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www.fdanews.com/articles/63567-cdc-to-test-novavax-s-h5n1-vaccine-candidate

CDC TO TEST NOVAVAX'S H5N1 VACCINE CANDIDATE

October 31, 2006

Novavax announced that the Centers for Disease Control and Prevention (CDC) has agreed to evaluate the company's H5N1 pandemic influenza vaccine candidate, including preclinical testing of the vaccine against live bird flu virus.

Under terms of a Cooperative Research Agreement, Novavax will provide the CDC with a supply of the company's virus-like particle (VLP) H5N1 vaccine. Over the past year, Novavax has assembled a significant dossier of preclinical data supporting its vaccine, which will serve as the basis for the company's investigational new drug application to the FDA. Novavax is planning to begin human clinical trials using the vaccine during the first half of 2007.

Last year, Novavax began collaborating with the CDC to evaluate a vaccine to protect against the H9N2, another subtype of bird flu.

VLPs are nearly identical to a virus but do not have the virus's genetic material required for replication or infection. When inoculated into the body, these particles have the ability to attach to cells and trigger a natural immune response that is capable of protecting against viral infection.