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

In a surprising turn of events, the Food and Drug Administration (FDA) has decided to review Moderna's mRNA flu vaccine, previously rejected in a controversial decision. This reversal follows a formal meeting between Moderna and the FDA, where the company proposed modifications to its regulatory approach. Last week, Moderna disclosed that its application had been denied, a decision attributed to Vinay Prasad, a political appointee from the Trump administration who was overseeing vaccine approvals. Reports indicated that Prasad overruled a consensus among agency scientists and a senior career official who supported Moderna's application. Moderna's CEO, Stéphane Bancel, expressed gratitude for the FDA’s constructive engagement, stating, "We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review." The company is optimistic about making its flu vaccine accessible to seniors later this year, pending FDA approval. The FDA is expected to render a verdict on the vaccine by August 5, 2026. Prasad’s initial rejection was reportedly based on the comparison of Moderna's mRNA-1010 vaccine with standard-dose flu vaccines, such as Fluarix from GlaxoSmithKline, used during its Phase 3 trial involving nearly 41,000 adults aged 50 and older. In a letter dated February 3, Prasad criticized the trial design, claiming it did not represent the best available standard of care. Although there had been previous suggestions from FDA scientists to use a high-dose flu vaccine for older participants, the agency ultimately approved the trial's original design. Moderna has since agreed to include a comparison with a high-dose vaccine for some older trial participants and provide the FDA with further analysis.