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Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program
Date:8/26/2008

he safety data are still blinded pending complete safety follow-up, there have been no serious adverse events reported. An independent external Data and Safety Monitoring Board fully supported continuation of the study including expansion to the 90 mcg dose.

VLPs are recombinant structures mimicking 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 on the wild-type virus, they are able to induce a potent immune response. The HA and NA are included to induce neutralizing antibody responses, 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 are exciting because they demonstrate that recombinant VLPs are a valid and potent vaccine approach against influenza. Combined with our innovative manufacturing approach, our VLP vaccine candidate has 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 consists entirely of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than that of traditional egg-based or mammalian cell culture manufacturing. Because the Novavax process involves recombinant technology and does not require a live influenza virus, vaccine can be manufactured within 10 to 12 weeks of identification of a pandemic strain, approximately 50% of the time duration required to manufacture egg-based vaccines. As a key commercialization initiative, Nov
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SOURCE Novavax, Inc.
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