Moderna announces ‘positive’ Phase 3 data for combination flu/COVID vaccine

Moderna announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial. The ongoing Phase 3 clinical trial 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. The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators. In both age cohorts, mRNA-1083 also elicited statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2. In the 65 years and older cohort, overall Geometric Mean Ratios of the mRNA-1083 group compared to the Fluzone HD group for the influenza strains were 1.155 for A/H1N1, 1.063 for A/H3N2 and 1.118 for B/Victoria. The GMR of mRNA-1083 compared to Spikevax for the SARS-CoV-2 variant Omicron XBB.1.5 was 1.641. “Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses. Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health,” said Stephane Bancel, Chief Executive Officer of Moderna. Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference as well as submit it for publication and the company will engage with regulators on next steps, it stated.