Moderna is preparing to file for approval of its mRNA flu vaccine after it proved more effective than the standard of care in a Phase III study.
The study evaluated the relative vaccine efficacy (rVE) of mRNA-1010 compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. The trial enrolled 40,805 participants from 11 countries.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The pivotal study (NCT06602024) showed mRNA-1010 to be superior to the current vaccine with an rVE of 26.6%. Each flu strain within the vaccine also showed high efficacy, including A/H1N1 with A/H3N2, and the B/Victoria lineages, with rVEs of 29.6%, 22.2% and 29.1% respectively.
Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status.
Moderna CEO Stéphane Bancel said: “The severity of this past flu season underscores the need for more effective vaccines. An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for Covid-19 combination vaccines.”
In a previous Phase III trial, mRNA-1010 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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe safety and tolerability of mRNA-1010 was also consistent with a previous Phase III study with most adverse events (AEs) being mild with injection site pain being the most common AE.
Based on this second Phase III readout, Moderna plans to engage with regulators on filing submissions for mRNA-1010.
The trial results come amid a time of upheaval in the vaccine sector, as US health secretary Robert F Kennedy, Jr (RFK) recently fired all members of the Advisory Committee on Immunization Practices (ACIP) panel, replacing them with prominent vaccine sceptics and critics of Covid-19 vaccines, as well as associated public health measures such as lockdowns.
The ACIP recommends who should be vaccinated and when these immunisations should occur to the US Centers for Disease Control and Prevention.
mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
