The Deception of the FDA’s New COVID-19 Vaccine Guidance
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The Great ‘MAHA’ Divide
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On May 20, two top Trump administration officials in the US Food and Drug Administration (FDA) published an article in the New England Journal of Medicine (NEJM) titled “An Evidence-Based Approach to Covid-19 Vaccination”.
The article proposed new FDA guidance for the pharmaceutical industry characterized as a dramatic shift in the FDA’s approach to regulating COVID‑19 vaccines.
It indicated a move away from the FDA’s rubber-stamping of these vaccines, we were told, and toward “evidence-based” policymaking.
The authors were Dr. Vinay Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), which is responsible for the vaccine approval process; and Dr. Martin (“Marty”) Makary, the FDA Commissioner.
Prior to joining the FDA, both men were vocal critics of the COVID‑19 vaccine recommendations made by the Centers for Disease Control and Prevention (CDC).
They were not otherwise known, however, for seriously questioning the CDC’s routine childhood vaccine schedule like everyone in the health freedom movement.
The FDA is a subagency of the Department of Health and Human Services (HHS), which is headed now by Secretary Robert F. Kennedy, Jr., a longtime critic of so-called “public health” policies who joined with “warrior moms” to found the organization Children’s Health Defense (CHD) to address the threat to children’s health from the incessant onslaught of environmental toxins—including from the CDC’s vaccine schedule.
Mr. Kennedy is now in the position of serving under the proud executor of “Operation Warp Speed”, the taxpayer-funded project to rapidly develop and distribute COVID‑19 vaccines—the stated endgame of the lockdown madness.
Kennedy had been an independent candidate for president until he quit his campaign to join forces with Donald Trump—despite Kennedy having promised his campaign supporters that “UNDER NO CIRCUMSTANCES” would he do that.
At that point, Kennedy rebranded his political campaign “MAHA”—Make America Healthy Again. It was a play on Trump’s “Make America Great Again” brand, “MAGA”.
The campaign website “TeamKennedy.com” was redirected to “MAHAnow.org”, where members of the health freedom movement were encouraged to help make America healthy again by joining the “MAHA Movement”—which meant by voting for Trump.
“A Vote for Trump Is a Vote for Kennedy”, a banner at the top of the campaign’s website proclaimed.
And members of the health freedom movement lined up in droves to do so. Senior aides in the White House told Politico they believed this alliance was a decisive factor in the November 2024 presidential election.
Since then, the acronym “MAHA” has been used as a euphemism for “the health freedom movement” despite the obvious logical distinction between a grassroots movement and a political campaign.
That distinction has been increasingly forcing itself into the public discourse.
In particular, the controversy over Trump’s nomination of tech entrepreneur Casey Means for the position of Surgeon General has revealed a deep and growing divide within the health freedom movement.
In one group are those who supported Trump from the start or who were so adamantly loyal to Kennedy that they voted for Trump even if only to get Kennedy into a government position, who believe that any perceived lack of significant change is just because Kennedy has to “play the game” of politics, and who insist that we should “trust” his behind-the-scenes plan to get the job done.
In the other group are those who refuse to compromise when it comes to our children’s health, who see recent developments as mere public relations stunts instead of meaningful change, and who do not withhold criticisms of the Trump administration and of Kennedy for what they perceive as his new role of giving his own stamp of approval to the continuation of criminal policies.
At the top of the list of those policies, as agreed by everyone in the grassroots movement, is the FDA’s rubber-stamping of and the CDC’s recommendations for COVID‑19 vaccines—including for infants and pregnant women.
On May 21, the day after the FDA officials’ article was published in the New England Journal of Medicine, Secretary Kennedy hailed it as “a long-overdue return to scientific integrity and medical freedom”— proof that “[the FDA] is finally breaking away from the one-size-fits-all vaccine policy that authorized the COVID shots for every American over 6 months old.”
Many in the MAHA movement have interpreted the article as an announcement of the intent by FDA officials to require COVID‑19 vaccine manufacturers to conduct randomized, placebo-controlled trials to receive continued authorizations or approvals for their products for use in healthy and non-elderly people.
It’s been hailed as a great victory of evidence-based policymaking over the previously prevailing rubber stamping of pharmaceutical products—a clear proof that things are heading in the right direction now that Mr. Kennedy is HHS Secretary under President Trump.
But is it really a victory for health freedom? Or is it just a public relations ploy from the administration that executed “Operation Warp Speed” that aims to disarm longtime critics of public vaccine policies?
Between these two opposing views that have emerged within the health freedom movement, who is right?
As a member of the movement myself since well before Covid and author of the book The War on Informed Consent, which features a Foreword by Robert F. Kennedy, Jr., I respectfully submit that this question is sufficiently answered by a critical examination of FDA guidance proposed by Prasad and Makary in the New England Journal of Medicine.
So, let’s get to it.
Misdiagnosing the “Public Trust” Problem
To answer the question, we must first analyze the operative framework adopted by Prasad and Makary.
Echoing the view of Warp Speed’s executor, they assert that “the rapid development” of COVID‑19 vaccines in 2020 was “a major scientific, medical, and regulatory accomplishment”.
Then they lament that Americans “remain unconvinced” about the benefits of repeated booster doses.
Uptake of the vaccines “has been poor”, they write. Even health care workers “remain hesitant, with less than one third participating in the 2023–2024 fall booster program.”
The central problem, in their view, is that “public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles-mumps-rubella (MMR) vaccination”.
Prasad and Makary thus make clear that their aim is to restore “public trust” in the CDC’s vaccine recommendations.
It is from within that narrow framework that they seek to provide “guidance” to “foster evidence generation.”
The problem, though, is not that the authoritarian COVID‑19 lockdown madness and coerced mass vaccination endgame caused masses of people now distrust the “public health” establishment.
That is rather a necessary part of the solution because the real problem is that the government’s “public health” agencies have perpetually proven themselves to be completely unworthy of our trust.
