The Department of Health and Human Services (HHS) has supported the initiation of an expanded Phase 3 study of the IMVAMUNE smallpox vaccine produced by Bavarian Nordic A/S. The U.S. government contract under Project BioShield calls for 20 million doses of IMVAMUNE for a potential smallpox outbreak emergency. This expanded Phase 3 study increases the contract value by $32 million to a total of $544 million.
“This additional $32 million from the Department of Health and Human Services will allow Bavarian Nordic to move forward with our Phase 3 trial of IMVAMUNE smallpox vaccine,” said Anders Hedegaard, President and CEO of Bavarian Nordic A/S. “This study will greatly expand our already promising database and further demonstrate the safety of this important bioterrorism medical countermeasure.”
The Phase 3 trial will include 4,000 subjects with an enrollment expected in the first half of 2013, and could support a Biologics License Application (BLA) submission to the FDA. Bavarian Nordic has also submitted marketing applications in Europe and Canada. The company requested the modification of the existing contract to cover costs associated with the larger design of the study than was initially contracted for.
Bavarian Nordic has already delivered more than 8 million doses of IMVAMUNE to the Strategic National Stockpile. Delivery of the remainder of the 20 million doses is expected in 2012 and 2013.