Novavax’s COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial
Both vaccine candidates induced robust immune responses across all antigens tested
No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials
Novavax continues to pursue partnering opportunities to advance further development of these programs
GAITHERSBURG, MD, USA I June 11, 2025 I Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) 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.
Day 28 Neutralizing Antibody Responses Following Administration of CIC, tNIV, Fluzone HD and Nuvaxovid Vaccines
Day 28 Neutralizing Antibody Responses Following Administration of CIC, tNIV, Fluzone HD and Nuvaxovid Vaccines
“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 (2.4-5.7-fold over baseline). Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (>98%) solicited adverse events were mild or moderate in severity.
This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. This trial was not adequately powered to demonstrate statistical significance. These results build on previous Phase 2 data.
About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world’s most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M® adjuvant. The Company’s growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information.
Both vaccine candidates induced robust immune responses across all antigens tested
No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials
Novavax continues to pursue partnering opportunities to advance further development of these programs
GAITHERSBURG, MD, USA I June 11, 2025 I Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) 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.
Day 28 Neutralizing Antibody Responses Following Administration of CIC, tNIV, Fluzone HD and Nuvaxovid Vaccines
Day 28 Neutralizing Antibody Responses Following Administration of CIC, tNIV, Fluzone HD and Nuvaxovid Vaccines
“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 (2.4-5.7-fold over baseline). Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (>98%) solicited adverse events were mild or moderate in severity.
This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. This trial was not adequately powered to demonstrate statistical significance. These results build on previous Phase 2 data.
About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world’s most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M® adjuvant. The Company’s growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information.
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