ROCKVILLE, Md., Nov. 2 /PRNewswire-FirstCall/ -- Novavax, Inc. 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).
The trivalent seasonal influenza VLP vaccine was well tolerated and immunogenic. The incidence of adverse events was comparable in the VLP vaccine groups (10.6%) and the placebo group (11.8%). No serious vaccine-related adverse events have been reported to date. The VLP vaccine induced robust hemagglutination inhibition (HAI) antibody responses against all three strains in the vaccine and a drifted strain. Seroconversion (greater than or equal to 4-fold rise in titer from baseline) rates met the suggested FDA criteria for licensure of seasonal influenza vaccines for all three strains. For subjects in the 15 mcg group, seroconversion rates (95% CIs) were 57% (44, 68), 86% (75,93), and 62% (50,74) against the H1N1, H3N2, and B strains, respectively. Seroprotection (titer greater than or equal to 1:40) rates met the FDA criteria for licensure for all strains except the H1N1 strain. 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. Interestingly, the FDA seroconversion and seroprotection criteria were also met for a drifted H3N2 strain, A/Wisconsin/67/05, which was included in the 2006-2007 influenza vaccine. The seroconversion and seroprotection rates against this strain were 77% and 93%, respectively, among subjects in the 15 mcg group.
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. Preliminary data indicate that the trivalent seasonal influenza VLP vaccine induced functional antibody that inhibits neuraminidase activity of Types A and B influenza viruses.
Seasonal Influenza
Globally, 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 $2.8 billion in 2007 to $6.5 billion by 2013.
About Novavax
Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based, recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. It recently launched a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.
CONTACT: Tricia J. Richardson of Novavax, Inc., +1-240-268-2031
Web site: http://www.novavax.com/
