FDA walks back universal Covid-19 booster policy—but is it enough?
I analyse the FDA’s new policy shift and highlight some critical gaps that remain.
The FDA has announced a policy shift on Covid-19 vaccination, stating it will no longer support universal booster approvals without robust clinical evidence of benefit—particularly for healthy individuals under 65.
A new article in the New England Journal of Medicine by Dr Vinay Prasad, incoming director of FDA’s Center for Biologics Evaluation and Research (CBER), and Dr Marty Makary, FDA Commissioner, outlines a new framework aimed at restoring public trust.
The new approach abandons blanket recommendations in favour of risk-based policies and sets a higher bar for future approvals.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and received six previous doses will benefit from the seventh dose,” they wrote.