FDA and Vaccines

FDA Commissioner Martin Makary told NPR on Dec. 15, 2025 that rebuilding trust requires more humility and transparency, acknowledging a recent FDA memo citing rare reports of pediatric deaths temporally linked to COVID‑19 vaccination and criticizing overly absolute recommendations when evidence is limited. He also said the FDA declined to approve an mRNA‑based flu shot after late‑stage trials showed no benefit and urged flexible, risk‑based approaches to vaccine guidance.