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Novavax Publishes First H1N1 Influenza VLP Vaccine Report

Novavax has published the first report of a vaccine protecting ferrets against the 2009 pandemic H1N1 virus in the journal Vaccine May 12, 2010 online issue. The scientific report is co-authored by scientists from Novavax and the Centers for Disease Control and Prevention (CDC), based in Atlanta, GA, under a collaborative agreement.

Novavax said that it has produced a 2009 H1N1 influenza VLP vaccine and delivered it to the CDC in less than four weeks following the April 24, 2009 announcement of the strain of the H1N1 influenza for vaccines.

Novavax claimed that CDC scientists immunised ferrets with 3.75, 7.5, or 15.0mcg dose of 2009 H1N1 influenza VLP vaccine or a placebo then boosted with a second dose after three weeks. The H1N1 influenza VLP vaccine was highly immunogenic and all vaccinated animals, even in the lowest 3.75mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, which is considered a protective level of immunity.

Reportedly, vaccinated animals were challenged with nasal exposure of live H1N1 influenza virus isolated. Three days post challenge, animals immunised with the 15mcg dose of the H1N1 influenza VLP vaccine had no detectable virus recovered in nasal washes and showed no signs of disease. In contrast, control animals that received no vaccine were not protected from virus replication and became ill.

Rahul Singhvi, president and CEO of Novavax, said: “This study demonstrated the ability of our influenza VLP technology to respond quickly with an effective vaccine in the face of an influenza pandemic. We are pleased with the publication of this important study.”

The published report concludes: “This study demonstrates that effective immunity to H1N1 pandemic virus can be achieved in ferrets by VLP vaccination, resulting in protection and viral clearance from the upper and lower respiratory tracts. Recombinant VLP vaccines are non-infectious and have advantages in safety and manufacturing.

“They circumvent problems like slow growth, unpredictable yields, and mutations during host adaption. Thus, rapid response immunisation strategy for pandemic influenza outbreaks could include the preparation of VLP vaccine for prevention of disease in people.”