Emergent BioSolutions Inc (NYSE: EBS) received approval from the Saudi Food and Drug Authority for its ACAM2000 vaccine to prevent smallpox and mpox in high-risk individuals, according to a company statement.

The approval covers the smallpox and mpox vaccinia vaccine for people determined to be at high risk for infection from either disease. This marks the first Emergent product licensed by the Saudi regulatory authority.

The approval follows Singapore's Health Sciences Authority expanding ACAM2000's indication to include mpox prevention in high-risk adults. Emergent develops medical countermeasures for governments worldwide focused on biodefense preparedness.

The vaccine carries warnings for serious complications including myocarditis and pericarditis, observed in 5.7 per 1,000 primary vaccinees. Other potential adverse effects include encephalitis, progressive vaccinia, severe skin infections, and fetal death.

ACAM2000 is contraindicated for individuals with severe immunodeficiency, including those undergoing bone marrow transplantation or with primary or acquired immunodeficiency states requiring isolation.

Since 2022, the global mpox outbreak has resulted in more than 137,000 confirmed cases and over 300 deaths worldwide, according to the company statement. Mpox virus belongs to the same family as variola virus, which causes smallpox.

Smallpox is considered a potential bioterrorism threat by experts due to its high mortality rate and potential health, economic and national security implications.