November 8, 2006

The Centers for Disease Control and Prevention (CDC) will evaluate Novavax's pandemic influenza vaccine, including conducting preclinical tests on a live strain of H5N1 bird flu virus, the company said.

Novavax will give the CDC a supply of its virus-like particle (VLP) H5N1 vaccine for testing according to the terms of a cooperative research agreement. Human clinical trials for the H5N1 vaccine should start in the first half of 2007, Novavax said Oct. 31.

Novavax said it will submit an investigational new drug application to the FDA featuring preclinical data the company has accumulated over the past year.

VLPs lack a virus' genetic material, but otherwise are nearly identical to the virus. When inside the body, the VLP's can prompt an immune system response that protects against viral infection. VLPs have a shorter production lead time than traditional vaccines, which is essential to the preparation for a possible influenza pandemic, Terrence Tumpey, senior microbiologist at the CDC, said.

Last year, the CDC began evaluating another Novavax vaccine, intended to protect against the H9N2 subtype of bird flu.