FDA Approves First mRNA Flu Vaccine For Older Adults

Aug 06, 2026 01:44 PM - 1 hour ago 1

Topline

The U.S. Food and Drug Administration approved the country’s first mRNA-based flu vaccine for older adults, months aft the regulator faced backlash from aesculapian professionals and scientists for refusing to reappraisal the changeable amid a broader effort by the Robert F. Kennedy Jr. led wellness section to ace down connected mRNA shots.

Moderna said its mFLUSIVA changeable will beryllium disposable for eligible populations for the 2026-2027 flu season.

NurPhoto via Getty Images

Key Facts

In a statement, vaccine shaper Moderna said its “mFLUSIVA” vaccine against seasonal influenza has been approved for usage by each adults aged 50 and older.

The support was based connected a phase 3 trial involving astir 41,000 group aged betwixt 50-64 years, which recovered that the mRNA vaccine is astir 26.6% much effective successful preventing a flu infection compared to older flu shots.

In June, the FDA’s independent vaccine advisory committee unanimously recommended the support of the vaccine for adults aged betwixt 50 and 64.

The FDA has besides granted accelerated support for administering the vaccine to adults who are 65 and older, based connected the panel’s recommendation—which could go a afloat support if follow-up proceedings results are considered favorable.

Moderna said it expects mFLUSIVA to beryllium disposable to eligible populations successful the state for the 2026-2027 flu season.

Crucial Quote

"Flu remains a important nationalist wellness challenge, and mFLUSIVA provides an important caller action for America's seniors. This support besides reflects the ongoing imaginable of our mRNA platform,” Moderna CEO Stéphane Bancel said.

What Do We Know About The FDA’s Earlier Stance?

In February, Moderna announced that the FDA had rejected its petition to reappraisal its mRNA flu vaccine. The drugmaker noted that the FDA’s apical vaccine regulator, Dr. Vinay Prasad, dismissed the company’s exertion complete its prime of the power flu vaccine the mRNA changeable was compared against, which it didn’t see the champion disposable vaccine. Prasad is simply a salient protagonist of Kennedy and has been a professional of the Covid-19 vaccine. After the determination drew backlash, FDA Commissioner Marty Makary walked backmost the decision and said the first refusal was “part of a speech that occurs pinch each supplier makers.”