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By Gabe Whisnant
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The Trump administration has introduced a major policy change that will restrict routine access to annual COVID-19 vaccinations for healthy children and younger adults.
Announced Tuesday, the new framework, published in the New England Journal of Medicine, outlines the Food and Drug Administration's (FDA) intent to limit streamlined vaccine access to adults 65 and older, as well as younger individuals with underlying medical conditions that elevate their risk for severe COVID-19.
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Why It Matters
This marks a shift from earlier policies that broadly encouraged yearly COVID shots for nearly all age groups.
While some celebrated the changes in recommendations, Make America Healthy Again (MAHA) influencer Diana Atieh was disappointed with the decision, as the vaccine is still recommended for other groups.
"It's really unfortunate to see the Trump administration and FDA approve and push the COVID vaccine, especially to those who already have preexisting health conditions," Atieh told Newsweek on Tuesday.
What to Know
FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad authored the framework, which calls on vaccine manufacturers to conduct large, months-long clinical trials for new COVID-19 vaccine updates if they are intended for use in healthy, low-risk populations.
Under the new guidance, annual shots could still be available to an estimated 100 to 200 million people, though those outside of high-risk categories may face limited access. For them, the availability of the fall booster could depend on individual providers or insurance coverage.
The policy shift comes amid growing scrutiny of COVID-19 vaccine policies and precedes the first meeting of FDA's outside vaccine advisory panel under the Trump administration. It also echoes last week's FDA decision to approve Novavax's COVID vaccine but with strict limits on who can receive it—restrictions that came after Trump appointees overruled FDA scientists' recommendation for broader access.
Makary and Prasad criticized the previous "one-size-fits-all" model for COVID vaccination, noting that the U.S. has been "the most aggressive" among developed nations in recommending boosters. They questioned the utility of additional doses for healthy individuals with past infections and prior vaccinations.
The FDA's decision raises procedural questions as well. Experts note that publishing new guidance in a medical journal before undergoing the traditional draft-and-comment process could violate federal norms.
It also risks preempting the role of the Centers for Disease Control and Prevention (CDC), whose advisory committee is expected to debate group-specific vaccine recommendations soon.
Dr. Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, noted that while studies have shown booster shots reduce mild and moderate illness for up to six months, even in healthy people, the FDA appears to be narrowing access prematurely.
What People Are Saying
FDA officials wrote: "We simply don't know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses... will benefit from the seventh dose."
Offit asked, in remarks to the Associated Press: "Is the pharmacist going to determine if you're in a high-risk group? The only thing that can come of this will make vaccines less insurable and less available."
Georgia Representative Marjorie Taylor Greene told Newsweek: "I'm thrilled with the FDA's new guidelines for COVID vaccines! No one should have ever been forced to take an unproven and experimental shot. It turned out deadly with miscarriages and myocarditis going through the roof after the COVID shot was forced upon the American people.
"Thank you to Secretary Kennedy for rightly updating the FDA's guidance. Big Pharma has made enough money off the government's recommendations. It's time for the American people to have health freedom again."
Atieh told Newsweek: "While I still have high hopes of [Health and Human Services Secretary Robert F. Kennedy, Jr.] stepping in and changing the system to highlight risks associated with vaccines, here is a prime example of just how influential Big Pharma still is," she said.
"It's very important for the FDA to also show the risks with any medical procedure like vaccinations, and here they have not done that—which shows how little they care about informed consent for consumers."
What's Next
The framework suggests that future vaccine approvals for healthy individuals will require placebo-controlled studies, particularly to measure the shot's impact on severe illness, hospitalization, and death.
This article contains reporting by The Associated Press.
Update: 5/20/25, 2:43 p.m. ET: This article has been updated with additional information and remarks.
Update: 5/20/25, 2:43 p.m. ET: This article has been updated with additional information and remarks.
Update: 5/20/25, 7:54 p.m. ET: This article has been updated with additional information and remarks.
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