Novavax, Inc., a biotechnology company developing next-generation vaccines for serious infectious diseases, announced complete results from a pivotal Phase 3 clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant.
 
The trial evaluated the immunogenicity and safety of NanoFlu in older adults compared to a leading U.S.-licensed quadrivalent influenza vaccine. In the complete analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine.
 
“Despite high vaccination rates, limitations in the effectiveness of existing influenza vaccines leave significant disease burden unaddressed, particularly in older adults,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “These encouraging results reflect NanoFlu’s promise, especially as we currently have a combination COVID-19-influenza vaccine under evaluation for protection against two life-threatening diseases simultaneously.”
 
Novavax’ NanoFlu achieved the trial’s primary endpoints, demonstrating non-inferior immunogenicity to Fluzone Quadrivalent against all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains (22-66% increased) and six heterologous A/H3N2 strains (34-46% increased) as compared to Fluzone Quadrivalent.
 
Additionally, NanoFlu showed potent induction of polyfunctional antigen-specific CD4+ T-cells against A/H3N2 and B/Victoria strains, with a 126–189% increase in various post-vaccination cell-mediated immunity markers as compared to Fluzone Quadrivalent.