By misdiagnosing the problem, Prasad and Makary arrive at the predetermined conclusion that the “evidence” generated under their proposed “guidance” will support the goal of restoring “trust” in the continuation of the government’s barbaric vaccine policies.
The Lie about ‘Herd Immunity’
To help illustrate why the goal should not be to convince Americans that they should trust the CDC et al., let’s consider just a few of the countless lies government officials told for the purpose of supporting their policy goal of achieving high vaccine uptake.
Tossed down Orwell’s memory hole by Prasad and Makary is the fact that the entire “public health” establishment brazenly lied that the shots would end the pandemic by creating “herd immunity”.
Supposed health “authorities”—from the CDC on down to healthcare providers—claimed that it was scientifically proven that two doses of an mRNA COVID‑19 vaccine would confer durable sterilizing immunity, stopping infection and transmission of SARS‑CoV‑2.
To support that assertion, they said “the science” said so—a euphemism meaning whatever anti-science preposterousness came out of the CDC or the mouths of people like Dr. Anthony “I represent science” Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) under the National Institutes of Health (NIH), another subagency of HHS.
According to Fauci, any criticism of his person ipso facto constituted “attacks on science”.
The truth, of course, was that the clinical trials were not designed to test the hypothesis that the vaccines would stop infection and transmission of the virus. Nor were the vaccines expected to confer this “sterilizing immunity” because—as Fauci later admitted—they weren’t designed to.
As CDC Director Dr. Rochelle Walensky and White House Coronavirus Response Coordinator Dr. Deborah Birx both later admitted, their claims of wondrous vaccine effectiveness were based not on science but “hope”.
When deceiving people into getting the vaccines didn’t work, the method was coercion.
When people including myself tried to warn the public about how the government and mainstream media were lying, the truth was systematically censored from social media by Big Tech companies colluding with the criminal organization in Washington to shred the First Amendment to the US Constitution.
The sin that we truthtellers were guilty of was not the spreading of “vaccine misinformation” but heresy against the vaccine religion.
The Lie about mRNA Persistence
Another lie told by the “public health” establishment was that the mRNA from the vaccines is eliminated from the body “within a few days”.
The faux “fact check” industry insisted this was true, of course, because the CDC said so.
But it wasn’t true.
It was another assumption,or belief,or hope—expressed as fact but subsequently falsified by scientific research.
The purpose of the mRNA in the vaccines is to instruct human cells to produce the spike protein of “severe acute respiratory syndrome coronavirus 2”, or SARS‑CoV‑2.
That’s the official name of the probable creation of dangerous “gain of function” research promoted and funded by Fauci’s NIAID and other government agencies.
Infection with this virus is a necessary but insufficient factor in the pathogenesis of the clinical disease called “coronavirus disease 2019”—abbreviated “COVID‑19” and colloquially referred to as just “Covid”.
To ensure delivery into human cells, the mRNA is encapsulated in a lipid nanoparticle, with the idea being to cause the immune system to generate neutralizing antibodies against the SARS‑CoV‑2 spike protein.
It is therefore concerning that the CDC’s claim of mere days of persistence in the human body turned out to be untrue.
A study published in the journal Cell in January 2022, for instance, found vaccine mRNA persisting in some people two months after vaccination.
As observed by the authors of a study published in the Journal of Pathology, Microbiology and Immunology in January 2023, the persistence of vaccine mRNA would enable “prolonged spike protein production”—and therefore, expectedly, continued immune activation and chronic inflammation.
The Lie about Spike Protein Persistence
Accompanying the lie about the vaccine mRNA was the lie that the spike protein persists for at most “a few weeks”.
It was another claim based on hope, not science.
In fact, the spike protein has been found to persist in the body for months if not years.
A study published in Proteomics Clinical Applications in August 2023 found persistence of spike protein at six months post-vaccination.
On May 13 of this year, a study in Human Vaccines & Immunotherapeutics found persistence of spike protein at over eight months post-vaccination.
A study published the previous month found persistence of spike protein in the brains of hemorrhagic stroke patients at seventeen months post-vaccination.
A preprint study in February found persistence of spike protein in individuals at nearly two years post-vaccination.
So much for at most “a few weeks”.
Concerningly, one of the theoretical explanations in the literature for this persistence is continued generation of spike protein because of genetic material from the vaccines integrating into the DNA of vaccinated individuals.
The Lie about the ‘Harmless’ Spike Protein
Accompanying the lies about how long vaccine mRNA and spike protein would last in the body was the lie that the spike is a “harmless” piece of genetic material.
The media uncritically parroted that lie from the CDC despite study after study finding the spike protein to be toxic and pathogenic.
The persistence of spike protein from vaccination is associated with “post-COVID‑19 vaccine syndrome” (PCVS)—a term used in the literature to describe vaccine injuries resembling symptoms of what’s called “Long Covid”.
The Lie about Genomic Integration
The claim was also made by the CDC—and therefore reported as fact by the media—that it was scientifically impossible for the vaccine mRNA to become integrated into human DNA.
The CDC argued that since the mRNA never enters the cell nucleus, where the DNA resides, therefore it cannot integrate into the host genome.
But that is a non sequitur fallacy. The conclusion doesn’t follow from the premise because it overlooks the possibility of mRNA being reverse transcribed into DNA that could potentially enter the cell nucleus and integrate into the host genome.
An in vitro study published in February 2023 proved in the lab that reverse transcription of vaccine mRNA into DNA is possible in human cells.
It’s a salient fact that the vaccines were literally developed using gene therapy technology.
Whenever you would hear the “fact checkers” argue that it’s a “myth” that the vaccines were a brand-new technology because there were decades of research behind them, the allusion was to years of development of mRNA technology for gene therapy applications.
The professional propagandists masquerading as journalists just left out that little detail.
The FDA-Ignored DNA Contamination
In the literature, one argument made in favor of mRNA is that it is safer for gene therapy since DNA products would pose a greater risk of permanent alteration of the host genome.
And it has been known since early 2023 that reverse transcription of mRNA into DNA isn’t even necessary for genomic integration to theoretically occur because the vaccines are contaminated with plasmid DNA from the manufacturing process.
