TLDRThe FDA rejected Moderna's application for its mRNA-based flu vaccine, citing issues with the clinical trial comparator. Moderna claims the FDA's reason is inconsistent with previous communications. The vaccine, which uses the same mRNA technology as its Covid shot, was found to be 26.6% more effective than the standard flu shot. The FDA's decision follows Health Secretary Robert F. Kennedy Jr.'s directive for all new vaccines to undergo placebo-controlled clinical trials.

Source: New York Times February 11, 2026 12:50 UTC