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FDA Lab Uncovers Excess DNA Contamination in Covid-19 Vaccines

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An explosive new study conducted within the US Food and Drug Administration’s (FDA) own laboratory has revealed excessively high levels of DNA contamination in Pfizer’s mRNA Covid-19 vaccine.

Tests conducted at the FDA’s White Oak Campus in Maryland found that residual DNA levels exceeded regulatory safety limits by 6 to 470 times.

The study was undertaken by student researchers under the supervision of FDA scientists. The vaccine vials were sourced from BEI Resources, a trusted supplier affiliated with the National Institute of Allergy and Infectious Diseases (NIAID), previously headed by Anthony Fauci.

Recently published in the Journal of High School Science, the peer-reviewed study challenges years of dismissals by regulatory authorities, who had previously labelled concerns about excessive DNA contamination as baseless.

The FDA is expected to comment on the findings this week. However, the agency has yet to issue a public alert, recall the affected batches, or explain how vials exceeding safety standards were allowed to reach the market.

The Methods

The student researchers employed two primary analytical methods:

  • NanoDrop Analysis – This technique uses UV spectrometry to measure the combined levels of DNA and RNA in the vaccine. While it provides an initial assessment, it tends to overestimate DNA concentrations due to interference from RNA, even when RNA-removal kits are utilised.
  • Qubit Analysis – For more precise measurements, the researchers relied on the Qubit system, which quantifies double-stranded DNA using fluorometric dye.

Both methods confirmed the presence of DNA contamination far above permissible thresholds. These findings align with earlier reports from independent laboratories in the United StatesCanada, AustraliaGermany, and France.

Expert Reaction

Kevin McKernan, a former director of the Human Genome Project, described the findings as a “bombshell,” criticizing the FDA for its lack of transparency.

“These findings are significant not just for what they reveal but for what they suggest has been concealed from public scrutiny. Why has the FDA kept these data under wraps?” McKernan questioned.

CSO and Founder of Medicinal Genomics

While commending the students’ work, he also noted limitations in the study’s methods, which may have underestimated contamination levels.

“The Qubit analysis can under-detect DNA by up to 70% when enzymes are used during sample preparation,” McKernan explained. “Additionally, the Plasmid Prep kit used in the study does not efficiently capture small DNA fragments, further contributing to underestimation.”

In addition to genome integration, McKernan highlighted another potential cancer-causing mechanism of DNA contamination in the vaccines.

He explained that plasmid DNA fragments entering the cell’s cytoplasm with the help of lipid nanoparticles could overstimulate the cGAS-STING pathway, a crucial component of the innate immune response.

“Chronic activation of the cGAS-STING pathway could paradoxically fuel cancer growth,” McKernan warned. “Repeated exposure to foreign DNA through COVID-19 boosters may amplify this risk over time, creating conditions conducive to cancer development.”

Adding to the controversy, traces of the SV40 promoter were detected among the DNA fragments. While the authors concluded that these fragments were “non-replication-competent” meaning they cannot replicate in humans, McKernan disagreed.

“To assert that the DNA fragments are non-functional, they would need to transfect mammalian cells and perform sequencing, which wasn’t done here,” McKernan stated.

“Moreover, the methods used in this study don’t effectively capture the full length of DNA fragments. A more rigorous sequencing analysis could reveal SV40 fragments several thousand base pairs long, which would likely be functional,” he added.

Regulatory Oversight under Scrutiny

Nikolai Petrovsky, a Professor of Immunology and director of Vaxine Pty Ltd, described the findings as a “smoking gun.”

“It clearly shows the FDA was aware of these data. Given that these studies were conducted in their own labs under the supervision of their own scientists, it would be hard to argue they were unaware,” he said.

Nikolai Petrovsky, Professor of Immunology and Infectious Disease at the Australian Respiratory and Sleep Medicine Institute in Adelaide

Prof Petrovsky praised the quality of work carried out by the students at the FDA labs.

“The irony is striking,” he remarked. “These students performed essential work that the regulators failed to do. It’s not overly complicated—we shouldn’t have had to rely on students to conduct tests that were the regulators’ responsibility in the first place.”

The Australian Therapeutic Goods Administration (TGA), which has consistently defended the safety of the mRNA vaccines, released its own batch testing results, claiming they met regulatory standards. However, Prof Petrovsky criticised the TGA’s testing methods.

“The TGA’s method was not fit for purpose,” he argued. “It didn’t assess all the DNA in the vials. It only looked for a small fragment, which would severely underestimate the total amount of DNA detected.”

