The FDA reversed an earlier refusal-to-file and agreed to review Moderna’s seasonal mRNA flu vaccine mRNA-1010 after a Type A meeting with the company, setting a PDUFA-style target decision date in August. Moderna proposed an age-stratified regulatory pathway—full approval for ages 50–64 and accelerated approval for adults 65+ with a post‑marketing study in older adults. Moderna framed the outcome as a constructive regulatory engagement; CEO Stéphane Bancel said the company looks forward to making the vaccine available later this year if approved. The agency’s rapid change of stance has drawn scrutiny after media reports that President Trump called FDA leadership about Moderna, a development the White House denied. The episode has highlighted tensions between political actors and regulators and underscored how high-profile vaccine programs can accelerate regulatory interactions. Companies and observers say the case may influence how sponsors design comparator arms and negotiate study-to-submission pathways with CBER going forward.