Novavax Granted Fast Track Designation for NanoFlu in Older Adults

Novavax announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its NanoFlu recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M, in adults 65 and older, reports Globe Newswire . "We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness," said Novavax CEO Stanley C. Erck. "We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations." The ongoing Phase 3 clinical trial seeks to assess NanoFlu's immunogenicity and safety versus the quadrivalent formulation of Fluzone. The trial's main goals are demonstrating non-inferior immunogenicity as quantified by hemagglutination inhibition titers of vaccine homologous flu strains compared to Fluzone, and describing its safety profile. Top-line clinical data from the trial is expected by the end of the first quarter of this year and could support a U.S. biologics license application and future licensure of NanoFlu using the FDA's accelerated approval pathway.