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Novavax Announces Top Line Results of Phase IIa Clinical Trial for Its Seasonal Influenza VLP (Trivalent) Vaccine Candidate
Date:12/11/2008

mic the size and shape of a virus but lack genetic material and are therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to induce potent immune response. Novavax's VLP vaccine may be differentiated from other influenza vaccines in several ways. First, it includes three viral proteins important for inducing a broad immune response including two surface proteins, hemmaglutinin ("HA") and neuraminidase ("NA"), and a core matrix protein, M1. In contrast, most seasonal vaccines consist almost entirely of HA with little or no NA and M1. The HA protein induces antibody that neutralizes or blocks the growth of the virus; NA induces antibodies 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.

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 wi
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SOURCE Novavax, Inc.
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