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NOVAVAX Announces Positive Results for the Second Phase II Clinical Trial of its Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine Candidate
Date:9/1/2009

4-fold or higher rise in HAI titer from baseline) ranged from 81-86% for H3N2, 57-66% for H1N1, and 62-67% for B for subjects with and without existing antibody before vaccination. As seen in Novavax's previous seasonal flu vaccine study, robust HAI responses were also observed against drifted H3N2 strains, demonstrating the potential for VLP vaccines to be cross-protective against flu viruses from different seasons without the addition of an adjuvant.

One of the main advantages of Novavax's recombinant, cell culture based VLP technology is that it results in VLPs that are a genetic match to the flu strains of interest. It does not require live flu virus seed that has to be adapted to grow in eggs to create the egg-based vaccine. This attribute of recombinant VLPs may lead to a more efficacious vaccine against the flu strains that are circulating in the community. The results of this study provided Novavax's first human data to support this hypothesis. The H3N2 strain that was circulating during the 2008-2009 season did not grow well in eggs; therefore, an adapted or "substitute" strain had to be used to make the egg-based influenza vaccines, including Fluzone(R), the same egg-based vaccine used in this study. Recipients of Novavax's VLP vaccine had higher antibody responses against the H3N2 virus that was circulating in the community than recipients of Fluzone(R). The number of subjects that were studied was too small to draw definitive conclusions, but the results strongly support moving forward with larger head-to-head trials of the VLP and egg-based vaccines, the first of which is scheduled to start this Fall in elderly adults.

"The safety and immunogenicity results from this study give us confidence to move our seasonal influenza VLP vaccine candidate forward into late phase development," said Dr. Penny Heaton, Chief Medical Officer and Vice President of Development of Novavax. "Given the immunogenicity results we s
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SOURCE Novavax, Inc.
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