US EditionNew FDA restrictions will make COVID-19 vaccines only available to elderly and people with medical conditions
- The FDA announced on Tuesday that this fall, COVID-19 vaccine authorization in the US will be limited to seniors above 65 and individuals with specific high-risk health conditions.
- This decision follows concerns about limited evidence for booster benefits in healthy younger adults, requiring new randomized placebo-controlled trials before approval for those groups.
- The new FDA policy departs from the previous universal annual shots recommendation and aligns the US with other high-income countries using risk-based vaccine guidelines.
- FDA officials Vinay Prasad and Marty Makary explained that the agency plans to authorize COVID-19 vaccines for older adults and individuals with certain medical conditions based on antibody response data, while requiring more extensive clinical trial evidence before approving the vaccines for healthier, lower-risk populations. They described this strategy as the most stringent globally.
- The policy could reduce vaccine availability for millions of healthy Americans and affect insurance coverage, but it aims to focus protection on vulnerable groups and restore public trust in vaccination.
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Older adults will continue to receive yearly COVID-19 shots, but lower-risk groups will not, says the FDA. dusanpetkovic via iStock / Getty Images PlusOn May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcom…
FDA Reshapes Covid Booster Program, Aiming It at the Most Vulnerable
The FDA is preserving Covid boosters, directing them toward the most vulnerable: the chronically ill, elderly, sick infants, and pregnant women. ... The post FDA Reshapes Covid Booster Program, Aiming It at the Most Vulnerable appeared first on The New American.
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FDA Limits COVID-19 Boosters to Seniors, Other High-Risk Groups
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