Accompanying the DNA contamination is what’s called a “promoter” sequence from simian virus 40—the “SV40” virus that infamously contaminated polio vaccines in the 1950s and 1960s.
While it is a short segment contaminating COVID‑19 vaccines, not the whole viral sequence, the SV40 promoter is known to help transport DNA through the nuclear membrane.
And once inside the nucleus, the foreign DNA can theoretically integrate into the host genome.
In fact, it is to reduce that risk that the FDA has set regulatory safety limits on the levels of DNA allowed in injectables.
As accurately observed by intrepid reporter Dr. Maryanne Demasi—a rare honest journalist—in an article about the FDA guidance proposed by Prasad and Makary,
Multiple independent labs have shown that residual DNA in the vaccines far exceeds safety limits. Student researchers in FDA’s own lab found residual DNA levels exceeded safety limits by up to 470 times. Yet the FDA continues to ignore this evidence. [Emphasis added.]
Prasad and Makary, too, ignore this evidence in their proposal to restore “trust” in the CDC’s vaccine recommendations while continuing push the mRNA COVID‑19 vaccines on the population.
Prasad and Makary’s Cognizance of the Lies
The two individuals proposing the new guidelines in the New England Journal of Medicine are certainly not incognizant of how the COVID‑19 vaccines were sold to the public based on lies.
As Demasi also pointed out, both men signed a Citizen Petition to the FDA in January 2023 criticizing government officials for claiming that the COVID‑19 vaccine would confer “herd immunity”, even though the clinical trials were not designed to determine whether the vaccines would prevent infection and transmission of the virus.
The petition also observed the dramatic increase in reports to the Vaccine Adverse Event Reporting System (VAERS) following the COVID‑19 vaccine rollout, dwarfing all other events reported for the entire history of the program.
They don’t mention it, but that includes over 38,000 reports of death following COVID‑19 vaccination—more than the number of deaths reported for all other vaccines combined for the life of the program.
Whenever safety signals are indicated by VAERS, the mainstream media feel it obligatory to point out that a causal relationship cannot be established by this data.
It is highly instructive how the media, to reassure the public about the safety of vaccines, tout VAERS as a robust post-marketing surveillance system that would identify any existent harms of vaccination; yet when the data show alarming safety signals, suddenly VAERS becomes terribly unreliable and unfit for purpose.
This is institutionalized cognitive dissonance.
The Unproven Mortality Benefit of COVID‑19 Vaccines
Another lie told by government officials was that the clinical trials demonstrated high vaccine effectiveness against severe illness or death from COVID‑19.
That claim was made, for instance, by CDC Director Rochelle Walensky and NIAID Director Anthony Fauci.
In an article published in February 2021 in JAMA, the journal of the American Medical Association, Walensky and Fauci brazenly lied that “Clinical trials have shown that the vaccines authorized for use in the US are highly effective against COVID-19 infection, severe illness, and death.”
In fact, the outcome measured in the trials as the basis for estimating vaccine efficacy was symptomatic infection.
Measurement of this outcome was based on the existence one or more symptoms of COVID‑19—whether severe or mild—plus a positive PCR test.
The trials were not designed to determine effectiveness against the most important outcomes: severe disease, hospitalization, and death.
While severe outcomes were considered a “secondary endpoint” of the trials, they lacked adequate statistical power to assess vaccine efficacy for those outcomes.
Then once the FDA granted the vaccines “Emergency Use Authorization” (EUA) in December 2020—which is a regulatory status for products still considered experimental—the trials were effectively ended by vaccinating away the control groups.
Consequently, there remains a total absence of data from randomized controlled trials from which to determine long-term health outcomes between vaccinated and unvaccinated individuals, including the effects of these mRNA products on all-cause mortality.
This is not a trivial oversight.
Even if effective for preventing death from the target disease, vaccines can have an overall negative impact on mortality.
This is because vaccines can have what are termed in the literature “non-specific effects”, which refers to effects of vaccinations unrelated to the intended effect of preventing illness and death from the target disease.
Two top researchers in this field are Dr. Peter Aaby and Dr. Christine Stabell Benn. An example of a detrimental non-specific effect they have highlighted is the diphtheria, tetanus, and whole cell pertussis (DTP) vaccine, which—like “non-live” vaccines in general—is associated with an increased rate of childhood mortality.
Aaby and Benn were among the authors of a study published in the Lancet journal eBioMedicine in 2017 finding that children who received the DTP vaccine “had 5-fold higher mortality than still unvaccinated children.”
As the researchers appropriately remarked,
It should be of concern that the effect of routine vaccinations on all-cause mortality was not tested in randomized trials. All currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis. Though a vaccine protects children against the target disease it may simultaneously increase susceptibility to unrelated infections. [Emphasis added.]
Government policymakers, however, refuse to learn from the lessons offered by scientific inquiry.
They completely ignore the need for long-term studies to determine the effects of vaccines on overall health and all-cause mortality, just like they completely ignore the need to consider superior natural immunity as an opportunity cost of vaccination, or the need for an individualized risk-benefit analysis.
To obtain authorization, the FDA did not require the COVID‑19 vaccine manufacturers to provide evidence for a mortality benefit of their products—and hence the pharmaceutical companies did not design their studies to test the hypothesis that there would be.
In fact, the six-month follow up data from Pfizer’s trial, published in the New England Journal of Medicine, showed fourteen deaths in the placebo group, only two of which were attributed to COVID‑19, and fifteen deaths among vaccinated subjects, resulting in an equivalent rate of death in both groups.
A notable disparity was one death from heart attack in the placebo group versus four among the vaccinated.
Aaby and Benn were also coauthors of a Lancet preprint study published in April 2022 that reanalyzed clinical trial data for both Pfizer’s and Moderna’s products and found no mortality benefit from the mRNA COVID‑19 vaccines.
As another illustration of the institutionalized cognitive dissonance, observational studies are routinely touted by the CDC and media as absolute proof of an absence of harm from vaccines—yet whenever such a study does find an association between vaccination and some harm, we are reminded that this type of study design cannot prove causality.
