Also known as: mRNA flu shot, mRNA flu vaccine
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
The FDA reversed its initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Moderna reported Q4 revenues of $678 million, down 29.8% year-over-year but beating analyst expectations. The FDA reversed course and will review the company's mRNA flu vaccine application.
Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will depart the agency by the end of April to return to an academic role at the University of California San Francisco.
Health Secretary Robert F. Kennedy Jr. is drawing criticism from anti-vaccine supporters who believe he has not gone far enough in dismantling vaccine programs, following regulatory reversals including the restoration of an mRNA flu shot review.
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
