Moderna Announces Positive Phase 3 Results of Its Combination Flu-Covid Vaccine

Moderna announced that a phase 3 study of mRNA-1083, an investigational combination flu and Covid vaccine, met its primary endpoints, producing a higher immune response than the authorized comparator vaccines used in the study.

“Combination vaccines can reduce the burden of respiratory viruses on healthcare systems and pharmacies, while also offering people more convenient vaccination options. This may improve compliance and provide greater protection against seasonal diseases.“Said Stéphane Bancel, CEO of Moderna.

“Moderna is the only company with a positive Phase 3 combination flu and Covid vaccine. Building on positive Phase 3 data across our respiratory portfolio, we continue to address important unmet medical needs and advance healthcare advancements.”

mRNA-1083 contains components of Moderna’s seasonal influenza vaccine candidate, mRNA-1010, and mRNA-1283, Moderna’s next-generation Covid vaccine candidate. Each study vaccine independently demonstrated positive results in phase 3 clinical trials.

The ongoing phase 3 clinical trial (ClinicalTrials.gov identifier: NCT06097273) is a blinded, randomized, active-controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age groups of approximately 4,000 adults each. One cohort of adults aged 65 and older compared mRNA-1083 to Fluzone HD, an improved flu vaccine, and Spikevax, Moderna’s currently approved Covid vaccine. Another group of adults aged 50 to 64 years compared mRNA-1083 with co-administration of Fluarix, a standard dose of the flu vaccine, and Spikevax.

Immune reactions detected single-dose mRNA-1083 was noninferior to licensed, routinely recommended, and co-prescribed comparators. In both age cohorts, mRNA-1083 also induced a statistically significantly greater immune response against three influenza virus strains (H1N1, H3N2 and B/Victoria) and against SARS-CoV-2. In the 65 years and older cohort, overall geometric mean ratios (GMRs) in the mRNA-1083 group compared with the Fluzone HD group for influenza strains were 1.155 (95% CI: 1.094, 1.220) for A/H1N1, 1.063 (95% CI: 1.007 , 1.122) for A/H3N2 and 1.118 (95% CI: 1.070, 1.167) for B/Victoria. The GMR of mRNA-1083 versus Spikevax for the Omicron XBB.1.5 variant of SARS-CoV-2 was 1.641 (95% CI: 1.526, 1.765).

In the 50-64 year cohort, GMRs of the mRNA-1083 group compared to the Fluarix group for influenza virus strains were 1.414 (95% CI: 1.333, 1.500) for A/H1N1, 1.380 (95% CI: 1.310, 1.454) for A/ H3N2 and 1.216 (95% CI: 1.163, 1.270) for B/Victoria. The GMR of mRNA-1083 versus Spikevax for the Omicron XBB.1.5 variant of SARS-CoV-2 was 1.308 (95% CI: 1.219, 1.404).

Immunogenicity against influenza B/Yamagata strain and mRNA-1083 was also tested. met non-inferiority criteria in both age groups. Due to the disappearance of the B/Yamagata lineage from circulation, WHO has recommended a trivalent influenza vaccine formulation without B/Yamagata for the 2024/2025 vaccines.

mRNA-1083 demonstrated an acceptable safety and tolerability profile.. The majority of adverse reactions reported were grade 1 or 2 in severity and were consistent with the licensed vaccines used in the study. The most common adverse reactions were pain at the injection site, fatigue, myalgia and headache.

Moderna plans to present phase 3 clinical data for mRNA-1083 at an upcoming medical conference and also submit it for publication.