Maryanne Demasi, PhD

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.

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 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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A few days ago, the study titled Evaluation of post-COVID mortality risk in cases classified as severe acute respiratory syndrome in Brazil: a longitudinal study for medium and long term was published in Frontiers in Medicine:

Background: There are few studies in the literature evaluating post-COVID mortality in Brazil, along medium and long term, especially in those who presented severe clinical disease.

Objective: This study aims to investigate the factors associated with post-COVID mortality of severe acute respiratory syndrome (SARS) cases from 2020 to 2023 in Brazil, along medium and long term.

Methods: Retrospective cohort study using notification data of SARS classified as COVID-19 from the Brazilian National Information System, “Sistema de Vigilância Epidemiológica (SIVEP),” during the period 2020 to 2023. Data included demographics, comorbidities, vaccination status, number of COVID-19 vaccine doses, city of residence, and survival outcomes. Classic Cox, Cox mixed effects, and Cox fragility models were used to assess medium and long-term risks of dying post-COVID.

Results: In the medium and long-term periods studied, 5,157 deaths were recorded out of 15,147 reported SARS/COVID-19 cases. Of these deaths, 91.5% (N = 4,720) occurred within the first year, while 8,5% (N = 437) after the first year. People without formal education, the older adult, had higher percentages of deaths in both periods. In the medium-term post-COVID period, the risk of death was reduced by 8% for those who had been vaccinated while in the long-term post-COVID period, the risk of death almost doubled for those who had been vaccinated. While in the medium term, there was a reduction in mortality risk for those who took two or three doses, in the long term the risk of death was greater for those who took one or two doses.

Conclusion: The protective effect of COVID-19 immunization was observed up to one year after the first symptoms. After one year, the effect was reversed, showing an increased risk of death for those vaccinated. These results highlight the need for further research to elucidate the factors that contribute to these findings.

As illustrated in the Kaplan Meier survival curves, over the long-term, those that refused COVID-19 injections were less likely to die compared to vaccinated individuals. While vaccination initially reduced post-COVID mortality risk in the medium term, this protective effect completely reversed in the long term, ultimately doubling the risk of death​.

The authors said that the ‘protective effect’ in the medium term could have been due to the following factors:

(1) Vaccination may be associated with healthier behaviors or greater health awareness. For example, vaccinated individuals may be more likely to follow other public health recommendations, such as staying up-to-date with preventive health measures, having regular medical check-ups, or adopting healthier lifestyles. This could lead to a reduction in the risk of death from other causes in the medium term.

(2) Access to healthcare – since people with comorbidities were prioritized for COVID-19 immunization, these populations may also have benefited from increased medical monitoring and access to healthcare, which may have contributed to a reduction in the risk of death from other causes.

The authors then gave possible reasons behind the complete reversal to doubling the risk of death in the long-term:

(1) Adverse effects of the vaccines – while COVID-19 vaccines have proven to be safe for the vast majority of people, there are concerns about potential long term adverse effects (although rare), such as myocarditis, thrombosis, or other rare conditions associated with vaccination. These effects may be more pronounced in some groups, particularly in more vulnerable individuals, which could contribute to an increased risk of death from other causes over time;

(2) The COVID-19 vaccine may have an indirect effect on the immune system – for people with pre-existing conditions or those with weakened immune systems (such as patients with autoimmune diseases or those on immunosuppressive treatments), the immune response to the virus may have unexpected or complex effects that increase vulnerability to other infections or lead to complications of pre-existing conditions.

This study corroborates Alessandria et al, who found that COVID-19 ‘vaccination’ reduced life expectancy by 37% and increased all-cause death risks during the 2-year follow-up period:

These data help explain why at least 17 million people may have died from COVID-19 ‘vaccination’ as demonstrated by Rancourt et al. Life-reducing injections should NOT be recommended for anyone and must be immediately removed from global markets to safeguard the public from further injury and death.

In the United States, COVID-19 genetic injections are estimated to have caused more deaths than American casualties in WWI and WWII combined. The death toll even rivals the scale of the Civil War. This is a profound national tragedy, and accountability is urgently warranted.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org