USA-based clinical-stage biopharmaceutical group Novavax (Nasdaq: NVAX) Novavax says that the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) has completed an in-process review (IPR) of the company’s contract covering the company's recombinant virus-like particle (VLP) vaccine candidates for pandemic and seasonal influenza.
The contractually-defined IPR was conducted by a team of US government experts (BARDA, FDA, NIH and CDC), who provided input on Novavax' progress during the contract base period and plans for further development, including both near-term process development and manufacturing activities and longer-term clinical efforts. BARDA has notified the company that based on the results of the IPR, a milestone decision has been made to continue the contract for both the seasonal and pandemic influenza programs.
In March 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant vaccines for the prevention of seasonal and pandemic influenza. In the midst of the contract's three-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness.
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