The Food and Drug Administration will no longer approve COVID-19 booster shots for healthy adults and children without new clinical trials proving they are safe and effective.
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, who heads the agency’s center on vaccines, published an article in the New England Journal of Medicine on Tuesday outlining that the agency will require randomized controlled clinical trials before it approves updated immunizations each season for those between 6 months and 64 years old.
COVID-19 booster vaccines for adults over 65 and those at high risk of developing severe symptoms will not require such extensive studies.
“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,” the article reads. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”
Drugmakers can typically introduce new formulas for seasonal vaccines, such as influenza, created to match current circulating mutations based on simple testing to determine if the product generates an immune response.
In their article published Tuesday, Makary and Prasad wrote that COVID-19 is different from influenza and should not receive the same expedited approval process because the SARS-CoV-2 virus evolves differently.
The pair also wrote that the summer surges of COVID-19 can “facilitate the conduct of randomized studies that continue to apply in future time periods.”
Prasad, tapped earlier this month to lead the Center for Biologics Evaluation and Research, has long advocated clinical trials for COVID-19 booster vaccines.
A week before his appointment, Prasad wrote that COVID-19 booster shot uptake has been low in the United States because “the American people have shown they are unwilling to get an unproven annual booster.”
According to the Centers for Disease Control and Prevention, about 23% of adults over 18 report receiving the 2024-2025 COVID-19 vaccine. Only 13% of children were reported to have the 2024-2025 booster.
Makary and Prasad said that a better understanding of how the vaccine affects those at low risk of developing severe disease or who have naturally acquired immunity is needed.
“We simply don’t know whether a healthy 52-year-old woman with a normal [body mass index] who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” wrote the pair.
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The FDA officials estimated that between 100 and 200 million Americans will have access to COVID-19 booster vaccinations because they have a condition that puts them at high risk of severe disease.
The article lists 23 different conditions, ranging from HIV to smoking and physical inactivity, that could make a patient eligible to receive a COVID-19 booster vaccine that has not undergone clinical trials.
