FDA significantly reduces age recommendations for COVID-19 vaccine

The U.S. Food and Drug Administration announced this week that it will only recommend COVID-19 vaccines for adults 65 and older and people at risk for severe illness (Source: “FDA significantly limits COVID-19 vaccine recommendations,” CIDRAP, May 20).
 
In a marked departure from the current recommendations of seasonal vaccination for anyone 6 months and older, the FDA will require manufacturers to conduct clinical trials demonstrating the efficacy of COVID-19 vaccines for healthy children and adults under age 65.

Writing in the New England Journal of Medicine, FDA Commissioner Martin Makary and Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, said the move aligns the United States with other high-income nations that have limited vaccine access to older and vulnerable populations.
 
The authors also noted that their approach uses an expansive list from the CDC of health conditions that increase the risk of severe COVID-19, including obesity, depression, asthma, pregnancy, and cardiovascular disease.
 
The authors said COVID-19 is different from influenza, which requires seasonal boosting, in several ways, most notably because natural immunity from previous COVID-19 infections against severe disease appears robust.