FDA Rejection of Moderna’s mRNA Flu Vaccine Review

I am writing to express deep concern over the FDA’s recent decision to reject consideration of Moderna’s new mRNA-based influenza vaccine on the grounds of alleged inadequate testing—despite the agency’s earlier agreement that the proposed testing protocols met its standards. This reversal not only undermines trust in regulatory consistency but also risks delaying access to potentially more effective flu prevention tools for millions of Americans. The Department of Health and Human Services (HHS) and, by extension, the FDA appear to be exhibiting an anti–mRNA bias that runs counter to sound science. By dismissing further review of the Moderna flu vaccine, the agency is disregarding the chief advantage of mRNA technology—its capacity for rapid adaptation. Unlike conventional flu vaccines, mRNA formulations can be updated in real time to match the strains actually circulating each season, significantly improving effectiveness. The anti–mRNA bias could have far-reaching public health consequences beyond influenza. The same mRNA platform holds promise in developing therapeutic vaccines for cancer and other serious diseases. Allowing prejudice or political hesitation to cloud scientific evaluation threatens to stall innovation and deprive patients of life-saving treatments. Congress must conduct oversight hearings into this matter to ensure that the FDA’s decisions are guided strictly by science, transparency, and consistency—not by institutional bias or outdated skepticism toward new technology. The American public deserves access to the safest and most effective vaccines available, regardless of platform or politics.