Novavax has received notification from the US Department of Health and Human Services that its proposed recombinant influenza vaccine is being considered as part of the country's pandemic preparations.
The Biomedical Advanced Research and Development Authority (BARDA) has determined that the company's recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness are in the competitive range for the award of an advanced development contract.
Novavax submitted its proposal in September 2009 in response to government requests to develop a new influenza vaccine in a US-based manufacturing facility.
BARDA has proposed to conduct a pre-award site visit to inspect Novavax's manufacturing facility in Rockville, Maryland.
CEO and president of Novavax, Rahul Singhvi, said the company has made significant progress in the development of their recombinant virus-like particle (VLP) vaccine candidates for both seasonal and pandemic influenza (H5N1 and H1N1).
"We have now vaccinated over 4,200 subjects, demonstrating both safety and immunogenicity of our vaccine candidates," Singhvi said.