WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Moderna's mFlusiva, making it the first seasonal influenza vaccine based on messenger RNA technology to receive FDA approval in the United States.

The vaccine is approved for adults between 50 and 64 years old and received accelerated approval for people 65 and older, based on evidence of immune response while additional data are collected.

The regulatory decision represents a major milestone for mRNA vaccine technology, which became widely known through COVID-19 vaccines. Moderna is now applying the platform to seasonal influenza, a disease that causes substantial illness and healthcare demand every year.

In a late-stage clinical study involving more than 40,000 participants, mFlusiva demonstrated stronger protection against influenza than a standard-dose flu vaccine in the 50-to-64 age group. The vaccine also generated stronger antibody responses than a high-dose flu vaccine among older adults, according to reports on the FDA decision.

One potential advantage of mRNA technology is manufacturing flexibility. Unlike traditional flu vaccines that often rely on egg-based production, mRNA platforms can potentially be adapted more rapidly when influenza strains change.

The approval could therefore become an important test of whether mRNA technology can move beyond COVID-19 and establish a broader role in routine infectious-disease prevention.

The vaccine is not expected to have an immediate large commercial impact because of the timing of the U.S. seasonal vaccine contracting cycle. Moderna expects broader commercial opportunities beginning later, while continuing to develop additional products using its mRNA platform.

For healthcare providers and patients, the approval adds another influenza-prevention option for older adults. The decision also gives the pharmaceutical industry a significant demonstration of how mRNA technology can be applied to established vaccine markets.

Researchers and public-health experts will closely monitor real-world effectiveness and safety as the vaccine moves toward broader use.

The FDA decision marks a new chapter in U.S. vaccine development, potentially turning mRNA technology from a pandemic-era innovation into a broader platform for seasonal disease prevention.