BALTIMORE, MD—In a surprise move, the US Food and Drug Administration (FDA) will now only recommend COVID-19 vaccines for adults aged 65 and older, as well as individuals at risk of severe illness. This decision marks a significant shift from the current recommendation of annual vaccination for everyone aged six months and older.
The FDA stated that manufacturers will now be required to conduct clinical trials to prove the efficacy of COVID-19 vaccines in healthy children and adults under 65. This decision aligns the US with other high-income nations that have restricted COVID-19 vaccine access to older and more vulnerable populations.
FDA Commissioner Dr. Martin Makary and Dr. Vinay Prasad, Director of the FDA’s Center for Biologics Evaluation and Research, explained their reasoning in an article published in the New England Journal of Medicine. They cited the low uptake of the annual fall COVID-19 booster dose since 2023, particularly among healthy adults and children, as a key factor in their decision.
The announcement comes just two days before the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet. This committee, along with the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), typically collaborate to evaluate evidence before making changes to vaccine policy. Critics have argued that the FDA’s decision to deviate from this process undermines public trust in vaccines.
Makary and Prasad acknowledged the potential for vaccine hesitancy, citing the low uptake of the annual fall COVID-19 booster dose since 2023, at less than 25% and 10% among healthy adults and children, respectively. They emphasized the importance of targeting vaccination efforts towards those most at risk, estimating that their approach, using the CDC’s expansive list of health conditions that increase the risk of severe COVID-19, would allow approximately 100 to 200 million Americans access to vaccines. This represents roughly one-third of the US population.
This article was written with the assistance of AI and reviewed by a human editor.
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