FDA to limit covid shot approval to elderly, those with medical conditions

The FDA plans to limit approval of updated "coronavirus vaccines" to older adults and high-risk individuals, marking a significant change.

Vaccines are expected to be available this fall for those over 65 and individuals over 6 months with conditions like asthma, diabetes, and obesity. About 100 million Americans could be eligible under the new guidelines.

Vaccine makers must conduct randomized trials for healthy people aged 6 months to 64 years before approval. FDA leaders, including Commissioner Marty Makary, emphasized, “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”

Health experts support the revised focus on high-risk groups. Concerns over testing vaccine safety have also been raised, potentially affecting availability.

U.S. regulators say annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved.

Companies that want to market their vaccines to those Americans will need to conduct large, new studies.