On October 24, 2023, Moderna, Inc. announced that the first participant was dosed in a phase III study of the company’s combination vaccine candidate against influenza and COVID-19 (mRNA-1083) in the U.S. The mRNA-1083 vaccine is Moderna’s first respiratory combination vaccine candidate to enter a phase III trial and is projected to enroll about 8,000 adults in the Northern Hemisphere.

The initiation of the phase III trial follows promising data from a phase I/II trial where mRNA-1083 demonstrated robust immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile, compared with licensed standalone vaccines.

The phase III study will assess the immunogenicity, safety, and reactogenicity of mRNA-1083 compared with active control, coadministered licensed influenza and SAR-CoV-2 vaccines in two independent age-group substudy cohorts involving 4,000 adults aged 65 years and older and 4,000 adults aged 50 to <65 years.

The mRNA-1083 candidate selected to advance to phase III attained hemagglutination inhibition antibody titers comparable to or greater than both licensed quadrivalent influenza vaccines and achieved SARS-CoV-2 neutralizing antibody titers comparable to the Spikevax bivalent booster in the phase I/II study.

Moderna noted that the mRNA-1083 vaccine has the potential to efficiently decrease the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SAR-CoV-2 viruses in a single injection. The mRNA-1083 vaccine also offers greater convenience and has the potential to lead to improved adherence to vaccine recommendations. The manufacturer also indicates that a combination vaccine provides an approach that could benefit public health by synergistically strengthening 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.

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