Emergent Biosolutions Inc. (NYSE: EBS) recently received approval from the U.S. Food and Drug Administration (FDA) for the expansion of the indication for its ACAM2000® vaccine to include the prevention of monkeypox (mpox) disease in individuals at high risk for infection. This follows the company's initial FDA approval in 2007 for active immunization for the prevention of smallpox disease in high-risk individuals.
The company's CEO, Joe Papa, emphasized the significance of this expanded indication, particularly in light of the current global health emergency due to the upsurge in mpox cases. The World Health Organization (WHO) has declared the recent increase in mpox cases a public health emergency of international concern, prompting Emergent Biosolutions to engage with global health leaders and file an expression of interest with the WHO for the emergency use listing of ACAM2000® in connection with the mpox outbreak.
As part of its response to the current mpox outbreak, Emergent Biosolutions announced a donation of 50,000 doses of ACAM2000® for potential deployment across impacted countries in central Africa.
Dr. Amesh A. Adalja, an expert in health security and emerging infectious diseases at Johns Hopkins Center for Health Security, highlighted the importance of leveraging ACAM2000® in combatting the uncontrolled mpox epidemic in Africa.
In 2022, a global outbreak of clade II mpox led to more than 95,000 cases across 115 non-endemic countries. The recently identified clade IB variant, known for enhanced transmissibility through close contact, has significantly impacted central Africa, particularly affecting children and families.
ACAM2000® is the primary smallpox vaccine designated for use in a bioterrorism emergency and is currently stockpiled in the U.S. and internationally. The vaccine is indicated for active immunization for the prevention of both smallpox and mpox disease in individuals at high risk for infection.
It's worth noting that the labeling for ACAM2000® contains a contraindication for individuals with severe immunodeficiency and includes warnings and precautions for various potential complications following vaccination.
This development underscores Emergent Biosolutions' commitment to addressing urgent public health threats and highlights the company's efforts in providing essential vaccines and therapeutics to protect and enhance global health. The market has reacted to these announcements by moving the company's shares 0.0% to a price of $8.91. Check out the company's full 8-K submission here.
