New FDA framework on Covid vaccines leaves pediatricians confused and concerned
STAT
MAY 20, 2025
A new framework for Covid-19 vaccines announced by Food and Drug Administration leaders Tuesday suggests the agency will no longer approve new Covid vaccines for healthy individuals under 65, including babies, without data from new randomized clinical trials showing their benefit. The plan — described in a commentary in the New England Journal of Medicine, followed by a live stream on YouTube — created confusion among physicians about what it means for young children.
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