As Dr. Aaby stated during a talk he gave in March 2019, “it’s important to recognize that no routine vaccine was tested for all the effect on mortality in randomized trials before being introduced.”
“I guess most of you think that we know what all our vaccines are doing,” he added. “We don’t.”
‘Safe and Effective’ or Highly Dangerous?
Setting aside the unproven claims of a beneficial effect on mortality, the FDA’s rubber stamping of COVID‑19 vaccines allows them to be marketed as “safe”.
We’ve already seen how that assertion is challenged by VAERS data. The many harms from the shots are also abundantly documented in the literature by observational studies, but even the data from the randomized controlled trials used by the FDA as supporting evidence call the description of “safe” into question.
A reanalysis of trial data published in the journal Vaccine in September 2022 found that the mRNA COVID‑19 vaccines “were associated with an excess risk of serious adverse events of special interest [AESI] of 12.5 per 10,000 vaccinated”—a 43% greater risk of an AESI in the vaccinated relative to the placebo control group.
In both Pfizer and Moderna trials, the excess risk of such serious adverse events “was higher than the risk reduction for COVID‑19 hospitalization relative to the placebo group”.
In other words, getting vaccinated was more likely to result in hospitalization for a serious adverse event of special interest than to prevent hospitalization for COVID‑19.
The ‘Badly Designed’ COVID‑19 Vaccine Clinical Trials
Problems with the COVID‑19 vaccine trials were also highlighted in a paper published this past January in the Journal of the Academy of Public Health.
The notable authors were Dr. Jay Bhattacharya and Dr. Martin Kulldorff, who also co-authored the Great Barrington Declaration of October 2020, which criticized the lockdowns and advocated the more sensible approach of “focused protection”.
Dr. Bhattacharya was nominated by Donald Trump to direct the National Institutes of Health (NIH) and has served in that role since April.
As Bhattacharya and Kulldorff noted in their paper, the original trials were “badly designed”.
The “fundamental design flaws” included the failure to measure the most important clinical endpoints: severe disease, hospitalization, and death.
They also acknowledged how government officials who routinely made claims about vaccine effectiveness that were unsupported by the scientific evidence—which they generously attributed to “a failure in the interpretation of the trials”.
As Bhattacharya and Kulldorff also observed,
When the bivalent booster was developed in 2022, pharmaceutical companies did not conduct proper randomized control trials. Instead, Pfizer and Moderna ran trials that had the immunogenicity of the bivalent boosters as the primary clinical endpoint. [Emphasis added.]
In other words, the FDA “looked only at whether the vaccine could produce antibodies in the patient population.”
Data from human subjects wasn’t even required. Pfizer’s trial “looked only at immunogenicity in mice.”
It was on that basis that the FDA rubber-stamped the shots.
In conclusion, Bhattacharya and Kulldorff called on the FDA to “require pharmaceutical companies to conduct trials with clinically and epidemiologically meaningful endpoints”—instead of trials that are “not useful.”
So, there you have it, straight from the current NIH director: the clinical trials used by the FDA rubber stamp the mRNA COVID‑19 were useless.
The Regulatory Malfeasance and Scientific Fraud of FDA Authorizations
When it comes to the continued practice of mass vaccinating children and pregnant women, it gets even worse.
To this day, the COVID‑19 vaccines remain FDA unapproved for children aged six months through eleven years.
Instead, the shots continue to be administered for this age group under “emergency use” authorization—notwithstanding the complete absence of any kind of emergency that could possibly justify such a mass uncontrolled experiment on the US childhood population.
To describe this as criminal recklessness is an understatement.
The FDA’s authorizations for young children were also not based on clinical trial data demonstrating safety and efficacy.
Instead, the FDA relied on “immunobridging” data. The FDA assumed vaccine effectiveness based on an arbitrarily defined level of antibodies in the blood.
In other words, the FDA relied on measurement of antibody levels generated by vaccination as a surrogate measure of immunity—even though no correlates of immunity have been scientifically validated for SARS‑CoV‑2.
In essence, to push through authorization of the vaccines for children, the FDA relied on scientific fraud.
Vinay Prasad and Marty Makary are perfectly aware of how unscientific the FDA’s authorizations were.
In their citizens petition to the FDA, they also criticized the agency for not requiring COVID‑19 vaccine manufacturers Pfizer and Moderna to disclose in their package inserts that the measurement of antibody levels as a “surrogate endpoint” for vaccine effectiveness “has not been validated”.
Additionally, they cited an FDA advisory committee meeting in which a Pfizer representative acknowledged that they were “unable to really come up with an antibody threshold” because immunity is “a much more complex story and not just easily addressed with neutralizing antibodies.”
The FDA itself admitted at the meeting that measurement of antibodies has not been established as an “immune correlate of protection”, so in lieu of clinical trials demonstrating efficacy, the FDA was “using poor man’s immune correlates of protection”.
Additionally, pregnant women were excluded from the COVID‑19 vaccine clinical trials on the grounds that it would be unethical to subject expectant mothers to experimentation.
Yet the CDC recommends the shots for pregnant women, anyway, thus effectively moving the experiment out of a controlled clinical setting and instead treating the general population of pregnant women as subjects of a mass uncontrolled experiment in which properly informed consent is a logical impossibility.
So, ask yourself: Who is HHS really serving?
Is this really in the best interests of public health—or primarily to serve the financial interests of the pharmaceutical industry?
The answer to that question ought to be glaringly obvious to any sane person capable of rational and independent thought.
The Scientific Fraud of PCR Testing
We’ve already seen how the original trials asked the wrong question: whether the vaccines reduced the risk of symptomatic infection, instead of whether they reduced the risk of severe disease and death.
Aside from that problem, the resulting estimates of vaccine effectiveness may have been exaggerated due to the tool used to measure the primary endpoint: a positive PCR test.
The PCR tests for COVID‑19 are designed to detect tiny fragments of viral RNA, not to confirm the presence of whole viable virus.
