Moderna Files Seeks Regulatory Approval From FDA, European Medicines Agency, Health Canada, And Therapeutic Goods Administration In Australia For Its Investigational Seasonal Influenza Vaccine, mRNA-1010, For Adults Aged 50 Years And Older

The regulatory applications are based on positive data from multiple Phase 3 studies. In a Phase 3 efficacy study (P304), mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with a relative vaccine efficacy (rVE) of 26.6% (95% CI; 16.7%, 35.4%) across all adults aged 50 years and older. Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%. In a previous Phase 3 study (P303), mRNA-1010 had demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine.

mRNA-1010 has been found to be well tolerated with a favorable safety profile. The majority of solicited adverse reactions (SARs) have been mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported.