Moderna has announced positive results from a phase 1/2 trial of its investigational mRNA combination vaccine against influenza and COVID-19.
The combined vaccine approach has the potential to alleviate the impact of both flu and COVID-19 while offering a combined administration, potentially simplifying immunisation practices and leading to higher vaccine uptake.
The ongoing phase 1/2 clinical trial is evaluating the safety and immunogenicity of the vaccine, called mRNA-1083, compared to GSK’s standard dose Fluarix flu vaccine in adults aged 50 to 64 years and Sanofi’s high-dose Fluzone flu vaccine in those aged 65 to 79 years.
For both age groups, mRNA-1083 was compared against Moderna’s standalone COVID-19 booster, Spikevax.
Results showed that the combination vaccine appeared effective against all four flu vaccine strains when compared with both Fluarix and Fluzone and achieved SARS-CoV-2 neutralising antibody levels similar to Spikevax.
Moderna also said the combination was found to be safe and tolerable and that the rates of adverse effects were similar to those experienced by the standalone COVID-19 vaccine group.
The company said it is now planning to begin a phase 3 trial of mRNA-1083 this year and is targeting potential regulatory approval for the combination vaccine in 2025.
Stéphane Bancel, Moderna’s chief executive officer, said: “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.
“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.”
The readout comes less than a month after Moderna shared positive phase 3 results for its mRNA influenza vaccine candidate, with mRNA-1010 shown to generate a stronger immune response against all four flu strains compared to Fluarix.
The vaccine was also shown in a separate phase 1/2 head-to-head study to induce a stronger immune response against three of the four strains compared to Fluzone and generated an equal response to the comparator against the fourth.