Consequently, a positive result does not necessarily mean that the patient has an active infection.
The tests work by reverse-transcribing viral RNA into DNA and then cyclically amplifying the DNA until it meets a certain threshold for positivity.
This is called the “cycle threshold”, or “Ct” value.
During the lockdown madness, cycle thresholds for test positivity were set so high that, as the New York Times admitted in August 2020, “up to 90 percent of people testing positive carried barely any virus” and were “not likely to be contagious.”
Dr. Anthony Fauci himself admitted in July 2020 that PCR tests were being run at such high cycle thresholds that “the chances of it being replication competent are miniscule”, and the amplified RNA most likely represented “just dead nucleotides, period.”
This didn’t stop the “public health” establishment from counting anyone testing positive as a “COVID‑19 case”—regardless of symptoms.
In other words, to support “lockdown” policies and their coerced mass vaccination endgame, PCR tests were used to perpetrate systematic scientific fraud in the counting of “COVID‑19” cases.
The clinical trials for COVID‑19 vaccines upped the standard a bit: instead of just a positive PCR test, the FDA also required the presence of one or more symptoms of COVID‑19. Any mild symptom would do.
Exclusion of other potential causes for the reported symptoms was not required.
While that minimal standard may have reduced the likelihood of false positive PCR results, it did not solve the inherent problem of a false discovery rate.
The false positive rate is related to test specificity and indicates the proportion of tested individuals who receive a positive PCR test despite not having a viral infection.
The false discovery rate is related to disease prevalence and indicates the probability that someone who receives a positive PCR test result does not actually have a viral infection.
The distinction is in the denominator: for the false positive rate, it’s everyone tested who does not have a viral infection, whereas for the false discovery rate, it’s everyone in the population who tests positive.
Imagine that the PCR test is 99% specific, meaning that, among everyone in a population who is tested, one out of every hundred people who are uninfected will receive a positive result. The false positive rate is 1%.
Now suppose that only one out every hundred people in the population have an infection, or a disease prevalence of 1%.
For every 1,000 people tested, only ten will have an infection. That leaves 990 people who are not infected—but among whom about 1% will still receive a positive PCR test result.
The result is twenty positive results, including ten false positives. That’s a false discovery rate of 50%.
Thus, when testing large numbers of people in a low-prevalence setting, even a highly specific PCR test can produce a high proportion of incorrect “positive” results.
In an October 2022 study in the journal Science, Public Health Policy & the Law, Dr. Sin Hang Lee, a pathologist and director of the Milford Molecular Diagnostics Laboratory in Connecticut, explained how the cycle threshold values for PCR tests were “an unproven surrogate” for detection of whole viable virus.
Technically, these are “reverse transcription quantitative polymerase chain reaction” assays, or RT-qPCR tests, typically referred to by the media as just “PCR” tests.
Dr. Lee used Sanger sequencing, a gold-standard method for verifying the nucleotide sequence of PCR-amplified DNA fragments, to reexamine test-positive patient samples acquired that January.
He found that SARS‑CoV‑2 was detected by both PCR and Sanger sequencing in only twenty-nine of fifty samples—a false discovery rate of 42%.
As Dr. Lee remarked,
Using RT‑qPCR tests with false-positive results to evaluate the endpoint in COVID‑19 vaccine development might have artificially inflated the vaccine effectiveness. . . . Without confirmatory Sanger sequencing of the RT‑qPCR products, the claim of the BNT162b2 [Pfizer-BioNTech COVID‑19 vaccine] being 95% effective against COVID‑19 becomes questionable. [Emphasis added.]
Dr. James Lyons-Weiler, Editor-in-Chief of the publishing journal, Science, Public Health Policy & the Law, further elucidated the implications. Assuming a 5 percent disease prevalence rate in the population, the 42% false discovery rate would mean that for every fifty true positives, there will be thirty-six false positive results. The number of “COVID‑19 cases” reported based on PCR testing would be overstated by a factor of 72%.
As Dr. Lyons-Weiler concluded, “There are no credible COVID‑19 vaccine trial data.”
That’s in addition to all the fatal flaws that prompted the current NIH director to characterize the clinical trials as worthless.
The argument could easily be made that the trials were much less than worthless.
Critical Analysis of the Proposed FDA Guidance
There’s also much more that could be said about the problems with COVID‑19 vaccines, like the immunological phenomenon of “original antigenic sin”, the problem of antibody class switching from neutralizing antibodies to IgG4 and potential “immune tolerance” to the spike protein, or the institutionalized failure to consider superior natural immunity as an opportunity cost of vaccination; but all of the above information is sufficient context for putting the newly proposed FDA guidance into proper perspective.
Recall the key question: Was this journal article by FDA officials a big victory for health freedom, or a public relations ploy aimed at disarming the health freedom movement?
So now, to try to find a reasonable answer to that critical inquiry, let us continue our examination of the guidance proposed by Prasad and Makary under the leadership of HHS Secretary Kennedy, who is in turn acting under the ostensible “leadership” of President Trump.
An Opinion Piece, Not FDA Policy
To start with, the article by Prasad and Makary in the New England Journal of Medicine does not represent any kind of official FDA guidance to the industry.
It is instead essentially an opinion piece reflecting the authors’ views and stated intentions, which is quite different from a change in government policy.
There is no legal or regulatory force behind their proposed guidance, and the ideas proposed would still need to be formally adopted within the FDA regulatory apparatus.
It’s a proposed change, not an achieved one—and this is not a trivial distinction.
Regulatory Sleight-of-Hand
According to Secretary Kennedy, the proposed new guidance shows that the FDA “is finally breaking away from the one-size-fits-all vaccine policy that authorized the COVID shots for every American over 6 months old.”
However, that conclusion is unsupported by Prasad and Makary’s description of the proposed FDA guidance for vaccine manufacturers.
Consider the following points:
- Under the current regulatory structure, the FDA authorizes or approves formulations of COVID‑19 vaccines—not their specific use as a primary series versus booster doses.
