In a significant turnaround, the U.S. Food and Drug Administration (FDA) has agreed to review Moderna's application for its new mRNA-based flu vaccine after initially rejecting it due to concerns over the adequacy of its clinical trial. This decision follows a U-turn by the Trump administration, which reversed its earlier move to block the trial after facing backlash from Moderna and the U.S. biotech industry. The FDA's decision comes after a 'constructive' meeting with Moderna, where the company proposed a revised approval pathway focusing on older adults. The application now seeks full approval for individuals aged 50 to 64 and accelerated approval for those 65 and older, with a commitment to conduct an additional study post-market. Moderna's CEO, Stephane Bancel, expressed optimism, stating, 'Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu,' as reported by the Tribune Latest on February 18, 2026.
HEALTH
US FDA Agrees to Review Moderna's New mRNA Flu Shot

The FDA will review Moderna's mRNA flu vaccine application after a prior rejection, aiming for approval for seniors. This follows industry backlash and reflects ongoing vaccine safety debates.
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