FDA does U-turn, will review Moderna's mRNA flu shot after shocking rejection

About-face FDA does U-turn, will review Moderna’s mRNA flu shot after shocking rejection Trump admin’s vaccine chief overruled FDA scientists to initially reject the shot. Beth Mole – Feb 18, 2026 12:08 pm | 6 Credit: Getty | Congressional Quarterly Credit: Getty | Congressional Quarterly Text settings Story text Size Small Standard Large Width * Standard Wide Links Standard Orange * Subscribers only Learn more Minimize to nav The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval. The refusal was revealed last week in a sharply worded press release from Moderna. Subsequent reporting found that the decision was made by political appointee Vinay Prasad, the Trump administration’s top vaccine regulator, who overruled a team of agency scientists and a top career official in rejecting Moderna’s application. In an announcement Wednesday morning, Moderna said the FDA has now agreed to review its vaccine after the company held a formal (Type A) meeting with the FDA and proposed a change to the regulatory pathways used in the application. “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stéphane Bancel, Moderna’s CEO, said in the announcement. “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.” The agency is expected to provide a decision on the vaccine by August 5, 2026. Prasad’s ostensible reason for initially refusing to review the application was based not on Moderna’s vaccine, mRNA-1010, but on the established flu vaccine Moderna used for comparison in its Phase 3 trial. Moderna used licensed standard-dose influenza vaccines, including Fluarix, made by GlaxoSmithKline, in the trial, which involved nearly 41,000 adults aged 50 and older. In a letter to Moderna dated February 3, Prasad said this choice “does not reflect the best-available standard of care,” and therefore the trial was not “adequate and well-controlled.” Moderna acknowledged that FDA scientists had previously suggested that the company use a recommended high-dose flu vaccine in trial participants 65 and older. But the agency ultimately signed off on the trial design with the uniform standard dose, calling it “acceptable.” Moderna, meanwhile, agreed to add a comparison of a high-dose vaccine to some older participants and provide the FDA with additional analysis. Anti-vaccine agenda Agency insiders told reporters that a team of career scientists was ready to review the vaccine and held an hour-long meeting with Prasad to present the reasons for moving forward with the review. David Kaslow, a top career official responsible for reviewing vaccines, also wrote a memo detailing why the review should proceed. Prasad rejected the vaccine application anyway. According to today’s announcement, the FDA reversed that rejection when Moderna proposed splitting the application, seeking full approval for the vaccine’s use in people aged 50 to 64 and an accelerated approval for use in people 65 and up. That latter regulatory pathway means Moderna will have to conduct an additional trial in that age group to confirm its effectiveness after it’s on the market. Andrew Nixon, spokesperson for the US Department of Health and Human Services, confirmed the reversal to Ars Technica. “Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Nixon said in a statement. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.” The FDA typically takes a levelheaded approach to working with companies, rarely making surprising decisions or rejecting applications outright. While Prasad claimed the rejection was due to the control vaccine, the move aligns with the more extensive anti-vaccine agenda by anti-vaccine Health Secretary Robert F. Kennedy Jr. Kennedy and the allies he has installed in federal positions are particularly hostile to mRNA technology. Moderna alone has already lost more than $700 million in federal contracts to develop pandemic vaccines. Next month, Kennedy’s MAHA Institute is hosting an anti-vaccine event that alleges there’s a “massive epidemic of vaccine injury.” The event description claims without evidence that use of mRNA vaccines is linked to “rising rates of acute and chronic illness.” Vaccine makers and industry investors, meanwhile, are reporting that Kennedy’s relentless anti-vaccine efforts are chilling the entire industry, with companies abandoning research and cutting jobs. In comments to The New York Times, Moderna’s president, Stephen Hoge, said, “There will be less invention, investment, and innovation in vaccines generally, across all the companies.” Beth Mole Senior Health Reporter Beth Mole Senior Health Reporter Beth is Ars Technica’s Senior Healt