What You Should Know
The vaccine demonstrated immunogenicity against all four influenza strains and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax booster.
The safety data for mRNA-1083 reported rates of solicited local and systemic adverse reactions being similar to those seen with the standalone COVID-19 vaccine.
If the vaccine continues to show favorable results in further trials and data collection, Moderna aims to seek regulatory approval for the combination vaccine in 2025.
Moderna announced topline data from its ongoing phase 1/2 trial for their investigational Influenza-COVID-19 vaccine, mRNA-1083, which showed immunogenicity against all 4 influenza strains.
"Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies. 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 posed to people by these viruses."
What the Data Showed
The phase 1/2 clinical trial is a randomized, observer blind study that evaluated the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine, Fluarix, in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age.
For both age groups, mRNA-1083 was compared against Spikevax booster. 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 mRNA-1083 vaccine resulted in geometric mean titer (GMT) ratios >1.0 relative to Fluarix in adults 50-64 years of age, for all four influenza vaccine strains. GMT ratios for mRNA-1083 relative to Fluzone HD in adults 65-79 were also >1.0, for all four influenza 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, relative to Spikevax.
The Safety Profile
Reported rates of solicited local and systemic adverse reactions for mRNA-1083 administration were similar to the standalone COVID-19 vaccine group in the trial. The majority of solicited adverse reactions were grade 1 or 2 in severity. Grade 3 solicited local or solicited systemic reactions were reported in less than 4% of participants ages 50 and above. No new safety concerns were identified for mRNA-1083 compared to the standalone vaccines.
The company is reporting it will start its phase 3 trial later this year. If all continues to progress favorable, Moderna is targeting potential regulatory approval for the combination vaccine in 2025.