Emergent BioSolutions (NYSE:EBS), a global biodefense company, today announced that the Saudi Food and Drug Authority (SFDA) has approved the registration of ACAM2000® [Smallpox and Mpox  (Vaccinia) Vaccine, Live], for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection. This follows Emergent's recent announcement that Singapore's Health Sciences Authority (HSA) has approved an expanded indication for ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live] to include prevention of mpox disease in adults determined to be at high risk for mpox infection.

"We are pleased to receive this approval for ACAM2000® from SFDA for immunization against smallpox and mpox in high-risk individuals," said Simon Lowry, chief medical officer of Emergent. "ACAM2000® is the first Emergent product to be licensed by the SFDA and demonstrates the company's intent to collaborate with governments in the Gulf region and around the world as awareness and adoption of biodefense preparedness strategies continues to increase around the world."

Smallpox is considered a credible bioterror threat by experts, and its mortality makes it a potential high-impact threat with health, economic and national security implications.1 Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Since the start of the global outbreak of mpox in 2022, there have been more than 137,000 confirmed cases and more than 300 deaths reported globally.2

Emergent specializes in developing, manufacturing and delivering medical countermeasures to governments around the world for national security and health preparedness. These products support how governments respond to emergencies and help protect the public from potential threats like smallpox, mpox, anthrax and botulism.

Indication and Select Important Safety Information for ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live]

Indication

ACAM2000® is indicated for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection.