After COVID-19, flu: Moderna wins approval for world’s first mRNA vaccine

Moderna has achieved a dramatic regulatory reversal by securing approval for the world’s first influenza vaccine based on messenger RNA (mRNA) technology.

According to BioPharma Dive on the 6th (local time), the US Food and Drug Administration (FDA) approved Moderna’s mRNA influenza vaccine, mFlusiva, to prevent seasonal influenza in adults aged 50 and older. Its previous code name was mRNA-1010.

The approval includes different conditions based on age. Adults aged 50 to 64 received full approval, while adults aged 65 and older received “accelerated approval” contingent on postmarketing studies. Moderna plans to conduct confirmatory trials over the next two influenza seasons.

Moderna CEO Stéphane Bancel said in a statement, “Influenza remains an important public health challenge, and mFlusiva provides an important new option for older adults in the United States.” He added, “This approval demonstrates the potential of our mRNA platform to address public health challenges through continued scientific innovation.”

Moderna, which became well known for its COVID-19 vaccine, has since sought new growth drivers as revenue declined sharply. mFlusiva was expected to become the company’s next blockbuster, leveraging the advantage of mRNA technology, which can be developed more quickly than conventional vaccines.

However, mFlusiva’s approval process was not smooth. Moderna initially pursued a combined COVID-19 and influenza vaccine but withdrew the plan after the FDA requested additional data. The company then submitted results from a study of the influenza vaccine alone published in the New England Journal of Medicine (NEJM), but the FDA unusually refused to accept the application for review at the time.

The decision drew public backlash, and the FDA reversed its position and resumed the review after an official meeting with Moderna. The situation then changed when an FDA advisory committee unanimously recommended approval of mFlusiva last June.

In clinical results, mFlusiva reduced the likelihood of influenza-like illness by 27% in adults aged 50 and older compared with a standard-dose influenza vaccine. In terms of safety, reactions consistent with those reported for existing mRNA vaccines, including fatigue, arthralgia and myalgia, were reported, and no new serious concerns were identified.

Moderna plans to supply mFlusiva to the US market for the 2026-2027 influenza season. Reviews are also underway in Europe, Canada and Australia.