At the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2026 conference in Munich, Germany, late-breaking data on Moderna’s seasonal influenza vaccine candidate, mRNA-1010, was presented.
mRNA-1010 has been accepted for regulatory review in the US, EU, Canada, and Australia. The US Food and Drug Administration (FDA) has assigned mRNA-1010 a Prescription Drug User Fee Act (PDUFA) target date of 5 August 2026. If approved, mRNA-1010 will be the first seasonal influenza mRNA vaccine on the market.
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Influenza vaccines produced via mRNA technology will have a shorter production time than egg-based, cell-based, or recombinant vaccines, which are the seasonal influenza vaccines currently on the market. This decrease in production time means that the vaccines can be made closer to the start of flu season, thereby allowing for a better match to that season’s circulating influenza strains and overall improved vaccine effectiveness.
In Moderna’s Phase III studies of mRNA-1010, the vaccine candidate demonstrated superior immunogenicity compared to a licensed standard-dose seasonal influenza vaccine in adults 18–64 years of age, as well as compared to a high-dose licensed seasonal influenza vaccine in adults 65 years of age and older. The vaccine candidate also demonstrated superior prevention of influenza-like illness (ILI) in adults 50 years of age and older.
The data presented by Moderna at ESCMID Global 2026 was an exploratory post hoc analysis, which retrospectively analysed adults 50 years of age and older who had received repeat mRNA-1010 vaccinations through previous clinical trials. Over 2,000 study participants were identified as having been enrolled in two of Moderna’s Phase III studies and were eligible for this analysis. The participants were segmented into four groups: group 1 had received two doses of mRNA-1010 (one during each of the Phase III studies they participated in); group 2 received an active comparator in the first Phase III study followed by mRNA-1010 in the most recent Phase III study; group 3 received mRNA-1010 in the first Phase III study followed by an active comparator in the most recent Phase III study; and group 4 received two doses of an active comparator (one during each of the Phase III studies).
The study participants in groups 1 and 2, those who had most recently received mRNA-1010, elicited higher immune responses compared to those who had most recently received the active comparator. Geometric mean fold rises (GMFR) ranged from 3.2 to 5.1, depending on the influenza strain, in groups 1 and 2, compared with values of 1.5–2.4 in groups 3 and 4. Further, the participants in group 1 did not exhibit attenuation due to repeated mRNA-1010 vaccination. Vaccine efficacy was also found to be the highest among study participants in groups 1 and 2, where ILI events were 1.75% and 1.94%, respectively. ILI events in groups 3 and 4 were 2.7% and 3.59%, respectively. Adverse events were most frequently observed among study participants in groups 1 and 2. The most frequently reported adverse events in these groups included injection-site pain (67%–69%), fatigue (43%–45%), myalgia (34%–36%), and headache (30%–33%).
Unsolicited adverse events, including serious adverse events, were similar across all study groups. Overall, no new safety concerns were observed with repeated mRNA-1010 vaccination.
