Novavax, today announced positive initial results from the Phase 3 trial evaluating its COVID-19-Influenza Combination (CIC) vaccine and the stand-alone trivalent nanoparticle influenza vaccine (tNIV). The trial data demonstrated that both vaccine candidates generated immune responses comparable to currently licensed vaccines—Nuvaxovid® for COVID-19 and Fluzone® HD for influenza.
The study assessed immune responses in approximately 2,000 adults aged 65 and older, focusing on three influenza strains (H1N1, H3N2, and B) and SARS-CoV-2. Although not statistically powered for definitive conclusions, the trial provided valuable descriptive insights to support a future registrational Phase 3 program.
Both the CIC and tNIV vaccines elicited strong immune responses, with a 2.4 to 5.7-fold increase over baseline levels. These responses were consistent with those seen in licensed comparator vaccines. Reactogenicity profiles were also favorable, with both vaccines being well tolerated. More than 98% of reported solicited adverse events were mild or moderate in severity.
Dr. Ruxandra Draghia-Akli, Executive Vice President and Head of Research and Development at Novavax, stated, “Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated. This data set strengthens our previous Phase 2 findings and supports ongoing discussions with potential partners.”
Neutralizing antibody levels measured on Day 28 post-vaccination confirmed immunogenicity for all targeted strains in both the CIC and tNIV arms, mirroring the performance of Nuvaxovid and Fluzone HD. The results contribute to Novavax’s broader strategy to develop next-generation combination vaccines that offer simplified protection against multiple respiratory viruses in a single shot.
This Phase 3 data reinforces the potential of Novavax’s nanoparticle vaccine technology in older adult populations, a group especially vulnerable to severe outcomes from influenza and COVID-19. The company plans to use these findings to guide further clinical development and partnership efforts for its CIC and tNIV candidates.