On May 20, 2025, the FDA revised its COVID-19 vaccination guidelines, limiting approvals to adults aged 65 and over or those with certain health risks, such as chronic conditions. This decision marks a shift from universal vaccination recommendations for all individuals aged 6 months and older. The FDA's approach is driven by declining booster uptake, insufficient evidence supporting the efficacy of repeated boosters in healthy populations, and the prevalence of natural immunity from previous infections. Vaccine manufacturers will need to conduct trials to show safety and benefits for lower-risk groups.
The FDA has announced a new COVID-19 vaccination guideline, approving vaccines only for those over 65 or with specific health risks, moving away from universal recommendations.
FDA Commissioner Makary and Vinay Prasad emphasized that the shift to a risk-based vaccination approach is due to declining booster uptake and evidence regarding natural immunity.
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