- The original vaccine trials were conducted for—and the initial authorizations were based on—formulations that are no longer in use and that aimed to generate neutralizing antibodies to the original Wuhan strain of SARS‑CoV‑2, which has long since been extinct outside of laboratories.
- Because this coronavirus is constantly evolving, the manufacturers are instructed by the FDA produce “updated” formulations.
- Each new formulation is designed to induce a sufficient level of neutralizing antibodies against the mutated spike protein to meet the regulatory “immunobridging” requirement.
- The FDA does not require the manufacturers to provide clinical trial data supporting the safety and effectiveness of new formulations.
It is important to recognize that by limiting their proposed new FDA guidance strictly to booster doses, Prasad and Makary are indicating that, when it comes to the primary series of COVID‑19 vaccinations, absolutely nothing will change.
The FDA will not require supporting data from randomized controlled trials to support any new authorizations or approvals of “updated” COVID‑19 vaccines intended for use in previously unvaccinated individuals, including children and pregnant women.
On that basis alone, the proposed guidance must be seen as a cynical public relations stunt, not a sincere and honest effort to establish an evidence-based approach to vaccine regulation.
Making Randomized Controlled Trials Voluntary
After establishing the goal of restoring “trust” in the CDC’s vaccine recommendations and limiting their questioning of those recommendations to only annual COVID‑19 booster shots, Prasad and Makary begin to outline their proposed new FDA guidance as follows:
Moving forward, the FDA will adopt the following Covid‑19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titres in people—the FDA anticipates that it will be able to make favorable benefit-risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid‑19 outcomes, as described by the CDC. For all healthy persons—those with no risk factors for severe Covid‑19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a Covid‑19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of the post-marketing commitment. [Emphasis added.]
Let’s break that down and read between the lines.
First, they clearly indicate that, to ensure future authorizations of COVID‑19 booster doses for the elderly or anyone else with a “risk factor”, the FDA will continue relying on its “immunobridging” fraud—not placebo-controlled trials.
That is, the FDA would predetermine that “booster” doses of new COVID‑19 vaccines are “safe and effective”, provided the shots induce an arbitrarily determined level of antibodies.
Only if the manufacturers also wish their target market to include non-elderly people deemed “healthy” would the FDA require new randomized controlled trials.
In other words, whether new trials are conducted is entirely up to the vaccine manufacturers.
It doesn’t take a genius to anticipate the outcome of that disincentivizing framework.
The Broad Exclusionary Criteria for Voluntary Trials
As if it weren’t bad enough already that the proposed FDA guidance would essentially make new clinical trials voluntary, Prasad and Makary go further in their instructions to COVID‑19 vaccine manufacturers for how to ensure EUA status or licensure.
In their journal article, they provide a table listing “underlying conditions” that the CDC has defined as “risk factors” for severe COVID‑19.
The list includes asthma; heart disease; diabetes; obesity; kidney, liver, or lung disease; immunodeficiency; cancer; use of corticosteroids or other immunosuppressive drugs; and current or former smoking.
Here is the full list presented in the NEJM article:
By their own reckoning, Prasad and Makary anticipate that these criteria will facilitate the continued use of COVID‑19 booster shots for between 30% and 60% of the US population without requiring evidence from randomized controlled trials to support the policy.
Note that the list also includes pregnancy.
So, these top FDA officials—now branded as “MAHA” leaders—are instructing COVID‑19 vaccine manufacturers, if they would like to conduct voluntary trials, to exclude pregnant women.
The FDA’s Preferred Study Design
Continuing in their article, Prasad and Makary further detail “the FDA’s preferred study design” for any voluntary trials.
To start with, they describe the “ideal population” for such trials as “the 50–64 year-old age group”.
In other words: Go ahead and exclude anyone under age fifty.
Prasad and Makary also tell Big Pharma what endpoint they should measure:
The FDA’s preferred primary end point in these trials will be symptomatic Covid‑19, with special attention paid to several secondary end points: severe Covid‑19, hospitalization, and death.
In other words: Go ahead and repeat the same poor design of your original trials that rendered them useless in the first place.
Under the proposed FDA guidance, the primary endpoint any new clinical trials would remain the same as the original trials: one or more symptoms of COVID‑19 plus a positive PCR test.
Like the original trials, meaningful clinical outcomes will be mere “secondary end points” to which the manufacturers should pay some attention, but for which they won’t be required to generate statistically significant data.
For the original trials, the FDA required an average estimated effectiveness against symptomatic infection of 50%. Prasad and Makary don’t specify what it would be for new trials. They only state that
Sample-size calculations should aim to demonstrate that vaccines reduce the incidence of the primary end point with a lower confidence interval bound that is ideally above 30%.
They don’t say what the upper confidence interval bound should be.
Why cite a lower bound without an upper bound? And instead of providing expected boundaries for confidence intervals, why wouldn’t they just state what average vaccine effectiveness would be acquired to gain FDA authorization or approval? Unless the aim was to leave enough wriggle room to authorize the shots even if falling short of 50% effectiveness against the practically meaningless endpoint of symptomatic infection?
In one regard, at least, the FDA officials appear to suggest a modest improvement over the original trials, which generally excluded people with a prior history of SARS‑CoV‑2 infection.
Of course, that didn’t stop the CDC from recommending the shots for people who’d already acquired natural immunity—which Prasad and Makary concede is “robust.”
Ostensibly to correct that oversight, Prasad and Makary suggest, “People who have had Covid‑19 in the past year should not be excluded—since evidence is needed for the average American.” (Emphasis added.)
That makes it sound as though the aim of their guidance is to produce data representative of the general US population. But that can’t be true since the average American isn’t healthy.
Ergo, there is again an encrypted underlying instruction here for the vaccine manufacturers wishing to target “healthy” Americans with their products: Go ahead and exclude from your trials anyone whose natural immunity to SARS‑CoV‑2 prevented them from getting COVID‑19 within the past year.