Implications for Manufacturers and Regulators

Now that DNA contamination of the mRNA vaccines has been verified in the laboratory of an official agency and published in a peer-reviewed journal, it becomes difficult to ignore.

It also places vaccine manufacturers and regulators in a precarious position.

Addressing the contamination issue would likely require revising manufacturing processes to remove residual DNA, which Prof Petrovsky explained would be impractical.

“The only practical solution is for regulators to require manufacturers to demonstrate that the plasmid DNA levels in the vaccines are safe,” Prof Petrovsky stated.

“Otherwise, efforts to remove the residual DNA would result in an entirely new vaccine, requiring new trials and effectively restarting the process with an untested product.”

Now the onus is on regulators to provide clarity and take decisive action to restore confidence in their oversight. Anything less risks deepening the scepticism of the public.

Both the US and Australian drug regulators have been approached for comment.

Republished from the author’s Substack

Author

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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Brownstone Institute

The Unmasking of Vaccine Science

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From the Brownstone Institute

By Maryanne DemasiMaryanne Demasi  

I recently purchased Aaron Siri’s new book Vaccines, Amen.  As I flipped though the pages, I noticed a section devoted to his now-famous deposition of Dr Stanley Plotkin, the “godfather” of vaccines.

I’d seen viral clips circulating on social media, but I had never taken the time to read the full transcript — until now.

Siri’s interrogation was methodical and unflinching…a masterclass in extracting uncomfortable truths.

In January 2018, Dr Stanley Plotkin, a towering figure in immunology and co-developer of the rubella vaccine, was deposed under oath in Pennsylvania by attorney Aaron Siri.

The case stemmed from a custody dispute in Michigan, where divorced parents disagreed over whether their daughter should be vaccinated. Plotkin had agreed to testify in support of vaccination on behalf of the father.

What followed over the next nine hours, captured in a 400-page transcript, was extraordinary.

Plotkin’s testimony revealed ethical blind spots, scientific hubris, and a troubling indifference to vaccine safety data.

He mocked religious objectors, defended experiments on mentally disabled children, and dismissed glaring weaknesses in vaccine surveillance systems.

A System Built on Conflicts

From the outset, Plotkin admitted to a web of industry entanglements.

He confirmed receiving payments from Merck, Sanofi, GSK, Pfizer, and several biotech firms. These were not occasional consultancies but long-standing financial relationships with the very manufacturers of the vaccines he promoted.

Plotkin appeared taken aback when Siri questioned his financial windfall from royalties on products like RotaTeq, and expressed surprise at the “tone” of the deposition.

Siri pressed on: “You didn’t anticipate that your financial dealings with those companies would be relevant?”

Plotkin replied: “I guess, no, I did not perceive that that was relevant to my opinion as to whether a child should receive vaccines.”

The man entrusted with shaping national vaccine policy had a direct financial stake in its expansion, yet he brushed it aside as irrelevant.

Contempt for Religious Dissent

Siri questioned Plotkin on his past statements, including one in which he described vaccine critics as “religious zealots who believe that the will of God includes death and disease.”

Siri asked whether he stood by that statement. Plotkin replied emphatically, “I absolutely do.”

Plotkin was not interested in ethical pluralism or accommodating divergent moral frameworks. For him, public health was a war, and religious objectors were the enemy.

He also admitted to using human foetal cells in vaccine production — specifically WI-38, a cell line derived from an aborted foetus at three months’ gestation.

Siri asked if Plotkin had authored papers involving dozens of abortions for tissue collection. Plotkin shrugged: “I don’t remember the exact number…but quite a few.”

Plotkin regarded this as a scientific necessity, though for many people — including Catholics and Orthodox Jews — it remains a profound moral concern.

Rather than acknowledging such sensitivities, Plotkin dismissed them outright, rejecting the idea that faith-based values should influence public health policy.

That kind of absolutism, where scientific aims override moral boundaries, has since drawn criticism from ethicists and public health leaders alike.

As NIH director Jay Bhattacharya later observed during his 2025 Senate confirmation hearing, such absolutism erodes trust.

“In public health, we need to make sure the products of science are ethically acceptable to everybody,” he said. “Having alternatives that are not ethically conflicted with foetal cell lines is not just an ethical issue — it’s a public health issue.”

Safety Assumed, Not Proven

When the discussion turned to safety, Siri asked, “Are you aware of any study that compares vaccinated children to completely unvaccinated children?”

Plotkin replied that he was “not aware of well-controlled studies.”

