Denmark's Bavarian Nordic is reporting a favorable safety profile for its smallpox vaccine Imvamune. As part of a Phase II trial, Imvamune was administered to 300 HIV positive subjects as well as 86 healthy subjects to test the vaccine's safety in those with a weak immune system. "[T]here was no difference in adverse events between the healthy and HIV infected subjects, even in the most immune compromised patients," the company said in a statement. Imvamune has been tested in more than 2,200 people in 11 completed or on-going clinical studies.
Within the next few days the safety report of this study will be submitted to the FDA and this will trigger a $25 million milestone payment under the RFP-3 contract. In June 2007 Bavarian Nordic won a $1.6 billion HHS contract to manufacture and deliver a next-generation smallpox vaccine designed to be safer than currently stockpiled smallpox vaccines. Full results from the Phase II are expected in the second half of 2009.
- see Bavarian Nordic's release