Continuing, the FDA officials state that to “provide reassurance” to Americans that the “repeat-boosters-in-perpetuity strategy is evidence-based”, the duration of follow-up would need to be at least six months.
That’s enough time to enable the FDA to say it hasn’t lowered the standards from the original trials while enabling the vaccine manufacturers to hopefully avoid a finding of negative vaccine effectiveness, as observational studies have found when looking beyond six months since vaccination—including for children.
Furthermore, the use of a saline placebo would not be required.
Instead, Prasad and Makary explain that “The control group could receive a saline placebo, to permit documentation of the full adverse-event profile.” (Emphasis added.)
One must assume that the choice of the verb “could” instead of “must” was not unintentional.
“Balancing” Pharma Profits with Public Health
After providing those instructions to the vaccine manufacturers for how they can essentially rig any voluntarily conducted trials, Prasad and Makary preposterously assert that their proposed guidance “balances competing values.”
Just what “values” are they trying to “balance”?
“First,” they explain, “our acceptance of immunologic end points ensures that we can provide timely approval to a broad population.”
Translation: We need to serve Big Pharma’s financial interests by continuing the mass uncontrolled experiment of injecting millions of people with annual COVID‑19 shots, and so, to achieve that predetermined goal, we are going to continue perpetrating scientific fraud.
As they point out, “The range of diseases in the CDC definition of high risk of severe disease is vast, including obesity and even mental health conditions such as depression.”
Not to mention pregnancy.
“Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”
Hooray. Mission accomplished.
The first “value” they wish to “balance” against other “competing” interests is thus to ensure profits for Big Pharma.
“Second,” they write, “our policy also balances the need for evidence.”
Translation: We must lower on our standards of evidence to be able to continue the policy of mass COVID‑19 vaccination.
They assert, “This policy will compel much-needed evidence generation.”
Except that it won’t. Any randomized controlled trials the manufacturers might conduct will be strictly voluntary, and even if they are conducted, they will just be more sham studies.
Demand for the shots is already low. As of April, according to the CDC, only 20.4% of adults have received the 2024 – 2025 formulations of COVID‑19 vaccines, with highest coverage among the elderly, among whom uptake is still just 39.1%.
Consequently, we can anticipate that Big Pharma will be willing to deprioritize healthy people under age 65 as a target population for their products to avoid having to produce evidence that the vaccines are safe and effective.
And even if not, whether a saline placebo is used for the control group will likewise be up to the manufacturers.
“Third,” Prasad and Makary continue, “our proposed postmarketing study does not preclude the conduct of additional randomized studies, particularly studies in pediatric populations.”
Translation: We’re not going to require you to conduct trials to provide evidence for our continued authorization of your products for children.
In concluding, they assert that “The FDA’s new Covid‑19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.”
But that is an inherent self-contradiction.
If they were committed to gold-standard science, they wouldn’t try to “balance” the need for evidence with their policy goal of continuing to inject millions of people with COVID‑19 shots annually.
The “regulatory flexibility” they refer to requires them to adopt such standards of evidence that the word “abysmal” hardly even applies; a more proper description is outright scientific fraud.
Their assertion that this represents “gold-standard science” is preposterous, an outrageous ongoing effort to gaslight the public—and now with the approval of the “MAHA” leadership.
The proposed FDA guidance would essentially continue to place the burden on the public to prove that a pharmaceutical product is dangerous and ineffective before it is pulled from the market—as opposed to requiring COVID‑19 vaccine manufacturers to prove that their gene therapy products are “safe and effective”.
Conclusion
This is a defining moment for the health freedom movement, and all the warrior moms and dads who’ve long been active in the grassroots health freedom movement are now being asked by people in the political “MAHA” movement to accept extraordinary compromises.
That is not an easy ask for many of these warriors—including all the “ex-vaxxers” who did follow the CDC’s recommendations only to see their children injured or killed by vaccines.
These victims of medical tyranny should not be told to be silent and withhold criticism on the grounds that we must support Bobby Kennedy and “trust” the plan.
People long involved in the fight against medical authoritarianism—whether parents or not—should not be ridiculed and dismissed with the strawman fallacy that they are expecting miracles from Secretary Kennedy when the miracle of government reform is precisely what Mr. Kennedy promised them if they voted for Donald Trump.
It comes down to the question of correct diagnosis.
Secretary Kennedy and many of his MAHA supporters diagnose the problem as “corporate capture” of government agencies like the FDA and CDC, and they fervently believe that if only the right person can be put into position within the halls of power that America will be made healthy again.
But the fundamental problem isn’t that corporations use government power to circumvent the free market to advance their financial agendas. The problem is that government agencies like the FDA and CDC exist to be captured in the first place.
It simply isn’t the case that the CDC et al. are “broken” and need to be “fixed”. There are no reforms that could possibly fix them because they are functioning exactly according to design.
Epilogue
Since I first conducted and started writing this analysis of the journal article by Prasad and Makary, on May 27, Secretary Kennedy posted a message to X stating that the recommendation “for healthy children and healthy pregnant women” had been removed from the CDC’s vaccine schedule.
His post contained a video of him making the announcement while standing alongside NIH Director Bhattacharya and FDA Commissioner Makary.
Accessing the CDC’s routine childhood vaccine schedule on the CDC’s website at the time showed that the last time this page had been updated was November 21, 2024. The page has now been updated as of May 29. The COVID‑19 vaccine, of course, remains on the schedule, with a link directing users to an updated “Notes” page.
The recommendation remains for COVID‑19 vaccination of children “Ages 6 month – 17 years who are NOT moderately or severely immunocompromised.”
The relevant change is that the CDC now states,
Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.
A link is provided to another page further explaining that a “shared clinical decision-making recommendation” is “when individuals may benefit from vaccination, but broad vaccination of people in that group is unlikely to have population-level impacts.”
Of course, all vaccinations should be based on an informed decision process between the health care provider and the patient or parent, and the fact that the CDC rejects this for other vaccinations just illustrates how perverse the system is.
There is nothing about the recommendation for COVID‑19 vaccination to occur as part of this “shared clinical decision-making” excluding healthy children.
