The FDA has approved Moderna’s messenger RNA (mRNA) seasonal influenza vaccine, mFLUSIVA (mRNA-1010), for the prevention of seasonal influenza in adults aged 50 years and older. mFLUSIVA is now the first and only mRNA standalone seasonal influenza vaccine on the market, marking a major advancement for the field. The approval is expected to cement Moderna’s position in the seasonal influenza vaccines market.
Influenza vaccines produced using mRNA technology will have a shorter production time than seasonal influenza vaccines currently on the market, including egg-based vaccines, cell-based vaccines, and recombinant vaccines. According to Moderna, while traditional seasonal influenza vaccines can take approximately six months from strain selection to launch, its vaccine takes only two to three months to produce. This decrease in production time means that the vaccines can be made closer to the start of influenza season, thereby allowing for a better match to that season’s circulating influenza strains.
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mFLUSIVA’s FDA approval was supported by data from a pivotal Phase III trial, which evaluated the safety, reactogenicity, and relative vaccine efficacy of mFLUSIVA versus an active comparator vaccine in over 40,000 adults aged 50 years and older. The most common adverse events were injection site pain, fatigue, headache, and myalgia, and were observed more frequently in the mFLUSIVA group versus the active comparator group. However, the mRNA vaccine was evaluated as being 26.6% more efficacious than the active comparator, which met the criteria for non-inferiority, superiority, and higher-level superiority. Moderna has announced that it expects to have mFLUSIVA available for older adults in time for the 2026–2027 influenza season.
mFLUSIVA’s path to FDA approval was well documented months earlier, when the FDA reversed course and announced that it would initiate a review of the vaccine one week after the FDA’s Center for Biologics Evaluation and Research (CBER) notified Moderna that it would not initiate a review of the seasonal influenza vaccine candidate and issued a Refusal-to-File (RTF) letter, citing concerns over the choice of the vaccine comparator used in the Phase III trial.
CBER’s RTF letter cited the choice of a licensed, standard-dose, seasonal influenza vaccine used as a vaccine comparator in the trial, rather than a vaccine specifically recommended for older adults such as a high-dose or adjuvanted vaccine, as the reason for refusing to initiate a review of Moderna’s biologics license application (BLA) for mRNA-1010. Moderna provided additional data from another Phase III trial comparing mRNA-1010 and a licensed, high-dose, seasonal influenza vaccine, in addition to proposing a revised regulatory pathway for mRNA-1010, including full approval for adults ages 50–64 years, accelerated approval for adults ages 65 years and older, and a post-marketing study in older adults. All of the Phase III data that Moderna reported demonstrated the statistical superiority of mRNA-1010 over the comparator vaccines.
The FDA approval of mFLUSIVA stakes Moderna’s claim in the seasonal influenza vaccines market. As the uptake of mFLUSIVA increases due to its increased effectiveness, the market share of existing influenza vaccines is expected to decrease, with Moderna becoming established as a key player in the seasonal influenza vaccines field. Moderna is already a leader in the mRNA vaccines space. According to GlobalData, of the 27 approved mRNA vaccines globally, the majority are Moderna’s assets.
