FDA approves ACAM2000 vaccine for protection against smallpox

Vaccine manufacturer Acambis has had its ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for protection against smallpox approved by the US FDA. ACAM2000 is the first biodefence vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.

Acambis developed ACAM2000 under contracts with the US Centers for Disease Control and Prevention (CDC). To date, the company has supplied 192.5 million doses of ACAM2000 to the CDC for the US Strategic National Stockpile (SNS), which was established to provide medicines to the American public in the event of a public health emergency, such as a terrorist attack.

Acambis and the CDC are now in advanced discussions on a "warm-base manufacturing" contract for Acambis to provide ACAM2000 production and licence maintenance activities for the long term.

ACAM2000 was developed to be a modern smallpox vaccine with a safety and efficacy profile comparable to the previous US vaccine but manufactured using advanced production capabilities.

"The licensure of ACAM2000 is a significant milestone not only for Acambis but also for the US Government in its efforts to ensure a state of preparedness against the threat of smallpox," said Ian Garland, Acambis ceo. "This has been a highly successful collaboration between Acambis and the CDC, and Acambis is very proud to have played a role in providing this countermeasure against a significant bioterrorism threat. We look forward to finalising an agreement with the CDC that will ensure that a US-based capability to manufacture ACAM2000 remains at the ready."