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Novavax Reports Positive Data for its Trivalent Seasonal Influenza (VLP) Vaccine Candidate in a Second Phase II Study

Posted on 06 November 2009 - 16:30 by Alfie

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Story Summary: (Nasdaq: NVAX) a clinical-stage vaccine company, announced today that the Company made a poster presentation on the Safety and Immunogenicity of a Recombinant Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine in Healthy Adults on Saturday, October 31, 2009 at the 47(th) Annual Meeting of the Infectious Diseases Society of America (IDSA). This presentation included data from a study of Novavaxs trivalent seasonal influenza VLP vaccine that began in May of this year among healthy adults 18 to 49 years of age. For subjects in the 15 mcg group, seroprotection rates (95% CIs) were 67% (54,78), 91% (82,97), and 84% (73,92) against the H1N1, H3N2, and B strains, respectively. The seroconversion and seroprotection rates against this strain were 77% and 93%, respectively, among subjects in the 15 mcg group. Antibody responses were observationally compared among VLP vaccine and TIV recipients although the sample size for the TIV group was too small to support definitive conclusions. In this small study, HAI responses against the H1N1 and B strains were statistically indistinguishable and HAI responses against the H3N2 A/Brisbane strain appeared higher in VLP as compared with TIV recipients. In addition to the HAI responses, although not presented in the poster, functional antibody against the Neuraminidase enzyme was measured in the sera of immunized subjects using a neuraminidase inhibition assay (NAI) developed by Novavax scientists. Inhibition of neuraminidase activity may be important in reducing the spread of influenza virus down the respiratory tract and severe influenza disease. We believe that our VLP influenza vaccine has the potential to induce broad immunity against influenza including cross-reactivity against drifted strains which may emerge throughout an influenza season, said Dr. Singhvi. Seasonal InfluenzaGlobally, seasonal flu infects between 5 percent and 20 percent of the population and kills between 250,000 and 500,000 people each year. In the US, the Centers for Disease Control and Prevention reports that 15 to 60 million people contract influenza each year leading to over 200,000 hospitalizations and 36,000 deaths. The Advisory Committee on Immunization Practices (ACIP) currently recommends seasonal influenza vaccination for children six months through 18 years of age, pregnant women, and adults over 50 years of age, and individuals of any age with chronic health conditions or who are at high risk of influenza disease. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology. Further information on the factors and risks that could affect Novavaxs business, financial conditions and results of operations, is contained in Novavaxs filings with the U. S. Securities and Exchange Commission, which are available at www….Read the Full Story

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  1. NOVAVAX Announces Positive Results for the Second Phase II Clinical Trial of its Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine Candidate
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