Novavax reports results from CIC, tNIV Phase 3 trial

Novavax (NVAX) announced results of the initial cohort of its COVID-19-Influenza Combination and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid and Fluzone HD, respectively. This cohort was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program. “Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated,” said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. “This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners.” Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains. Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all solicited adverse events were mild or moderate in severity.