NanoFlu Shows Promise in Phase 3 Trial Among Older Adults

Novavax announced that its NanoFlu recombinant quadrivalent influenza vaccine candidate has received fast track status by the U.S. Food and Drug Administration, and fulfilled all primary endpoints in a phase 3 trial testing its effectiveness and overall safety in older adults, reports Healio . The trial compared NanoFlu with Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMTs), the difference in seroconversion rates (SCRs), and overall safety. Included in the trial were 2,652 healthy adults 65 or older in 19 U.S. clinical sites who were randomly assigned to receive either NanoFlu or comparator. Novavax said NanoFlu realized the primary endpoints for GMT and SCR for all four strains included in the vaccine. Secondary endpoints evaluated GMTs and SCRs with a hemagglutination inhibition (HAI) assay based on wild-type reagents, "which are expected to provide a more accurate assessment of clinically relevant HAI antibody responses against circulating wild-type viruses." NanoFlu exhibited 66 percent GMT responses and 10.4 percent SCR responses to Fluzone Quadrivalent's 24 percent GMT and 11.4 percent SCR across all four strains. "These strong phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults," said Novavax CEO Stanley C. Erck.