The FDA granted fast track designation to NanoFlu, a recombinant quadrivalent seasonal influenza vaccine candidate, for adults aged 65 years and older.
“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,” President and Chief Executive Officer of Novavax Stanley C. Erck said in a release.
NanoFlu is enrolled in a phase 3 trial that will evaluate the immunogenicity and safety of NanoFlu compared with the quadrivalent formulation of Fluzone, according to the release from Novavax. The trial also aims to demonstrate the noninferior immunogenicity of NanoFlu compared with Fluzone. Data from the trial are expected by the end of the first quarter of 2020 and could support future licensing of NanoFlu through the FDA’s accelerated approval pathway.
According to data from a previously reported phase 2 clinical trial, NanoFlu elicited improved immune responses in older adults compared with Fluzone and all formulations of NanoFlu were well tolerated and prompted significant immune response to all four strains of influenza included in the vaccine.
“We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness,” Erck said. “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.” – by Caitlyn Stulpin