The Trump Administration said Tuesday that it will now require randomized clinical trial data for COVID-19 boosters in healthy individuals aged 6 months to 64 years before granting full approval.
The US Food and Drug Administration said in the New England Journal of Medicine that it will continue to approve vaccines for adults over 65 and high-risk individuals using immunogenicity data.
The shift follows poor annual booster uptake over the past two seasons, with less than 25% of Americans participating, and under 10% among children under the age of 12, the FDA said.
The FDA noted its new framework seeks to strike a balance between timely access for vulnerable groups and strong evidence for low-risk populations, requiring postmarketing trials to examine real-world outcomes.
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