Acambis developed ACAM2000 under contracts with the US Centers for Disease Control and Prevention in response to the US government’s need for a stockpile of smallpox vaccine to counter the threat of smallpox being used as a biological weapon. The UK biotech does not intend to market the drug in the US outside of sales to the US government.
The advisory committee said that the vaccine had achieved an effective immune response in both those naïve to vaccination and those who had been vaccinated against smallpox before, two of the main study goals. The report from the committee also recommended a black box warning relating to serious adverse events from the study.
To date, Acambis has supplied 192.5 million doses of ACAM2000 to the US’s Strategic National Stockpile under an FDA investigational new drug application.