COVID-19
Calls for COVID-19 vaccine recall – FDA’s own study finds DNA contamination in Pfizer vaccines
From LifeSiteNews
By Dr. Michael Nevradakis for The Defender
“It is alarming that the public is made aware of this contamination in an obscure journal that features high school science research. One has to ask, ‘Where is the FDA now?’ and ‘Why hasn’t the public been alerted of this?’”
The peer-reviewed study in the Journal of High School Science was authored by three high school students and performed at an FDA lab under the supervision of FDA scientists. The findings prompted renewed calls for a moratorium on COVID-19 vaccines.
A peer-reviewed study performed at a U.S. Food and Drug Administration (FDA) laboratory by high school students has confirmed the presence of a high level of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.
The study, published December 29, 2024, in the Journal of High School Science, was authored by three students at Centreville High School in Clifton, Virginia, and performed under the supervision of FDA scientists.
Maryanne Demasi, Ph.D., an investigative medical reporter, was the first to report on the study.
READ: British doctor has medical license revoked over warning of COVID shot dangers
The research, performed at the FDA’s White Oak Campus in Maryland, found that levels of residual DNA in the Pfizer COVID-19 vaccine were 6 to 470 times higher than regulatory safety limits. The students tested two lots of the vaccine, finding they contained “residual DNA to a level that exceeds 10 ng [nanograms] per dose.”
“The potential health risk posed by residual small DNA fragments is currently unknown,” the study stated. However, the authors also said that DNA contamination may result in insertional mutagenesis – or DNA mutations – that can cause cancer.
Speaking last month on “The Defender In-Depth,” Kevin McKernan, who first identified DNA contamination in the shots in 2023, said DNA in vaccines can pose health risks because the DNA “could integrate into the genome and cause disruption of the genome … or it could disrupt other genes that are related to cancer.”
The FDA did not respond to multiple requests for comment on the study.
COVID vaccines ‘must be immediately recalled’
The new findings challenge “years of dismissals by regulatory authorities, who had previously labelled concerns about excessive DNA contamination as baseless,” Demasi wrote on Substack.
The findings also align with earlier reports from independent laboratories in the U.S., Canada, Australia, Germany, and France, she said.
McKernan, founder of Medicinal Genomics, told The Defender that eight studies have found DNA over the limit. “Very few studies are surveying a large number of lots, so each study is additive,” he said.
Epidemiologist Nicolas Hulscher said that in “light of this evidence, the COVID-19 genetic injections must be immediately recalled, to protect the public from further harm.”
Nikolai Petrovsky, Ph.D., director of biotechnology company Vaxine Pty Ltd., told Demasi that the findings are a “smoking gun” and that the new study “clearly shows the FDA was aware of these data.”
Christof Plothe, D.O., a member of the World Council for Health steering committee, agreed. He said:
So far, the European, Australian, and American health regulatory boards have denied any risks from plasmid DNA contamination in the COVID-19 injections despite nine studies by internationally known research teams.
All teams concluded that this contamination poses an unacceptable risk to three-quarters of the world’s population.… Three teams so far have demonstrated the integration into human cells. To what extent this is happening to everybody who was injected needs to be investigated.
READ: Children who got COVID shots more likely to catch the virus than those who didn’t, study finds
McKernan said that the FDA has long ignored evidence of the dangers posed by mRNA COVID-19 vaccines.
“The criteria for pulling these shots was established long before DNA contamination was first discovered,” he said. “I would hope that evidence of highly variable manufacturing would be grounds for immediate class 1 recall from the FDA. They are currently distracted with performing class 1 recalls on non-lethal hairspray.”
A Class 1 recall involves “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
According to Demasi, “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.”
Plothe noted that Demasi presented evidence of DNA contamination to the FDA in September 2024, asking if the agency had launched an investigation or requested further testing of the mRNA vaccines by their manufacturers.
“Nothing resulted from this request,” Plothe said. “As nine studies have proven this severe contamination and repeated requests to health regulatory boards have not led to any consequence, we must ask about the motive.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), noted the irony of high school students discovering what the FDA has seemingly missed in the four-plus years since the vaccines’ introduction.
“It is ironic that it takes student researchers at the FDA to do the work of the FDA regulators,” Hooker said. “It is alarming that the public is made aware of this contamination in an obscure journal that features high school science research. One has to ask, ‘Where is the FDA now?’ and ‘Why hasn’t the public been alerted of this?’”
