FDA 'Doesn't Support COVID Boosters Forever'—Demands Proof COVID Shots Benefit the Healthy
FDA Commissioner Dr. Marty Makary says the "emergency is over, and the U.S. is joining other nations in shifting to a risk-tiered approach on vaccines."
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.
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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:
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.”
No proof of reducing absenteeism: Claims that the shots keep kids in school or adults at work have never been supported by data.
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.
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.
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What do these people not understand. The COVID shot is a death shot. The last people that should ever get this shot are the elderly and children with a risk factor. How does this make sense to any sane person with half a brain cell. The shots are DEADLY and need to be BANNED along with ALL mRNA shots. They keep throwing us bones and expect us to think they are doing great things. Or is it that they think we are so stupid as to think they are actually addressing the issues. The shots are DEATH shots and there is nothing more to understand and they KNOW they are death shots. THEY KNOW!!!
Who is supposed to participate in these future RCTs?
No COVID “unvaxxed” person is going to sign up…so the “control” group, even if they receive true inert placebos in these future RCTs will all be previously mRNA gene "therapy" injected people (once again, safety could be confounded with harms, this time due to exposure to prior mRNA transfection injections).
For anyone who still believes that the COVID shots were in any way beneficial to anyone, you have sadly been tragically misinformed.
The mRNA shots were/are always going to be an immunological catastrophe for humanity.
The mechanism of action (using mRNA instructions to turn one’s own cells into foreign non-self “spike protein factories”) is the primary mechanism of harm.
The primary danger of the COVID-19 mRNA injections has always been one’s own immune system’s attack response by the mighty CD8+ Cytotoxic T Lymphocyte cells (AKA Killer T-cells):
The COVID-19 mRNA injections must be recalled from the market and mRNA-based products must be banned because the modified mRNA-LNP genetic technology platform is fundamentally flawed & dangerous by design.
These modified mRNA-LNP COVID-19 injections, that trigger one's own immune system to attack & kill one's own formerly healthy cells (that have been instructed to produce/express foreign, non-self proteins), no matter where those cells are in the body, never should have been made available to the public in the first place.
When the (designed to be long-lasting) n1-methyl pseudouridine modified mRNA transfects one's cells, and gives instructions for the ribosomes to make & express foreign non-self proteins (such as the toxic SARS-CoV-2 spike protein), one's immune system sends the CD8+ cytotoxic T lymphocytes (CTLs) to kill those formerly healthy cells that are now making & expressing non-self proteins.
It is the mission of these CD8+ CTLs to seek out and destroy any such transfected cell that is making foreign non-self proteins. That’s what they do…
Due to the biodistribution properties of the lipid nanoparticles, the encased modified mRNA can go anywhere in the body, including crossing the blood-brain and placental barriers...The LNP "delivery vehicles" traveled to different parts of the body in different people.
Expressing any foreign protein is fatal to the cell doing the expressing. The reason is, our bodies are protected by being able to distinguish ourselves from things that shouldn't be there. Anything non-self will trigger immune destruction of the cells & tissues involved.
Some people will express lots of foreign proteins in vulnerable locations. Others express less in less vulnerable areas.
The location of expression defines the adverse event: if you get foreign protein expression in your heart cells, you could get myocarditis & experience cardiac arrest; if the expression is in your brain, spinal cord, or peripheral nervous system, you could get one or more of a variety of neurological conditions; if in your eye, possible blindness; if in your ovaries, possible infertility; if in the placenta, possible miscarriage, stillbirth, or birth defects; if in the endothelial cells that line your blood vessels, possible vascular &/or microvascular injuries like clots/microclots or the long white fibrous clots, leading to strokes, heart attacks, or pulmonary embolisms…
If the expression of foreign proteins is in your own immune cells, you could experience immune dysfunction, dysregulation, & suppression including repeated infections, immune tolerance of a pathogenic foreign protein due to antibody subclass switch to IgG4 & increased IgG4-related diseases, T cell exhaustion, interference with & suppression of innate immunity, persistent systemic inflammation, dysregulation of toll-like receptors and reduced cancer surveillance or the suppression of tumor-suppressing immune system activities & cell-signaling (increasing your risk of fast-growing and aggressive cancers)…
And more…
There's no limit to the horrible consequences of injecting into your body something that triggers your own immune system to attack & kill your own formerly healthy cells & tissues.
The public “health” agencies, the COVID “authorities”, & the “mainstream” media fraudulently marketed these experimental mRNA gene “therapy” products as “safe & effective vaccines”. Trusting people thought that they were being presented with the choice (or the mandate) as to whether or not to take a “safe & effective vaccine”…But that was/is a deceptively false “choice”…
The COVID-19 mRNA injections are NOT safe, they are NOT effective, and they are NOT vaccines.
These modified mRNA-LNP gene “therapy” injections never would have passed proper safety studies required for gene therapy products. Safety studies (including biodistribution, immunogenicity, immunotoxicity, genotoxicity, carcinogenicity, reproductive toxicity, shedding, long-term effects, & more) that were bypassed because of the fraudulent mislabeling as “vaccines”. (And because of the EUA & “countermeasure” designations under the Project BioShield Act & PREP Act).
NO ONE should have ever had the “choice” of taking these gene “therapy” injections because the modified mRNA-LNP genetic technology platform is fundamentally flawed & dangerous by design.
The danger is NOT limited to just getting more COVID “boosters”. ANY mRNA gene “therapy” product that transfects your cells and instructs those cells to produce foreign non-self proteins (ANY non-self protein) will trigger an immune system attack response against your own cells & tissues (the role of the Killer T-cells is to monitor ALL the cells of the body, ready to destroy/kill any that express foreign, non-self proteins). This makes EVERY mRNA-based injected product harmful by design.
No one who took these modified mRNA-LNP COVID injections made an informed decision. Most people had no clue about what they allowed to be injected into their bodies...
Also most people still do not understand that the devastating harms inflicted upon people over the last few years was intentional:
https://rumble.com/v6qcb0y-dr.-david-martin-mar-06-2025-edmonton-alberta-replay.html