Moderna’s Influenza-COVID-19 Vaccine Demonstrates Immunogenecity

Results from Moderna’s Phase I/II clinical trial that evaluated the safety and immunogenicity of its influenza-COVID-19 vaccine, mRNA 1083, showed immunogenicity against all four influenza strains compared to a standard dose of the influenza vaccine, Fluarix, in adults 50 to 64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65 to 79 years of age. In addition, for both age groups, when comparing the mRNA-1083 candidate selected to advance to Phase III, findings showed it achieved hemagglutination inhibition antibody titers similar to or greater than both licensed quadrivalent influenza vaccines and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster in the Phase I/II study.

Specifically, the mRNA-1083 vaccine resulted in geometric mean titer (GMT) ratios >1.0 relative to Fluarix in adults 50 to 64 years of age for all four influenza vaccine strains. GMT ratios for mRNA-1083 relative to Fluzone HD in adults 65 to 79 were also >1.0 for all four influenza vaccine strains. The GMT ratios of mRNA-1083 relative to Spikevax bivalent were >0.9 in adults 50 to 64 years of age and >1.0 in adults 65 to 79 years of age.

Reported rates of solicited local and systemic adverse reactions for mRNA-1083 administration were similar to the standalone COVID-19 vaccine group in the trial. The majority of solicited adverse reactions were grade 1 or 2 in severity. Grade 3 solicited local or solicited systemic reactions were reported in less than four percent of participants ages 50 and older. And, no new safety concerns were identified for mRNA-1083 compared to the standalone vaccines.

Moderna reported it would start its Phase III trial later in 2023, and with favorable results, the company is targeting potential regulatory approval for the combination vaccine in 2025.