mRNA Steps Up: Europe Eyes a New Era for Flu Vaccines

Moderna's mRNA flu vaccine clears a key EMA hurdle, backed by trial data showing it outperforms standard flu shots in older adults

7 May 2026

Seasonal influenza is, in most years, a predictable enemy. Yet the 2024-2025 American flu season produced the highest hospitalisation rate in 15 years, a reminder that predictable and manageable are not the same thing. Into this gap steps Moderna, with an ambition to do for flu what its mRNA technology did for covid-19.

In January 2026, the company filed mRNA-1010, its experimental influenza vaccine, with the European Medicines Agency, making it the first mRNA flu candidate ever submitted for full regulatory approval on the continent. If cleared, Europe would become the first major market to license such a product. Applications are also pending in America, Canada, and Australia, with decisions expected no earlier than late 2026.

The clinical case has grown firmer. A phase-three trial of more than 22,500 adults aged 50 and older, published this week in the New England Journal of Medicine, found that mRNA-1010 offered 26.6% better protection against influenza than a standard licensed flu shot. Among those aged 65 and older, the advantage widened to 27.4%.

Speed is mRNA's structural selling point. Egg-based manufacturing, the industry standard for decades, takes months and leaves producers exposed when circulating strains diverge from seasonal forecasts. mRNA production can be updated and scaled more quickly, a genuine advantage in a domain where timing matters.

But mRNA-1010's progress has not been smooth everywhere. The American Food and Drug Administration initially declined to assess the submission in February 2026, citing a methodology dispute, before reversing that position. A formal decision is now scheduled for August 5th.

However, this European path, though more stable, carries its own complications. The trial measured mRNA-1010's performance against a standard-dose comparator. In practice, many European health systems already favour high-dose flu vaccines for older adults, a population that stands to gain most from any improvement. Health technology assessment bodies across EU member states will weigh that gap carefully before making reimbursement recommendations.

For now, mRNA flu vaccines sit in a promising but unresolved middle ground: clinically superior to an older baseline, commercially untested against the products they most need to displace.