Pharmaceutical Business review

US extends Imvamune smallpox vaccine trials

The contract extension will prolong the original contract to 2010 and has a value of $15 million, with the majority of revenue expected at the end of 2008 and beginning of 2009.

The US government is funding development for a safer smallpox vaccine that can be used in the case of a bioterrorism attack. However, a review by medical specialists investigating the risk to persons with atopic dermatitis for developing serious side effects from traditional smallpox vaccines, suggests that up to half of the US population could be at risk to the vaccine.

The most recent report of accidental exposure to the smallpox vaccine was the highly-publicized case of a two-year-old boy from Indiana with a history of eczema that developed a serious reaction after coming in contact with the vaccinia virus from his father’s smallpox vaccination.

Anders Hedegaard, president and CEO of Denmark-based Bavarian Nordic, said: “We are very pleased that the US government has decided to extend the ongoing RFP-2 contract to include clinical studies in people with atopic dermatitis, one of the largest risk groups for experiencing adverse reactions associated with traditional smallpox vaccines.

“This is an important step in our efforts to develop a safe next-generation smallpox vaccine for the entire population, and it builds further on our long-term partnership with the US Government.”