As mpox continues to circulate globally and smallpox remains a recognized bioterrorism concern, vaccine access is expanding into new international markets. Emergent BioSolutions announced on May 18, 2026, that Saudi Arabia’s Food and Drug Authority (SFDA) has approved ACAM2000 [Smallpox and Mpox (Vaccinia) Vaccine, Live] for the prevention of both smallpox and mpox in individuals determined to be at high risk for infection. The approval marks the first Emergent product to receive licensure from the SFDA.
The authorization follows a recent regulatory action in Singapore, where the Health Sciences Authority approved an expanded indication for ACAM2000 to include mpox prevention in high-risk adults. Together, the two approvals reflect a pattern of growing international uptake of biodefense countermeasures originally developed for government stockpiling programs.
ACAM2000 is a live vaccinia virus vaccine indicated for active immunization against smallpox and mpox. It carries significant safety considerations, including a boxed warning for serious adverse events such as myocarditis and pericarditis, observed in suspected cases at a rate of 5.7 per 1,000 primary vaccinees, as well as encephalitis, eczema vaccinatum, and the risk of fetal death. The vaccine is contraindicated in individuals with severe immunodeficiency. Given these risks, its use is restricted to populations determined to be at elevated risk of exposure.
Smallpox, eradicated in nature but preserved in authorized laboratories, is considered a credible bioterrorism threat due to its high mortality and the erosion of population-level immunity since routine vaccination ended in the early 1980s. Mpox, caused by a related orthopoxvirus, has generated more than 137,000 confirmed cases and over 300 deaths globally since the start of the 2022 outbreak. Expanding regulatory approval of cross-protective vaccines like ACAM2000 into the Gulf region extends the geographic reach of preparedness infrastructure for both naturally occurring outbreaks and potential deliberate use scenarios.
Emergent BioSolutions, headquartered in Gaithersburg, Maryland, focuses on developing and supplying medical countermeasures to governments for national security and public health preparedness purposes. Its portfolio addresses threats including smallpox, mpox, anthrax, botulism, and Ebola.
Source: Emergent BioSolutions Receives Saudi Food and Drug Authority Approval for ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live] – Emergent BioSolutions