Novavax Presents RSV F Protein Nanoparticle Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26
Dr. Glenn's presentation titled: Immunogenicity of the RSV nanoparticle vaccine in humans and the induction of palivizumab competing antibodies, highlights new data from the company's first Phase 2 clinical trial in 330 women of childbearing age. In all participants (including placebo recipients), sera were evaluated using Western Blot for evidence of new infection at day 0, 56 and 115. All vaccinations were complete by day 56 and from day 56 to 112, subjects passed through what approximates an RSV season, December to March. During this period, 20% of the placebo recipients had evidence of a new RSV infection compared to only 10% of the immunized participants, representing a 50% reduction in infection rates. Prevention of RSV infection in women of childbearing age suggests that the vaccine, which is expected to provide benefit to newborns, pediatrics and elderly, could also benefit pregnant women. The potential to protect pregnant women from RSV infection would be consistent with recommendations to vaccinate pregnant women against seasonal influenza and provide additional benefit to a maternal immunization program.
"Prevention of infection is a high bar relative to preventing respiratory disease. The data presented today suggest that our RSV F vaccine reduced the incidence of RSV infection by 50%. These findings are in line with preclinical cotton rat studies showing that the RSV F vaccine was effective in preventing both lung disease and nasal infection in challenge studies, which were recently published in the Journal Vaccine," said
RSV is a widespread disease that causes infections of the lower respiratory tract. While RSV affects individuals of all ages, it acutely impacts infants, the elderly, young children and others with compromised immune systems. RSV is the number one cause of hospitalization in infants ages 0 to 12 months in the U.S. and is a significant cause of infant morbidity and mortality globally. Current estimates indicate that RSV is responsible for over 30 million new acute lower respiratory infection episodes and between 150,000 and 200,000 deaths in children under five years old. In the U.S., nearly all children become infected with RSV before they are two years old; it has been associated with 20% of hospitalizations and 15% of office visits for acute respiratory infection in young children.
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