RegulatoryMay 18, 2026, 09:01 AM
Emergent BioSolutions' ACAM2000® Approved by SFDA for Smallpox, Mpox
AI Summary
Emergent BioSolutions announced that the Saudi Food and Drug Authority (SFDA) has approved ACAM2000® vaccine for the prevention of smallpox and mpox in high-risk individuals. This marks the first Emergent product licensed by the SFDA, signaling the company's intent to expand collaborations in the Gulf region. The approval follows a recent expanded indication approval by Singapore's Health Sciences Authority for ACAM2000® to include mpox prevention. The vaccine addresses global health threats, with over 137,000 mpox cases and 300 deaths reported globally since 2022.
Key Highlights
- Saudi Food and Drug Authority (SFDA) approved ACAM2000® vaccine for smallpox and mpox prevention.
- ACAM2000® is the first Emergent product to be licensed by the SFDA.
- Singapore's Health Sciences Authority (HSA) recently approved ACAM2000® for mpox prevention.
- Global mpox outbreak since 2022 has seen over 137,000 confirmed cases.
- Over 300 deaths from mpox have been reported globally since 2022.
- Emergent aims to collaborate with governments in the Gulf region and worldwide.
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