Novavax Announces Positive Results for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates

Results from the initial cohort of Novavax's COVID-19-Influenza Combination and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza vaccine candidates have shown both vaccines induced robust immune responses and were well tolerated in adults aged 65 and older. The Phase 3 trial 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. The data set adds to findings from Novavax's Phase 2 trial and will help inform discussions with potential partners.

Key Takeaways:

• The COVID-19-Influenza Combination and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza vaccine candidates induced robust immune responses to the vaccine strains, with a 2.4-5.7-fold increase over baseline.
• The vaccines were well tolerated, with nearly all (98%) solicited adverse events being mild or moderate in severity.
• The trial was designed to evaluate the safety and immunogenicity of the vaccine candidates compared to licensed comparators Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older.
• The results build on previous findings from Novavax's Phase 2 trial and will inform discussions with potential partners.

Statistics:

• 98% of solicited adverse events were mild or moderate in severity.
• The vaccine candidates induced a 2.4-5.7-fold increase in immune responses over baseline.
• The trial involved approximately 2,000 adults aged 65 and older.

Sources:

• Novavax, Inc. (2025) - PR Newswire (June 11, 2025)