Novavax, Inc., a clinical-stage vaccine company, is finalizing details on costs and timelines for their next round of clinical studies with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) following successful completion of process improvement studies. Novavax is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under US INDs.
The pandemic study will include the use of Novavax’ proprietary saponinbased adjuvant, Matrix-M.
“Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal,” said Stanley C Erck, president and chief executive officer, “Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA’s interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine programme.”
In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract’s three-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA’s commitment to advancing recombinant-based technology as a component of pandemic preparedness. Upon satisfaction of established milestones, the contract can expect to be extended for an additional 24 months, upon execution by BARDA of an Option One period, valued at $79 million in additional funding. The milestones under the Option One period would focus on completion of the pathway to product licensures from the US Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million).
Novavax, Inc. is creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide.