On June 10, Moderna announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, producing a higher immune response than the licensed comparator vaccines used in the trial.
A press release on the announcement says that “mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.”
Further, “The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier:NCT06097273) is a randomized, observer-blind, active control study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4,000 adults each. One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD®, an 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®, a standard dose influenza vaccine, and Spikevax.”
mRNA-1083 showed an acceptable tolerability and safety profile. The bulk of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. The most solicited adverse reactions were injection site pain, fatigue, myalgia, and headache.
Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference as well as submit it for publication. The company says it plans to engage with regulators on next steps.
