The FDA has introduced a new approval strategy for updated coronavirus vaccines focusing on older adults and individuals with high-risk health conditions. This change, announced by FDA leaders in a New England Journal of Medicine article, aims to ensure that vaccines are specifically available to those most vulnerable, estimated to encompass over 100 million Americans. The revised approach requires vaccine makers to perform randomized controlled trials before approval for lower-risk populations, reinforcing the need for robust data while changing the broad recommendation that previously included healthy children and adults.
The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.
Updated vaccines will probably be available in the fall for Americans over the age of 65, as well as those older than 6 months with health conditions.
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