New FDA framework on Covid vaccines leaves pediatricians confused and concerned
A new FDA framework for Covid-19 vaccines created confusion among physicians about what it means for young children
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 livestream on YouTube — created confusion among physicians about what it means for young children. While much of the language discussed the need for more data supporting the ongoing use of annual booster shots, it also referred to a lack of evidence for children as young as 6 months, who currently get a two- or three-dose “primary” series of vaccinations.
