WASHINGTON (dpa-AFX) - Biotechnology company Moderna, Inc. (MRNA) announced Monday positive results from a Phase 3 efficacy study evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.
mRNA-1010 demonstrated superior rVE of 26.6% higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older in the overall study population.
Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 rVE of 29.6%), A/H3N2 rVE of 22.2%), and the B/Victoria lineages rVE of29.1%.
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, mRNA-1010 had already 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.
The Phase 3 study was a randomized, observer-blind, active-controlled, case-driven, pivotal efficacy, immunogenicity and safety study. The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months.
Safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. The CompModerna reports Positive Phase 3 Results for MRNA Seasonal Flu Vaccine Candidate
Moderna, Inc. (MRNA) announced Monday positive results from a Phase 3 efficacy study evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.
mRNA-1010 demonstrated superior rVE of 26.6% higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older in the overall study population.
Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 rVE of 29.6%), A/H3N2 rVE of 22.2%), and the B/Victoria lineages rVE of29.1%.
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, mRNA-1010 had already 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.
The Phase 3 study was a randomized, observer-blind, active-controlled, case-driven, pivotal efficacy, immunogenicity and safety study. The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months.
Safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. The Company will now engage with regulators on filing submissions for mRNA-1010.
any will now engage with regulators on filing submissions for mRNA-1010.
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