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news.The FDA has approved Acambis's smallpox vaccine for persons determined to be at high risk for smallpox infection.
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The drug, known as 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, Acambis 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.
Having produced a stockpile of ACAM2000 doses for the SNS, 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. Until the development of ACAM2000, smallpox vaccines were last manufactured in the US in 1982 and were produced from calf lymph.