BioCentury
ARTICLE | Politics, Policy & Law

Learning from FDA’s Moderna U-turn

The White House grabbed the steering wheel this time, but Commissioner Makary and CBER Director Prasad are still driving the car

February 20, 2026 10:29 PM UTC

FDA’s U-turn on Moderna’s mRNA-based flu vaccine has prompted two questions in biopharma boardrooms: what led to the reversal, and does it offer a replicable strategy for modifying or preempting adverse FDA decisions?

The short answers are “politics” and “no.”...