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GEN News Highlights : Jun 4, 2009

NIH to Evaluate Novavax Vaccine Candidate for Novel H1N1 Strain

Company says vaccines are currently being sent to CDC and DMID scientists for animal studies.

NIH's Division of Microbiology and Infectious Diseases (DMID) will cooperate with Novavax to evaluate the company's virus-like particle vaccine candidate for influenza A, or the H1N1 virus. Novavax has produced an influenza A (H1N1) VLP vaccine against the strain recommended by the CDC.

The company produced the first batch of H1N1 VLPs in its laboratories in May, three weeks after the CDC announced the genetic sequence of the novel H1N1 virus, which was isolated from an infected person located in California. Novavax' VLPs contain hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins, which were found in this strain.

The size and structure of the VLPs are nearly identical to those of the novel H1N1 virus, but the VLPs are not infectious, as they lack the genes necessary for replication, the company explains. Novavax has made purified influenza A VLPs, which are being sent to scientists at the CDC and DMID for studies in animal models. Novavax has also completed genetic engineering and manufacture of the master seed stock necessary to produce larger quantities of the investigational H1N1 VLP vaccine under cGMP conditions in its manufacturing facility in Rockville, MD.ADNFCR-2184-ID-19202905-ADNFCR

"The company has committed necessary resources to respond as rapidly as possible to construct and manufacture VLP vaccine against this new H1N1 influenza virus," says Rahul Singhvi, president and CEO of Novavax. "Our proprietary recombinant cell culture technology has enabled production of custom VLPs against this strain of influenza within weeks."