FDA Approves Updated Covid Vaccines With New Restrictions

2 weeks ago 11

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The agency’s fall recommendations underscore the goals of Health Secretary Robert F. Kennedy Jr. to limit access to the vaccines, which he has long opposed.

Two boxes of Covid booster vaccine on a blank white background.
The new shots are broadly authorized for people who are 65 and older, but designated for people younger than 65 with a condition that puts them at risk for severe disease.Credit...Pfizer

Christina JewettJacey Fortin

Aug. 27, 2025Updated 1:23 p.m. ET

The Food and Drug Administration on Wednesday approved updated Covid vaccines for the fall season that limit who can get the shots, the federal government’s most restrictive policy since the vaccines became available.

The agency authorized the vaccines for people who are 65 and older, who are known to be more vulnerable to severe illness from Covid. Younger people would only be eligible if they have at least one underlying medical condition that put them at risk for severe disease. Healthy children under 18 could still receive the shots if a medical provider is consulted.

People seeking the shots will soon face another hurdle. An influential advisory committee to the Centers for Disease Control and Prevention must vote to recommend them. But that panel’s makeup shifted when Health Secretary Robert F. Kennedy Jr. unseated existing members, reduced the panel’s size and added some Covid vaccine opponents.

This would mark the first fall/winter season that Covid shots were not widely recommended to most people and children, pitting federal health officials in the Trump administration against several national medical groups that oppose the restrictions.

In a social media post, Mr. Kennedy said the approvals accomplished the goals of keeping vaccines available to people who want them and of demanding that companies conduct placebo-controlled trials. One new, required study would examine “post-Covid-19 vaccination syndrome” in patients, a condition that has been noted in at least one small preliminary medical report, but is still a matter of pitched debate.

“The American people demanded science, safety and common sense,” Mr. Kennedy’s post on X said. “This framework delivers all three.”


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