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Novavax Presents Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program at World Health Organization Conference
Date:2/17/2009

es against the NA and M1 proteins.

"Strong HAI titers combined with a high yielding manufacturing process presents a promising approach to creating an unadjucanted H%N1 vaccine," said Rahul Singhvi, CEO. Although the safety data are still blinded, there have been no serious adverse events reported. An independent, external Data and Safety Monitoring Board reviewed the safety data early in the study, including data among subjects who had received two injections of the 90 mcg dose, and fully supported study continuation.

VLPs are recombinant structures that mimic the size and shape of the virus but lack genetic material and are therefore incapable of replication. Because they resemble actual infectious particles, presenting proteins in the same conformation as the wild-type virus, they are able to induce a potent immune response. The HA and NA are included to induce neutralizing antibody responses to prevent infection and spread of the virus down the respiratory tract into the lungs, whereas the M1 may induce cell-mediated immune responses that provide protection against drifted (i.e., mutated) strains.

Addressing the Gaps in the System

"These data, coupled with the strong neutralizing antibody titer data from this study disclosed last year, demonstrate that the Novavax recombinant VLP vaccine is a valid and potent approach against pandemic influenza. This vaccine and our innovative manufacturing approach have the potential to address an unmet need in pandemic influenza preparedness efforts being planned by health authorities around the world," said Dr. Rahul Singhvi, President and CEO of Novavax.

Novavax's manufacturing process makes it possible to potentially produce and distribute a vaccine matched to a pandemic strain in time to interrupt and/or halt a pandemic. Novavax's influenza VLPs are produced in insect cell culture, utilizing a manufacturing process that co
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SOURCE Novavax, Inc.
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