Asked why no placebo-controlled trials had been conducted on routine childhood vaccines such as hepatitis B, Plotkin said such trials would be “ethically difficult.”

That rationale, Siri noted, creates a scientific blind spot. If trials are deemed too unethical to conduct, then gold-standard safety data — the kind required for other pharmaceuticals — simply do not exist for the full childhood vaccine schedule.

Siri pointed to one example: Merck’s hepatitis B vaccine, administered to newborns. The company had only monitored participants for adverse events for five days after injection.

Plotkin didn’t dispute it. “Five days is certainly short for follow-up,” he admitted, but claimed that “most serious events” would occur within that time frame.

Siri challenged the idea that such a narrow window could capture meaningful safety data — especially when autoimmune or neurodevelopmental effects could take weeks or months to emerge.

Siri pushed on. He asked Plotkin if the DTaP and Tdap vaccines — for diphtheria, tetanus and pertussis — could cause autism.

“I feel confident they do not,” Plotkin replied.

But when shown the Institute of Medicine’s 2011 report, which found the evidence “inadequate to accept or reject” a causal link between DTaP and autism, Plotkin countered, “Yes, but the point is that there were no studies showing that it does cause autism.”

In that moment, Plotkin embraced a fallacy: treating the absence of evidence as evidence of absence.

“You’re making assumptions, Dr Plotkin,” Siri challenged. “It would be a bit premature to make the unequivocal, sweeping statement that vaccines do not cause autism, correct?”

Plotkin relented. “As a scientist, I would say that I do not have evidence one way or the other.”

The MMR

The deposition also exposed the fragile foundations of the measles, mumps, and rubella (MMR) vaccine.

When Siri asked for evidence of randomised, placebo-controlled trials conducted before MMR’s licensing, Plotkin pushed back: “To say that it hasn’t been tested is absolute nonsense,” he said, claiming it had been studied “extensively.”

Pressed to cite a specific trial, Plotkin couldn’t name one. Instead, he gestured to his own 1,800-page textbook: “You can find them in this book, if you wish.”

Siri replied that he wanted an actual peer-reviewed study, not a reference to Plotkin’s own book. “So you’re not willing to provide them?” he asked. “You want us to just take your word for it?”

Plotkin became visibly frustrated.

Eventually, he conceded there wasn’t a single randomised, placebo-controlled trial. “I don’t remember there being a control group for the studies, I’m recalling,” he said.

The exchange foreshadowed a broader shift in public discourse, highlighting long-standing concerns that some combination vaccines were effectively grandfathered into the schedule without adequate safety testing.

In September this year, President Trump called for the MMR vaccine to be broken up into three separate injections.

The proposal echoed a view that Andrew Wakefield had voiced decades earlier — namely, that combining all three viruses into a single shot might pose greater risk than spacing them out.

Wakefield was vilified and struck from the medical register. But now, that same question — once branded as dangerous misinformation — is set to be re-examined by the CDC’s new vaccine advisory committee, chaired by Martin Kulldorff.

The Aluminium Adjuvant Blind Spot

Siri next turned to aluminium adjuvants — the immune-activating agents used in many childhood vaccines.

When asked whether studies had compared animals injected with aluminium to those given saline, Plotkin conceded that research on their safety was limited.

Siri pressed further, asking if aluminium injected into the body could travel to the brain. Plotkin replied, “I have not seen such studies, no, or not read such studies.”

When presented with a series of papers showing that aluminium can migrate to the brain, Plotkin admitted he had not studied the issue himself, acknowledging that there were experiments “suggesting that that is possible.”

Asked whether aluminium might disrupt neurological development in children, Plotkin stated, “I’m not aware that there is evidence that aluminum disrupts the developmental processes in susceptible children.”

Taken together, these exchanges revealed a striking gap in the evidence base.

Compounds such as aluminium hydroxide and aluminium phosphate have been injected into babies for decades, yet no rigorous studies have ever evaluated their neurotoxicity against an inert placebo.

This issue returned to the spotlight in September 2025, when President Trump pledged to remove aluminium from vaccines, and world-leading researcher Dr Christopher Exley renewed calls for its complete reassessment.

A Broken Safety Net

Siri then turned to the reliability of the Vaccine Adverse Event Reporting System (VAERS) — the primary mechanism for collecting reports of vaccine-related injuries in the United States.

Did Plotkin believe most adverse events were captured in this database?

“I think…probably most are reported,” he replied.

But Siri showed him a government-commissioned study by Harvard Pilgrim, which found that fewer than 1% of vaccine adverse events are reported to VAERS.

