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FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
On Jan. 15, 2020, Novavax, a late-stage biotechnology company developing next-generation vaccines, announced that FDA has granted fast track designation for its NanoFlu, a recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M, a next-generation, patented saponin-based adjuvant, for use by adults 65 years of age and older.
The vaccine is in an ongoing Phase III clinical trial intended to evaluate its immunogenicity and safety compared to the quadrivalent formulation of Fluzone, a Sanofi influenza vaccine. The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile. Top-line clinical data from the trial is expected to be presented by the end of the first quarter of 2020 and could support a biologics license application as well as future licensure of NanoFlu using FDA’s accelerated approval pathway.
“[FDA’s] decision to grant [f]ast [t]rack [d]esignation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population, which often experiences serious and sometimes life-threatening complications, of the disease,” said Stanley C. Erck, president and CEO of Novavax, in a company press release. “We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with [FDA] through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”