Report of 2009 H1N1 influenza VLP vaccine published online

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

Novavax produced a 2009 H1N1 influenza VLP vaccine and delivered it to the CDC in less than four (4) weeks following the April 24, 2009 announcement of the strain of the H1N1 influenza for vaccines.  CDC scientists immunized ferrets with 3.75, 7.5, or 15.0 mcg dose of 2009 H1N1 influenza VLP vaccine or a placebo then boosted with a second dose after three (3) weeks. The H1N1 influenza VLP vaccine was highly immunogenic and all vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, which is considered a protective level of immunity. Vaccinated animals were challenged with nasal exposure of live H1N1 influenza virus isolated. Three (3) days post challenge, animals immunized with the 15 mcg 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.

Dr. Rahul Singhvi, President and CEO of Novavax, stated: "This study demonstrated in real time 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 significant 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 immunization strategy for pandemic influenza outbreaks could include the preparation of VLP vaccine for prevention of disease in people."