US EditionNew FDA restrictions will make COVID-19 vaccines only available to elderly and people with medical conditions
- The FDA unveiled a new policy on Tuesday to limit routine annual COVID-19 vaccinations to adults 65 and older and those with high-risk medical conditions.
- This change follows concerns that prior one-size-fits-all vaccine recommendations lacked sufficient data on benefits for healthy younger adults and children.
- The FDA outlined new guidelines in a recent publication that require comprehensive clinical trials for vaccine modifications before they can be approved for healthy individuals, while maintaining expedited approval processes for seniors and those at higher risk.
- Officials estimate this approach may keep annual vaccines available to 100 million to 200 million Americans, while expert Dr. Paul Offit noted the guidance could reduce vaccine access and questioned its impact on advisory panels.
- The policy change prompts concerns about the broader availability of COVID-19 vaccines this fall and reflects increased oversight by the current administration, highlighting the importance of gathering more data to confirm benefits across the general population.
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The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
NEW – FDA orders Pfizer, Moderna to update COVID mRNA vaccine warnings, adding heart injury risk, mainly in teen boys and young men — CBS
NEW – FDA orders Pfizer, Moderna to update COVID mRNA vaccine warnings, adding heart injury risk, mainly in teen boys and young men — CBS — Disclose.tv (@disclosetv) May 21, 2025
FDA will approve COVID-19 vaccine only for older adults and high-risk groups – a public health expert explains the new rules
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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