Novavax, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, announced today that Gregory Glenn, M.D., SVP, Research and Development is presenting new immunogenicity data from Novavax' RSV F-Protein Nanoparticle vaccine candidate (RSV F vaccine) clinical trials at the 8th Vaccine & ISV Congress in Philadelphia, PA.
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 Gregory Glenn, M.D., SVP, Research and Development at Novavax. "These new clinical data, along with the cotton rat model, continue to build our confidence in the potential efficacy of our vaccine and our plan to initiate three RSV clinical trials, for maternal immunization, pediatrics and the elderly in the third and fourth quarter of this year."
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. The World Health Organization (WHO) estimates that the global disease burden for RSV is 64 million cases. Because there is no approved prophylactic vaccine, an RSV vaccine has the potential to protect millions of patients from this far-reaching unmet medical need.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.