Emergent BioSolutions gains Singapore approval for ACAM2000 mpox indication

Emergent BioSolutions Inc. (NYSE: EBS) received approval from Singapore's Health Sciences Authority to expand the indication for its ACAM2000 vaccine to include prevention of mpox disease in adults at high risk for infection.

The expanded indication is supported by existing human safety data and data from an animal study demonstrating the vaccine's effectiveness against mpox virus exposure. ACAM2000 was originally approved by Singapore's HSA in 2009 for smallpox prevention.

The single-dose vaccine is administered percutaneously via a bifurcated needle. Under the expanded indication, ACAM2000 is approved for active immunization against mpox in adults determined to be at high risk during outbreaks associated with severe or life-threatening disease where alternative vaccines are unavailable or contraindicated.

The vaccine carries warnings for serious complications including myocarditis and pericarditis, which were observed at a rate of 5.7 per 1000 primary vaccinees. Other potential serious adverse events include encephalitis, progressive vaccinia, and severe skin infections.

Mpox is an infectious disease endemic to central and west Africa caused by a double-stranded DNA virus. The approval expands ACAM2000's authorized use in Singapore beyond its original smallpox indication.

Information is based on a company press release statement.

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