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Novavax Completes Enrollment of Its Seasonal Influenza VLP Vaccine Phase IIa Clinical Trial
Date:9/19/2008

that prevent cell-to-cell transmission of virus down the respiratory tract, potentially reducing the severity of influenza disease; and cell mediated immune responses to M1 may lead to destruction of cells already infected. Further, the vaccine is made in cell culture rather than eggs, which permits an exact genetic match to the flu strains causing illness since there is no requirement for adapting the vaccine to grow in eggs.

"We are pleased to complete enrollment so quickly of our seasonal influenza vaccine Phase IIa trial", said Dr. Rahul Singhvi, President and CEO of Novavax. "The completion of enrollment for this critical clinical trial within a week of its initiation should enable us to release top line data from this study in the fourth quarter of this year. I congratulate our team on this accomplishment and for advancing two novel influenza vaccines into Phase II development this year."

Novavax's novel manufacturing approach

Novavax's manufacturing process makes it possible to rapidly produce a vaccine that contains strains that are an exact genetic match to the strains circulating in the community causing influenza disease. Novavax's influenza VLPs are produced through recombinant technology in insect cell culture, utilizing a manufacturing process that will consist entirely of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than those of traditional egg-based or mammalian cell culture manufacturing. Because the Novavax process involves recombinant technology and does not require a live influenza virus, a matched vaccine for the first seasonal influenza clinical trial was manufactured within 12 weeks of identification of the Centers for Disease Control and Prevention ("CDC") released seasonal strains, or approximately half the time required to manufacture egg-based vaccines. The ability to rapidly respond to the identification of annual seasonal strains may be important in providing timely vaccine in advance
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SOURCE Novavax, Inc.
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