Moderna’s mRNA Flu Vaccine Back Under FDA Review
THURSDAY, Feb. 19, 2026 (HealthDay News) — In a sudden reversal, the U.S. Food and Drug Administration (FDA) has agreed to review Moderna’s experimental mRNA influenza vaccine.
The move comes just one week after the agency refused to evaluate the company’s application, a decision that sent shockwaves through the biotech industry.
The initial rejection centered on the design of Moderna’s clinical trials.
Regulators had previously argued that the company should have tested its shot against a higher-strength flu vaccine for the older adults in the trial’s control group.
Following the rejection, Moderna modified its approach to satisfy the government’s concerns.
Full Article