Demasi said that the significance of the new study’s findings is that they came from research performed at an FDA facility.
“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,” Demasi wrote. “It also places vaccine manufacturers and regulators in a precarious position.”
This article was originally published by The Defender – Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Brownstone Institute
The Trump Administration Must Bring Moderna to Heel
From the Brownstone Institute
Moderna’s European filing also revealed that the company withheld trial results demonstrating that children under 12 who received the vaccine were ten times more likely than those who received the placebo to suffer “serious side effects.”
Last week, independent journalist Alex Berenson reported that a preschool-aged child died of “cardio-respiratory arrest” after taking a dose of Moderna’s Covid mRNA vaccine during its clinical trials. Despite federal requirements to report all trial information, the company withheld the truth for years as it raked in billions from its Covid shots.
The extent of the cover-up remains unknown, but Moderna, headed by CEO Stéphane Bancel, disregarded federal law requiring companies to report “summary results information, including adverse event information, for specified clinical trials of drug products” to clinicaltrials.gov. The company, not the government, is responsible for posting all results, and failure to report the death of a child constitutes a clear breach of US law, which threatens civil action against any party that “falsifies, conceals, or covers up by any trick, scheme, or device a material fact.”
To this point, pharmaceutical companies have remained largely immune for their role in perpetrating globally-scaled deception resulting in thousands of vaccine injuries and billions in profits. They have enjoyed a liability shield courtesy of the PREP Act, which offers protections for injuries resulting from vaccines; that indemnity, however, does not extend to non-compliance with federal regulations, material misstatements or omissions of fact, or other offenses.
The death of the child only became known because of an obscure European report released last year, which revealed that Moderna has known about the death for over two years while it continues to advertize Covid shots to children as young as six months old.
Moderna’s European filing also revealed that the company withheld trial results demonstrating that children under 12 who received the vaccine were ten times more likely than those who received the placebo to suffer “serious side effects.” Without any evidence, Moderna claimed that the side effects, including the death of a child, were unrelated to the shots.
The incoming Trump administration offers a rare opportunity to hold pharmaceutical companies accountable and to investigate the depth of the cover-up.
The FDA is responsible for enforcing the reporting of vaccine trial results, but recent heads of the agency such as Scott Gottlieb and Robert Califf have been fanatical supporters of Big Pharma. Trump’s choice for FDA, Dr. Marty Makary, presents a stark contrast to his predecessors. Makary has criticized the US Government’s reluctance to acknowledge the role of natural immunity in preventing Covid infection, and he opposed the widespread vaccination of children. He testified to Congress, “In the U.S. we gave thousands of healthy kids myocarditis for no good reason, they were already immune. This was avoidable.”
President-elect Trump has tapped Robert F. Kennedy, Jr., perhaps the most well-known critic of the Covid vaccines, to lead the Department of Health and Human Services, which oversees the FDA. He has named Dr. Jay Bhattacharya, an author of the Great Barrington Declaration, as his choice to head the National Institutes of Health. Further, Senator Ron Johnson (R-WI) told Berenson that he plans to subpoena the FDA once Republicans become the majority party in the Senate this month.
President Trump’s first term was ultimately defined by his failure to fulfill his pledge to “drain the swamp.” A corrupt bureaucracy, personified in many ways by Dr. Anthony Fauci, aided and abetted by advisors like his son-in-law, Jared Kushner, hijacked the president’s agenda. Now, the Trump administration has an unlikely yet monumental opportunity for health reform, which can start on January 20 with an investigation into Moderna’s cover-up.
The Covid response doomed Trump 1.0. Whether one regards this as a monumental error, the betrayal of a president by his advisors, an event beyond the president’s control, or a deeper and more complex plot involving everything and everyone associated with the government, both in the US and around the world, there is no question of the scale of the calamity for the public. The shots are part of that, the capstone failure of a long line of foreshadowing with lockdowns and all that was associated with pre-pharmaceutical interventions. The antidote came not as a cure but, for many, the disease itself.
There must be truth if not justice.
COVID-19
FDA lab uncovers excess DNA contamination in COVID-19 vaccines
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Explosive revelations as a study conducted at FDA’s own lab found residual DNA levels exceeded safety limits by 6 to 470 times. Experts say it’s a ‘smoking gun.’
An explosive new study conducted within the U.S. 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 States, Canada, Australia, Germany and France.
Expert Reaction
Kevin McKernan, a former director of the Human Genome Project, described the findings as a “bombshell,” criticising 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.
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 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.
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