The US Food and Drug Administration (FDA) refused to review Moderna’s application for a new mRNA-based flu vaccine, despite earlier signals that the project could move forward. The agency said the application lacked sufficiently “adequate and well-controlled” clinical trial evidence. The agency’s refusal centered on the study’s design, arguing that it compared the new shot to standard flu vaccines rather than the high-dose versions specifically recommended for seniors.
Date: February 11, 2026. Summary: theguardian.com