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COVID Shots for Kids Are Over

Prasad and Makary—neither of whom has formal training in infectious disease or vaccinology—focused primarily on the implications for COVID boosters for young, healthy adults. But experts outside of the agency told me that the policy could also prevent most American children from accessing their initial series of COVID vaccines—essentially guaranteeing that kids will first encounter…

The FDA’s new approach to boosters could mean that kids will no longer be able to get vaccinated against the disease to begin with.By Katherine J. Wu

Long before he joined the FDA to run the center that regulates vaccines, Vinay Prasad argued against COVID shots for kids. Among his many criticisms of the United States’ approach to combatting the disease, Prasad has insisted that pediatric vaccines have few benefits for kids—and has maintained that the FDA should never have authorized COVID boosters for them, that the CDC should never have recommended those shots, and that “it is malpractice for a doctor to recommend the booster to children.” And he has advocated for the CDC removing the COVID vaccine from the childhood-immunization schedule.

Just two weeks into his tenure as the FDA’s new vaccine czar, Prasad seems to be taking the first steps toward turning this rhetoric into reality.

Yesterday, he and Marty Makary, the FDA’s new commissioner, announced a new framework for COVID-19 vaccines: The agency will no longer green-light new formulations of COVID shots for healthy people under 65, unless companies submit data from new clinical trials that prove the shots’ worth—an unusual ask, experts told me, for vaccines that have already been through the sorts of rigorous studies that scrutinize their safety and effectiveness, and received the agency’s authorization or approval.

When describing this shift in an article published in The New England Journal of Medicine, as well as in a livestreamed FDA press conference, Prasad and Makary—neither of whom has formal training in infectious disease or vaccinology—focused primarily on the implications for COVID boosters for young, healthy adults. But experts outside of the agency told me that the policy could also prevent most American children from accessing their initial series of COVID vaccines—essentially guaranteeing that kids will first encounter the virus without protection.

https://www.theatlantic.com/health/archive/2025/05/covid-shots-kids-fda-boosters/682880/

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