This article originally appeared on Jon Fleetwood’s Substack and was republished with permission.
Guest post by Jon Fleetwood
Food and Drug Administration (FDA) Commissioner Dr. Marty Makary on Monday penned an opinion piece in The Wall Street Journal titled “Why the FDA Doesn’t Support Covid Boosters Forever.”
In it, Dr. Makary confirmed a major policy shift: COVID shots are no longer approved for the general healthy population, and mandates are effectively dead.
The piece was published the same day Trump questioned whether Operation Warp Speed was “as brilliant as many say it was” and demanded Big Pharma release withheld COVID-19 data.
Risk-Tiered Approach
Makary noted that the FDA approved the latest COVID vaccines only for adults over 65 and for those six months and older with one or more risk factors for severe COVID.
This mirrors Europe, where France restricts shots to people over 80 and the U.K. to those over 75.
“This regulatory framework brings the U.S. in line with peer nations,” Makary wrote, signaling a decisive break from the booster-for-all strategy that dominated the Biden years.
FDA Admits: No Evidence of Benefit for the Healthy
Most striking was Makary’s admission that the FDA lacks confidence that repeat Covid shots benefit healthy people.
“Currently, we don’t have that confidence for, say, a seventh Covid shot for [a] healthy 12-year-old girl who recently recovered from Covid,” he wrote.
In other words: the agency cannot say the benefits outweigh the risks for healthy individuals.
Clinical Trials Ordered—True Placebo Controls
Makary revealed that as part of its new approvals, the FDA is demanding that all vaccine companies run randomized clinical trials to determine whether COIVD shots improve outcomes in healthy people.
These studies will, for the first time, use a true placebo (salt water).
They will also monitor whether the spike protein—the molecule produced by the shots—persists in the body, something multiple studies have already observed and which many experts suspect contributes to post-vaccine injuries.
“The FDA’s mandate is to compel companies to generate evidence to answer questions Americans have,” Makary wrote.
No Proof of Transmission, Attendance, or Long Covid Claims
Makary dismantled other justifications long used to promote shots:
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No proof of preventing transmission: “No company has ever submitted data to the FDA to prove that Covid shots, which do not halt transmission, prevent caregivers from infecting vulnerable people.”
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No proof of reducing absenteeism: Claims that the shots keep kids in school or adults at work have never been supported by data.
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No proof on long Covid: “Again, the FDA has no data to support this claim and has never allowed manufacturers to make it,” Makary admitted.
The FDA is now requiring companies to actually measure long COVID symptoms in upcoming studies.
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Mandates Officially Over
Makary declared that mandates were “contentious, and ultimately a policy error,” forcing “hundreds of thousands of people out of work, without clear evidence of helping the public.”
With the new framework excluding the healthy school-age and working population, college and school mandates are now legally impossible.
The FDA is also revoking the emergency-use authorization (EUA) for COVID vaccines—an authority that underpinned nationwide mandates.
“The emergency is over,” Makary wrote plainly. “[A]nd the U.S. is joining other nations in shifting to a risk-tiered approach on vaccines.”
Bottom Line
For the first time, the FDA is openly acknowledging what millions of Americans have long suspected: there is no clear evidence COVID shots benefit healthy people, and the government can no longer justify forcing them on the population.
Instead of rubber-stamping new boosters, the FDA is demanding randomized placebo-controlled trials and spike protein persistence studies.
Mandates are finished, EUAs revoked, and the U.S. is moving to a risk-based framework aligned with Europe.
Makary admits the truth: “No one knows how many shots a healthy person should get in his natural life, or if a healthy person who already had Covid benefits from a seasonal dose.”
The booster-for-all era is officially over.
Copyright 2025 Jon Fleetwood
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