Maddie Meyer/Getty Images News Moderna ( NASDAQ: MRNA ) said Monday that its investigational combination vaccine to protect against both COVID-19 and influenza elicited higher immune responses in adults 50 years and older compared to licensed comparator vaccines used in a late-stage trial. mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, the drugmaker’s next-generation COVID-19 vaccine candidate. The experimental combo shot met its primary endpoints in a Phase 3 trial comprising approximately 4,000 adults in two independent age group cohorts.
One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD, Sanofi’s ( SNY ) enhanced influenza vaccine, and Spikevax, Moderna's currently licensed COVID-19 vaccine. The other cohort of adults 50 to 64 years of age compared mRNA-1083 to co-administered, Fluarix by GSK ( GSK ), and Spikevax. “In both age cohorts, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2,” the company said .
The vaccine also met non-inferiority criteria in both age cohorts and showed an acceptable tolerability and safety profile. Moderna ( MRNA ) plans to present the Phase 3 clinical data for the vaccine at an upcoming medical conference as well as submit it for publication. The company will engage with regulators on next steps.
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