is also licensed in Canada, Australia, and Singapore, with stockpiles maintained both domestically and internationally. This ensures preparedness against potential bioterrorism threats and disease outbreaks.

Joe Papa, the president and CEO of Emergent BioSolutions, remarked, "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 for ACAM2000 comes at a crucial time as the global health community unites to ensure an effective and cohesive response to the recent surge in Mpox cases."

Recently, Emergent BioSolutions finalized the sale of its Baltimore-Camden manufacturing site to the Taiwanese company Bora Pharmaceuticals, reflecting the company's ongoing strategic adjustments.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!