Shares of Novavax, Inc. (NVAX) were flying Thursday after the company and the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) signed an agreement (.pdf) to cooperate in the evaluation of a virus-like particle (VLP) vaccine candidate against the novel influenza A (H1N1) virus.
Novavax has produced influenza A (H1N1) VLP vaccine against the strain recommended by the Centers for Disease Control and Prevention (CDC).
Novavax was highlighted in our (05/25/09) report: Which Small Biotech Firms Could Reap Benefits From Government's Flu Vaccine Initiative?
Novavax scientists produced the first batch of H1N1 VLPs within the company’s laboratories in May, just three weeks after the CDC announced the genetic sequence of a novel influenza A (H1N1) virus. This strain of influenza was isolated from an infected person located in California. These VLPs contain the hemagglutinin (HA), neuraminidase (NA) and matrix 1 (M1) proteins found in the newly emerged H1N1 influenza 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. Novavax has made purified influenza A (H1N1) VLPs, which are being sent to scientists at the CDC and DMID for studies in animal models.
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. This ability to respond rapidly is an important factor in the evaluation of alternative investigational vaccines against this emerging threat to public health.
The influenza A (H1N1) virus was first detected in April 2009, in Mexico, the United States and Canada and has subsequently spread rapidly to over sixty countries worldwide. A new report from Bloomberg says the Swine Flu ‘Overwhelmed’ U.S. Health-Care System.
Novavax has completed genetic engineering and manufacturing of the master seed stock necessary to produce larger quantities of the investigational influenza A (H1N1) VLP vaccine under cGMP conditions in its manufacturing facility in Rockville, MD.
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