FDA To Review Moderna’s Flu Vaccine After Initial Rejection

The U.S. Food and Drug Administration has reversed course and will review Moderna’s new mRNA-based flu vaccine after initially rejecting the application, the company said Wednesday.

Earlier this month, the FDA declined to accept Moderna’s filing, citing concerns that the clinical trial did not include an adequate control group reflecting the best available standard of care.

FDA will now review flu vaccine it had rejected https://t.co/MnXA4k9cHG

— Axios (@axios) February 18, 2026

The agency did not raise safety or effectiveness concerns. Following further discussions, Moderna proposed a revised regulatory plan that the FDA agreed to consider.

Under the updated approach, Moderna is seeking full approval for adults ages 50 to 64 and accelerated approval for those 65 and older, along with a requirement for additional post-marketing studies in seniors. If approved, the vaccine could be available for the 2026–2027 flu season.

The decision comes as the Trump administration continues to emphasize stricter regulatory standards and transparency in federal health agencies. Moderna said it welcomed the FDA’s decision to move forward with a formal review.

Also Read:

When Do We Peak? Science Maps Life’s Performance Curve

An infographic from Information Is Beautiful, drawing on research compiled by Business Insider from multiple scientific studies, shows that different abilities peak at very different ages, from muscle strength in our mid-20s to chess performance in our early 30s, earnings later in midlife, and vocabulary and life satisfaction much later.

tippinsightsTIPP Staff

One In Five Private-Sector Workers Now In Health Or Education

Employment in healthcare and education has steadily expanded for decades, rising from about 1 in 20 private-sector jobs in the 1950s to roughly 1 in 5 today, highlighting how services now dominate U.S. job growth.

tippinsightsTIPP Staff

How Medicaid Work Requirements May Shrink Coverage By Millions

New Medicaid work requirements set to begin in January 2027 could disproportionately affect Americans ages 50 to 64, particularly women, according to KFF Health News. Under the GOP-backed budget law signed during President Donald Trump’s administration, roughly 20 million low-income adults in 42 states and Washington, D.C., must

tippinsightsTIPP Staff