“Yes,” Plotkin said, backtracking. “I don’t really put much faith into the VAERS system…”

Yet this is the same database officials routinely cite to claim that “vaccines are safe.”

Ironically, Plotkin himself recently co-authored a provocative editorial in the New England Journal of Medicineconceding that vaccine safety monitoring remains grossly “inadequate.”

Experimenting on the Vulnerable

Perhaps the most chilling part of the deposition concerned Plotkin’s history of human experimentation.

“Have you ever used orphans to study an experimental vaccine?” Siri asked.

“Yes,” Plotkin replied.

“Have you ever used the mentally handicapped to study an experimental vaccine?” Siri asked.

“I don’t recollect…I wouldn’t deny that I may have done so,” Plotkin replied.

Siri cited a study conducted by Plotkin in which he had administered experimental rubella vaccines to institutionalised children who were “mentally retarded.”

Plotkin stated flippantly, “Okay well, in that case…that’s what I did.”

There was no apology, no sign of ethical reflection — just matter-of-fact acceptance.

Siri wasn’t done.

He asked if Plotkin had argued that it was better to test on those “who are human in form but not in social potential” rather than on healthy children.

Plotkin admitted to writing it.

Siri established that Plotkin had also conducted vaccine research on the babies of imprisoned mothers, and on colonised African populations.

Plotkin appeared to suggest that the scientific value of such studies outweighed the ethical lapses—an attitude that many would interpret as the classic ‘ends justify the means’ rationale.

But that logic fails the most basic test of informed consent. Siri asked whether consent had been obtained in these cases.

“I don’t remember…but I assume it was,” Plotkin said.

Assume?

This was post-Nuremberg research. And the leading vaccine developer in America couldn’t say for sure whether he had properly informed the people he experimented on.

In any other field of medicine, such lapses would be disqualifying.

A Casual Dismissal of Parental Rights

Plotkin’s indifference to experimenting on disabled children didn’t stop there.

Siri asked whether someone who declined a vaccine due to concerns about missing safety data should be labelled “anti-vax.”

Plotkin replied, “If they refused to be vaccinated themselves or refused to have their children vaccinated, I would call them an anti-vaccination person, yes.”

Plotkin was less concerned about adults making that choice for themselves, but he had no tolerance for parents making those choices for their own children.

“The situation for children is quite different,” said Plotkin, “because one is making a decision for somebody else and also making a decision that has important implications for public health.”

In Plotkin’s view, the state held greater authority than parents over a child’s medical decisions — even when the science was uncertain.

The Enabling of Figures Like Plotkin

The Plotkin deposition stands as a case study in how conflicts of interest, ideology, and deference to authority have corroded the scientific foundations of public health.

Plotkin is no fringe figure. He is celebrated, honoured, and revered. Yet he promotes vaccines that have never undergone true placebo-controlled testing, shrugs off the failures of post-market surveillance, and admits to experimenting on vulnerable populations.

This is not conjecture or conspiracy — it is sworn testimony from the man who helped build the modern vaccine program.

Now, as Health Secretary Robert F. Kennedy, Jr. reopens long-dismissed questions about aluminium adjuvants and the absence of long-term safety studies, Plotkin’s once-untouchable legacy is beginning to fray.

Republished from the author’s Substack

Maryanne Demasi

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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Brownstone Institute

Bizarre Decisions about Nicotine Pouches Lead to the Wrong Products on Shelves

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From the Brownstone Institute

  Roger Bate  

A walk through a dozen convenience stores in Montgomery County, Pennsylvania, says a lot about how US nicotine policy actually works. Only about one in eight nicotine-pouch products for sale is legal. The rest are unauthorized—but they’re not all the same. Some are brightly branded, with uncertain ingredients, not approved by any Western regulator, and clearly aimed at impulse buyers. Others—like Sweden’s NOAT—are the opposite: muted, well-made, adult-oriented, and already approved for sale in Europe.

Yet in the United States, NOAT has been told to stop selling. In September 2025, the Food and Drug Administration (FDA) issued the company a warning letter for offering nicotine pouches without marketing authorization. That might make sense if the products were dangerous, but they appear to be among the safest on the market: mild flavors, low nicotine levels, and recyclable paper packaging. In Europe, regulators consider them acceptable. In America, they’re banned. The decision looks, at best, strange—and possibly arbitrary.

What the Market Shows

My October 2025 audit was straightforward. I visited twelve stores and recorded every distinct pouch product visible for sale at the counter. If the item matched one of the twenty ZYN products that the FDA authorized in January, it was counted as legal. Everything else was counted as illegal.

