U.S. FDA Grants Fast Track Designation to Novavax’ RSV F-Protein Nanoparticle Vaccine for Protection of Infants Via Maternal Immunization

November 20, 2014 Novavax, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine candidate (RSV F vaccine) for protection of infants via maternal immunization. “The FDA’s granting of Fast Track designation …

Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age

Vaccine candidate was well-tolerated with no vaccine-related serious adverse events Highest immune responses observed with a single dose of vaccine combined with aluminum phosphate adjuvant Women with the lowest baseline levels of RSV neutralizing antibodies had the largest increases following immunization, consistent with prior data Palivizumab-like antibodies exceeded levels observed in previous trials  High levels of antibodies developed within 14 days after …