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FDA Commissioner Outlines Age‑stratified COVID‑booster Framework, Calls for Company Trials

3616400 · May 22, 2025
AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.

Summary

Dr. McCary described an age‑stratified framework for future COVID‑19 boosters that would limit routine boosters for healthy younger people absent new trial data, and said FDA published a framework in the New England Journal of Medicine to provide predictability for developers.

Dr. McCary, the Food and Drug Administration commissioner, told senators that the agency published a framework in the New England Journal of Medicine proposing an age‑stratified approach to future COVID‑19 booster authorizations.

"We've been suspending that role for the last 4 years with COVID boosters," Dr. McCary said, explaining the agency now expects clinical trial data for boosters aimed at younger, healthy…

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