In a significant development, Moderna, Inc. (NASDAQ: MRNA) has successfully dosed the first participant in the Phase 3 study of its groundbreaking combination vaccine candidate, mRNA-1083, designed to target both influenza and COVID-19. This marked a crucial milestone as mRNA-1083 is the company’s first respiratory combination vaccine candidate to enter the Phase 3 trial.
The decision to move into Phase 3 followed promising results from the Phase 1/2 trial, where mRNA-1083 demonstrated robust immunogenicity against both influenza and COVID-19. Importantly, the vaccine showed an acceptable reactogenicity and safety profile when compared to licensed standalone vaccines.
The Phase 3 study, conducted in the U.S., aimed to enroll approximately 8,000 adults in the Northern Hemisphere. It focused on evaluating the immunogenicity, safety, and reactogenicity of mRNA-1083 in two independent age-group sub-study cohorts involving 4,000 adults aged 65 and older and 4,000 adults aged 50 to <65.
Results from the Phase 1/2 trial indicated that mRNA-1083 achieved antibody titers comparable to or greater than licensed quadrivalent influenza vaccines and SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster.
With its potential to simultaneously protect against influenza and SARS-CoV-2 in a single injection, mRNA-1083 is positioned to efficiently reduce the overall burden of acute viral respiratory diseases. The vaccine not only offers enhanced convenience but also has the potential to boost compliance with vaccination recommendations, ultimately contributing to increased coverage rates against both viruses.
Moderna aims for potential initial regulatory approval of mRNA-1083 in 2025. This achievement underscores Moderna’s commitment to advancing innovative solutions in vaccine development and its broader impact on public health.
