FDA Approves Second-Generation Smallpox Vaccine From Acambis

The US Food and Drug Administration (FDA) has approved the ACAM2000 vaccine made by Acambis (Cambridge, UK, www.acambis.com), for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. This approval is a key step towards Acambis’ finalizing a long-term manufacturing contract with the US Government. Acambis developed the vaccine under contracts with the US Centers for Disease Control and Prevention (CDC) as part of its preparations for a public health emergency. ACAM2000, which is a single-dose vaccine, is the primary smallpox vaccine for use in an emergency and forms the majority of the US Government's smallpox vaccine Strategic National Stockpile. Acambis has supplied 192.5 million doses of ACAM2000 to the CDC for the stockpile.