Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Novavax has announced the execution of a contract modification to extend the base period of performance of its current contract with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Novavax' recombinant seasonal and pandemic influenza vaccines.
Subscribe to our email newsletter
The contract was originally awarded in February 2011, with funding of up to $97m over an initial base period ending in February 2014. Novavax and BARDA have agreed to amend the agreement to allow Novavax to continue to access the remainder of the $97m in base period funding through September 2014.
These funds will support the upcoming Phase II trial for our H7N9 vaccine candidate with Matrix-M, and activities relating to our quadrivalent seasonal influenza vaccine. BARDA has the ability to dedicate up to $79m in additional funds to support Novavax’ later-stage development of these vaccines, during an option period currently anticipated to add two years to the overall performance period.
Novavax CEO and president Stanley C Erck noted development of the company’s seasonal and pandemic influenza products during the last three years under our contract with BARDA has allowed it to refine and develop influenza vaccine products while delivering important clinical trial results from its seasonal quadrivalent, avian H5N1, and most recently, avian H7N9 studies.
"While our original development plans anticipated utilizing the full amount of the contracted base-period funding within the three-year period, certain scope changes and development efforts resulted in delayed development timelines. Extending the base period allows us to continue to access the remaining base period budget as we initiate a pandemic H7N9 Phase 2 study early this year and prepare for additional Phase 2 and Phase 3 influenza clinical trials, which we expect would occur during the contract’s option period," Erck added.
In February 2011, Novavax was awarded a contract valued at up to $179m by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness.
Throughout the contract’s base period, 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 is expected to be extended, upon execution by BARDA of an Option One period. 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 ($3m).