Novavax, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older. The ongoing Phase 3 clinical trial is intended to evaluate the immunogenicity and safety of NanoFlu compared to the quadrivalent formulation of Fluzone. The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile. Top-line clinical data from the trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.