The United States Food and Drug Administration (FDA) has given the green light to Moderna's mRNA-based influenza vaccine, making it the first shot of its kind to be authorised in the US. The vaccine, marketed as mFLUSIVA, will be available to adults aged 50 and older starting with the 2026-2027 respiratory virus season.
The approval marks a significant milestone for messenger RNA technology, which first came to prominence during the Covid-19 pandemic. Moderna's chief executive, Stéphane Bancel, said the decision “reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.” He added that the vaccine “provides an important new option for America's seniors.”
The FDA's decision rests on data from a phase 3 clinical trial involving nearly 41,000 adults aged 50 and older across 11 countries, as well as a separate study of almost 3,000 adults aged 65 and older in the United States. The results showed the vaccine was effective in preventing influenza illness in this age group, which is particularly vulnerable to severe complications from the virus.
What this means for Europe
While the US has moved first, European regulators are still examining the vaccine. The European Medicines Agency (EMA) is currently evaluating mFLUSIVA, but no decision has been announced yet. Earlier this year, the EMA approved a different mRNA product, mCombriax, which combines protection against Covid-19 and flu for adults aged 50 and over. That combined vaccine has not been approved in the US.
The divergence highlights the different regulatory timelines on either side of the Atlantic. For European public health officials, the arrival of mRNA flu vaccines could eventually offer a more flexible and faster-adapting tool to match circulating strains, especially as seasonal flu continues to cause tens of thousands of deaths across the continent each year.
Moderna has been expanding its mRNA pipeline beyond Covid-19, with candidates for respiratory syncytial virus (RSV), cytomegalovirus, and even cancer. The company is also working on an Ebola vaccine, with human trials underway as the outbreak in the Democratic Republic of Congo worsens. That research, while not directly related to flu, underscores the broader potential of the platform.
For now, European health authorities will be watching the US rollout closely. The 2026-2027 season will provide real-world data on how the vaccine performs outside clinical trials, including its safety profile and effectiveness against evolving flu strains. If the results are positive, the EMA may follow suit, giving European seniors access to a new generation of flu protection.
In the meantime, the approval is a reminder of how quickly vaccine technology is advancing. The mRNA platform, once a niche research interest, is now a cornerstone of pandemic preparedness and routine immunisation. As Europe continues to debate its own vaccine strategy, the US decision may well accelerate conversations in Berlin, Paris, and Brussels about how to integrate mRNA vaccines into national immunisation programmes.
For the broader transatlantic relationship, the news also comes at a time of heightened tension over trade and tariffs. The US Senate has recently passed a sanctions bill that could give President Trump new leverage against European goods. While the vaccine approval is a scientific matter, it is part of a wider picture in which American innovation and European regulation often intersect.
Ultimately, the FDA's decision is a clear signal that mRNA vaccines are here to stay. For Europe, the question is not whether to adopt them, but when and how. The EMA's ongoing review will be crucial in determining whether the continent can benefit from this new tool in the fight against seasonal influenza.