Two of the stores told me they had recently received FDA letters and had already removed most illegal stock. The other ten stores were still dominated by unauthorized products—more than 93 percent of what was on display. Across all twelve locations, about 12 percent of products were legal ZYN, and about 88 percent were not.

The illegal share wasn’t uniform. Many of the unauthorized products were clearly high-nicotine imports with flashy names like Loop, Velo, and Zimo. These products may be fine, but some are probably high in contaminants, and a few often with very high nicotine levels. Others were subdued, plainly meant for adult users. NOAT was a good example of that second group: simple packaging, oat-based filler, restrained flavoring, and branding that makes no effort to look “cool.” It’s the kind of product any regulator serious about harm reduction would welcome.

Enforcement Works

To the FDA’s credit, enforcement does make a difference. The two stores that received official letters quickly pulled their illegal stock. That mirrors the agency’s broader efforts this year: new import alerts to detain unauthorized tobacco products at the border (see also Import Alert 98-06), and hundreds of warning letters to retailers, importers, and distributors.

But effective enforcement can’t solve a supply problem. The list of legal nicotine-pouch products is still extremely short—only a narrow range of ZYN items. Adults who want more variety, or stores that want to meet that demand, inevitably turn to gray-market suppliers. The more limited the legal catalog, the more the illegal market thrives.

Why the NOAT Decision Appears Bizarre

The FDA’s own actions make the situation hard to explain. In January 2025, it authorized twenty ZYN products after finding that they contained far fewer harmful chemicals than cigarettes and could help adult smokers switch. That was progress. But nine months later, the FDA has approved nothing else—while sending a warning letter to NOAT, arguably the least youth-oriented pouch line in the world.

The outcome is bad for legal sellers and public health. ZYN is legal; a handful of clearly risky, high-nicotine imports continue to circulate; and a mild, adult-market brand that meets European safety and labeling rules is banned. Officially, NOAT’s problem is procedural—it lacks a marketing order. But in practical terms, the FDA is punishing the very design choices it claims to value: simplicity, low appeal to minors, and clean ingredients.

This approach also ignores the differences in actual risk. Studies consistently show that nicotine pouches have far fewer toxins than cigarettes and far less variability than many vapes. The biggest pouch concerns are uneven nicotine levels and occasional traces of tobacco-specific nitrosamines, depending on manufacturing quality. The serious contamination issues—heavy metals and inconsistent dosage—belong mostly to disposable vapes, particularly the flood of unregulated imports from China. Treating all “unauthorized” products as equally bad blurs those distinctions and undermines proportional enforcement.

My small Montgomery County survey suggests a simple formula for improvement.

First, keep enforcement targeted and focused on suppliers, not just clerks. Warning letters clearly change behavior at the store level, but the biggest impact will come from auditing distributors and importers, and stopping bad shipments before they reach retail shelves.

Second, make compliance easy. A single-page list of authorized nicotine-pouch products—currently the twenty approved ZYN items—should be posted in every store and attached to distributor invoices. Point-of-sale systems can block barcodes for anything not on the list, and retailers could affirm, once a year, that they stock only approved items.

Third, widen the legal lane. The FDA launched a pilot program in September 2025 to speed review of new pouch applications. That program should spell out exactly what evidence is needed—chemical data, toxicology, nicotine release rates, and behavioral studies—and make timely decisions. If products like NOAT meet those standards, they should be authorized quickly. Legal competition among adult-oriented brands will crowd out the sketchy imports far faster than enforcement alone.

The Bottom Line

Enforcement matters, and the data show it works—where it happens. But the legal market is too narrow to protect consumers or encourage innovation. The current regime leaves a few ZYN products as lonely legal islands in a sea of gray-market pouches that range from sensible to reckless.

The FDA’s treatment of NOAT stands out as a case study in inconsistency: a quiet, adult-focused brand approved in Europe yet effectively banned in the US, while flashier and riskier options continue to slip through. That’s not a public-health victory; it’s a missed opportunity.

If the goal is to help adult smokers move to lower-risk products while keeping youth use low, the path forward is clear: enforce smartly, make compliance easy, and give good products a fair shot. Right now, we’re doing the first part well—but failing at the second and third. It’s time to fix that.

Author

Roger Bate

Roger Bate is a Brownstone Fellow, Senior Fellow at the International Center for Law and Economics (Jan 2023-present), Board member of Africa Fighting Malaria (September 2000-present), and Fellow at the Institute of Economic Affairs (January 2000-present).

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