US EditionFDA sets new COVID booster guidelines requiring trials for approvals for healthy adults
- The FDA published a new framework on Tuesday requiring large clinical trials before approving tweaked COVID vaccines for healthy adults and children.
- This framework represents the latest development in ongoing efforts to evaluate COVID vaccine usage and prompts reconsideration of expanded vaccine access under previous federal policies.
- The new guidance ends routine annual COVID-19 boosters for healthy younger adults and children, limiting availability to seniors and those with at least one health risk.
- Agency officials indicated that this strategy may continue to provide yearly COVID-19 vaccines to between 100 and 200 million adults, a plan that experts consider a sensible middle ground.
- This policy shift aims to generate data on vaccine benefits for healthier groups before broader approvals and could restrict access for some people this fall.
268 Articles
268 Articles
FDA Makes a Big Shift on COVID Vaccine Policy
The Food and Drug Administration announced a major shift Tuesday on how COVID-19 vaccines will be approved—and it could mean that not everybody who wants a COVID shot this fall will be able to get one. In a paper published in the New England Journal of Medicine , top FDA...
FDA Will No Longer Approve Annual COVID Vaccine For Younger, Healthy Patients - Real News Now
In a major policy shift, the FDA has announced it will no longer approve annual COVID-19 vaccines for healthy children and adults under 65. Going forward, yearly boosters will be reserved primarily for seniors and individuals with underlying health conditions, marking a significant rollback of the universal vaccination approach used during the pandemic. According to FDA officials, the updated guidance reflects evolving data showing that the bene…
FDA Plans to Require Clinical Trials Before Approving Annual COVID Vax Boosters for Healthy People | May 20, 2025
by Natalia Mittelstadt Food and Drug Administration plans to require new clinical trials before approving annual COVID-19 vaccine boosters for healthy Americans under 65 years old. The plan appears in a paper published Tuesday in the New England Journal of Medicine, in which FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s vaccine chief, wrote any new COVID shot must undergo placebo-controlled clinical trials, NBC News reporte…
FDA Plans to Require Clinical Trials Before Approving Annual COVID Vax Boosters for Healthy People | The Star News Network
by Natalia Mittelstadt Food and Drug Administration plans to require new clinical trials before approving annual COVID-19 vaccine boosters for healthy Americans under 65 years old. The plan appears in a paper published Tuesday in the New England Journal of Medicine, in which FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s vaccine chief, wrote any new COVID shot must undergo placebo-controlled clinical trials, NBC News reporte…
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