As I’m writing this, the CDC’s page “COVID‑19 Vaccination for Women Who are Pregnant or Breastfeeding” still recommends the shots for pregnant women, declaring this “safe and effective” despite the absence of clinical trial data to support that claim.
The page indicates it was last updated on September 10, 2024, but a banner under the page title says, “COVID-19 vaccine recommendations have recently been updated for some populations. This page will be updated to align with the updated immunization schedule.”
Clicking the link to “learn more” lands one on the CDC’s vaccine schedule page, updated on May 29. Clicking from there to view the adult schedule, the COVID‑19 vaccine is listed as a “Recommended vaccination for adults who meet age requirement, lack documentation of vaccination, or lack evidence of immunity”.
Clicking to view the “Notes” page, it states that COVID‑19 vaccination is recommended for adults “Age 19–64 years”.
There is nothing on either page about healthy pregnant women being excluded from the CDC’s recommendation.
The only relevant change is to a second table listing recommendations by medical condition instead of by age. Previously, this table explicitly recommended COVID‑19 vaccination for pregnant women, whereas now “Pregnancy” is shown as a category for which the CDC offers “No Guidance”.
The CDC’s “Notes” page explains that healthcare providers should first look at the table listing recommendations by age, then by medical condition, then to consult the CDC’s dosing information on the same page, and finally to review the CDC’s contraindications and precautions.
Pregnancy is not listed as a contraindication to COVID‑19 vaccines or as a condition warranting any precautions.
It appears that Kennedy’s claim that the CDC had removed its recommendation that healthy children and healthy pregnant women receive the shots was incorrect.
As Axios accurately observed, the CDC continues to recommend the shots for all children aged six months or older after consultation with a medical provider, thus “contradicting HHS Secretary Robert F. Kennedy’s push to drop the shots for healthy kids.”
The American Academy of Pediatrics (AAP), which colludes with the CDC to make its recommendations “standard of care” in pediatric practices across the country, “expressed relief” about the updated recommendations not matching Kennedy’s statement.
Similarly, the updated recommendations do not exclude pregnant women, healthy or otherwise. Instead, the CDC opted to provide no specific guidance for vaccination during pregnancy while generally recommending the shots for all adults, especially those considered at higher risk from COVID‑19, while also telling providers that this list includes pregnant women.
That is hardly the same thing as the CDC excluding healthy pregnant women from its recommendations.
Since I finished writing my above analysis of the proposed FDA guidance, the FDA has approved Moderna’s new mRNA COVID‑19 vaccine, “mNEXSPIKE”. According to Moderna’s May 31 press release, it’s been approved “for use in all adults 65 and older, as well as individuals aged 12–64 years with at least one or more underlying risk factor [sic] as defined by the Centers for Disease Control and Prevention (CDC).”
Actually, though, the FDA approved mNEXSPIKE “for use in individuals” meeting those criteria and who also “have been previously vaccinated with any COVID‑19 vaccine”. In other words, it has been approved specifically for use as a booster shot.
A footnote for that misleading statement in the press release links to the CDC’s page “Underlying Conditions and the Higher Risk for Severe COVID-19”, where it shows a list of these “risk factors”—including “Pregnancy and recent pregnancy”.
The press release explains how the FDA’s approval of the new vaccine was based on a clinical trial of “11,400 participants aged 12 years and older” designed “to demonstrate the non-inferior vaccine efficacy” compared to Moderna’s originally approved mRNA COVID‑19 vaccine, “Spikevax”.
The new vaccine “was found to have a similar safety profile” to the old one—which is hardly reassuring.
The new Moderna product was described as “a step toward next-generation coronavirus vaccines” by CBS News, which noted that it’s “a second option” and “not a replacement for the company’s existing shot”, which “doesn’t face those limits” of being approved only for individuals with “risk factors”.
Pregnant women were, of course, excluded from the clinical trial for Moderna’s new vaccine. It was a vaccinated versus vaccinated study, with no placebo control group.
For one arm of the study, only individuals previously vaccinated with a primary series were included, and for those over age 18, prior receipt of at least one booster does was required. A second arm did not require prior vaccination.
Moderna measured individuals’ “seroresponse” to the vaccine, or the change in antibody levels, and only estimated vaccine effectiveness relative to its original formulation.
The trial’s page on the database site ClinicalTrials.gov indicates that the trial data has not been published.
As with the original vaccines recommended by the CDC for pregnant women, the package insert for “mNEXSPIKE”—available on the FDA’s website—discloses that available data “are insufficient to inform vaccine-associated risks in pregnancy.”
Like the original vaccines, the new product “has not been evaluated for potential to cause carcinogenicity, genotoxicity, or impairment of male fertility in animals.”
The reference in that statement to “male” fertility only is because a study was done in female rats. Moderna claims no “vaccine-related” adverse effects were observed, which raises the question of what effects were observed that Moderna presumed were unrelated. Notably, the description of this animal study does not indicate that an unvaccinated group of female rates was used for comparison.
The data disclosed in the insert reveals that the estimated relative vaccine efficacy of 9.3% was not statistically significant. That is, the new shot was not shown to offer significantly greater protection against symptomatic infection with circulating SARS‑CoV‑2 variants than the original vaccine targeting the spike protein of the original Wuhan strain. Effectively, the FDA approved the shot based only on antibody data and the scientific fraud of assuming that an arbitrarily determined increase equates to immunity.
This is what the FDA vaccine approval process looks like for the “next generation” of mRNA products under the now “MAHA”-approved regime.
The critical distinction between the uncompromising grassroots movement and the political charade in Washington should not be lost on health freedom advocates.
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About Jeremy R. Hammond
I am an independent journalist dedicated to exposing state propaganda designed to manufacture consent for criminal government policies. I provide deeply researched analyses on critical issues including US foreign policy, the economy, and health freedom.
I am a Research Fellow at The Libertarian Institute and author. My books include Obstacle to Peace: The US Role in the Israeli-Palestinian Conflict and The War on Informed Consent.
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