The U.S. Food and Drug Administration has granted approval to Moderna’s mRNA-based influenza vaccine for adults aged 65 and older, marking the first time mRNA technology has been used in a seasonal flu shot. The vaccine, known as mRNA-1010, targets four influenza strains recommended by the World Health Organization for the 2024–2025 season and is designed to provide enhanced immune response in older adults, who often experience reduced effectiveness from traditional flu vaccines.
Clinical trial data showed the vaccine generated a robust antibody response against circulating flu strains, with non-inferior immunogenicity compared to a standard-dose quadrivalent flu vaccine. In a Phase 3 study involving over 8,000 participants aged 65 and above, mRNA-1010 demonstrated superior antibody titers against two influenza A strains and one influenza B strain. The most commonly reported side effects were mild to moderate and included pain at the injection site, fatigue, headache, and muscle aches, typically resolving within a few days.
This approval validates the potential of mRNA platform technology beyond COVID-19, offering a faster, more adaptable approach to vaccine development, said Dr. Paul Burton, Moderna’s Chief Medical Officer. We believe this technology can improve strain matching and accelerate production timelines, which is critical for staying ahead of evolving flu viruses.
The mRNA platform allows for rapid redesign of vaccine components in response to circulating strains, unlike traditional methods that require months of egg-based cultivation. This agility could prove vital in years when the dominant flu strains drift significantly from those predicted in the annual vaccine formulation. Public health officials note that improved vaccine effectiveness in older adults could reduce hospitalizations and deaths, particularly in high-risk groups.
Looking ahead, Moderna plans to pursue expanded age indications and explore combination vaccines that could protect against both influenza and respiratory syncytial virus (RSV) in a single shot. The company is also investigating next-generation flu vaccines that target more conserved parts of the virus to potentially offer broader, longer-lasting protection. Experts caution that while the technology is promising, real-world effectiveness will depend on factors such as uptake rates, timing of administration, and how well the vaccine matches circulating strains each season.
For decades, flu vaccine production has relied on growing viruses in chicken eggs or mammalian cells, a process that can introduce mutations and slow response times. The shift to mRNA represents a broader trend toward platform-based vaccinology, where the same delivery system can be adapted for different pathogens. As respiratory virus season approaches, health authorities encourage older adults to consult with their healthcare providers about vaccination options, including the newly available mRNA-based flu shot.
Moderna’s mRNA Flu Vaccine Marks a Shift in Preventive Care
The approval of Moderna’s mRNA flu vaccine signals a potential turning point in how seasonal vaccines are developed and distributed. By leveraging the speed and flexibility of mRNA technology, manufacturers may be able to respond more quickly to antigenic drift and reduce the guesswork involved in strain selection. This could lead to higher overall vaccine effectiveness, especially in years when traditional methods fall short due to mismatched strains.
Beyond influenza, the success of mRNA vaccines in infectious disease prevention is accelerating research into applications for other respiratory illnesses, cancer therapeutics, and autoimmune disorders. Regulatory agencies are increasingly open to platform-based approvals, which could streamline future vaccine development. As more data accumulates on long-term safety and real-world performance, mRNA vaccines may become a standard tool in preventive medicine, offering faster, more precise protection against evolving threats.
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