Moderna Investigational Dual Flu/COVID-19 Vaccine Shows Positive Phase 1/2 Results

Moderna on Wednesday announced topline data from its ongoing phase 1/2 trial for the company’s investigational combination vaccine against both influenza and COVID-19, mRNA-1083, which proved as effective as licensed individual vaccines against the individual viruses.

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"Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems,” said Moderna CEO Stéphane Bancel. “We are excited to move combination respiratory vaccines into phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat…”

The ongoing phase 1/2 clinical trial is a randomized, observer blind study to evaluate the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine, Fluarix (GSK), in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD (Sanofi), in adults 65-79 years of age.

For both age groups, mRNA-1083 was compared to a standard dose of Moderna’s Spikevax COVID-19 bivalent booster shot.

Early-stage findings. The mRNA-1083 candidate 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, according to Moderna.

Geometric mean titer (GMT) ratios for mRNA-1083 relative to both Fluarix and Fluzone HD were >1.0 for all 4 vaccine strains. The GMT ratios of mRNA-1083 relative to Spikevax bivalent were >0.9 in adults 50 to 64 years of age and > 1.0 in adults 65 to 79 years of age.

Safety. Moderna reported no new safety concerns for mRNA-1083 compared with the individual vaccines. Overall local and systemic adverse reactions were similar to those observed in the Spikevax COVID-19 group in the trial. Severity of the majority of adverse reactions was assessed as grade 1 or 2; grade 3 solicited local or solicited systemic reactions were reported in less than 4% of participants aged 50 years and older.

Phase 3. Moderna expects to begin the phase 3 trial of mRNA-1083 before the end of the year, according to the statement, and is targeting potential regulatory approval for the combination vaccine in 2025.

Source: Moderna announces positive phase 1/2 data from mRNA-1083, the company's combination vaccine against influenza and COVID-19. News release. Moderna. October 4, 2023. Accessed October 5, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Positive-Phase-12-Data-from-mRNA-1083-the-Companys-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx