The first participant has been dosed in a Phase 3 study of Moderna’s Flu-COVID vaccine candidate (mRNA-1083) in the US, according to the company. The trial is expected to enroll approximately 8,000 adults in the Northern Hemisphere.
The Phase 3 study will evaluate the immunogenicity, safety, and reactogenicity of mRNA‐1083 as compared with active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in two independent age‐group sub‐study cohorts involving 4,000 adults 65 years and older and 4,000 adults 50 to <65 years of age.
The mRNA-1083 candidate selected to advance to Phase 3 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 1/2 study.
The Moderna Flu-COVID Vaccine has the potential to efficiently reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SARS‐CoV‐2 viruses in a single injection, the company says. mRNA‐1083 offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations. This approach could benefit public health by synergistically increasing coverage rates against influenza and SARS‐CoV‐2 viruses.
The Company continues to target a potential initial regulatory approval for the combination vaccine in 2025.