NIH Agrees To Evaluate Novavax’ Drug For H1n1 Strain

Novavax, and the Division of Microbiology and Infectious Diseases (DMID) have entered into an agreement to cooperate in the evaluation of a virus-like particle (VLP) vaccine candidate against the novel influenza A (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. The company 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.

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