In June 2024 Moderna announced that its Phase III trial of mRNA-1083 has met primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial. The vaccine is an investigational combination vaccine against influenza and COVID-19, comprising components of mRNA-1010, Moderna’s seasonal influenza candidate, and mRNA-1283, its next-generation COVID-19 candidate
The trial
The ongoing Phase III trial is a randomised, observer-blind, active control study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age group cohorts of around 4,000 adults each. One cohort, comprising adults 65 yeras 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, adults between the ages of 50 and 64, 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 and elicited “statistically significantly higher immune responses” to three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2 in both cohorts. The vaccine also showed an “acceptable” tolerability and safety profile. Moderna expects to present the data at a medical conference and submit for publication.
Stéphane Bancel, Chief Executive Officer of Moderna, commented that “combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies”. Furthermore, they “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 III flu and COVID combination vaccine. Building on the momentum of positive Phase III data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.”
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