Acambis plc (Acambis), a leading vaccine company, announced that the US Food and Drug Administration (FDA) has approved its ACAM2000 (smallpox (vaccinia) vaccine, live) vaccine for active immunisation against smallpox disease for persons determined to be at high risk for smallpox infection. This approval is a key step towards Acambis finalising a long-term "warm-base manufacturing" contract with the US government.

Acambis developed ACAM2000 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 (SNS). To date, Acambis has supplied 192.5 million doses of ACAM2000 to the CDC for the SNS.

Acambis is currently in advanced negotiations with the CDC for a "warm-base manufacturing" contract to provide the US Government with a long-term ACAM2000 production capability that is located entirely in the US. The contract would also cover licence maintenance activities.

Ian Garland, Acambis' chief executive officer, said: "The licensure of ACAM2000 is a significant milestone not only for Acambis but also for the US Government in its plans to ensure a state of readiness against the threat of smallpox. This has been a highly successful collaboration between Acambis and the CDC, and we look forward to finalising the warm-base manufacturing contract to secure this vaccine production capability for the US Government for the long term."