The US FDA has granted Fast Track Designation for NanoFlu, a recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M, in adults 65 years of age and older, according to manufacturer Novavax.
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.
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.
“The FDA’s decision to grant Fast Track Designation 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. “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 the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”