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COVID-19

FDA lab uncovers excess DNA contamination in COVID-19 vaccines

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8 minute read

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, AustraliaGermany 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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COVID-19

Study finds Pfizer COVID vaccine poses 37% greater mortality risk than Moderna

Published on

From LifeSiteNews

By Nicolas Hulscher, MPH

A study of 1.47 million Florida adults by MIT’s Retsef Levi and Surgeon General Joseph Ladapo finds significantly higher all-cause mortality after Pfizer vaccination compared to Moderna

A new study of 1.47 million Florida adults by MIT’s Retsef Levi and Surgeon General Joseph Ladapo finds significantly higher all-cause, cardiovascular, and COVID-19 mortality after Pfizer vaccination.

The study titled “Twelve-Month All-Cause Mortality after Initial COVID-19 Vaccination with Pfizer-BioNTech or mRNA-1273 among Adults Living in Florida” was just uploaded to the MedRxiv preprint server. This study was headed by MIT Professor Retsef Levi, with Florida Surgeon General Dr. Joseph Ladapo serving as senior author:

Study Overview

  • Population: 1,470,100 noninstitutionalized Florida adults (735,050 Pfizer recipients and 735,050 Moderna recipients).
  • Intervention: Two doses of either:
    • BNT162b2 (Pfizer-BioNTech)
    • mRNA-1273 (Moderna)
  • Follow-up Duration: 12 months after second dose.
  • Comparison: Head-to-head between Pfizer vs. Moderna recipients.
  • Main Outcomes:
    • All-cause mortality
    • Cardiovascular mortality
    • COVID-19 mortality
    • Non-COVID-19 mortality

All-cause mortality

Pfizer recipients had a significantly higher 12-month all-cause death rate than Moderna recipients — about 37% higher risk.

  • Pfizer Risk: 847.2 deaths per 100,000 people
  • Moderna Risk: 617.9 deaths per 100,000 people
  • Risk Difference:
    ➔ +229.2 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.37 (i.e., 37% higher mortality risk with Pfizer)
  • Odds Ratio (Adjusted):
    ➔ 1.384 (95% CI: 1.331–1.439)

Cardiovascular mortality

Pfizer recipients had a 53% higher risk of dying from cardiovascular causes compared to Moderna recipients.

  • Pfizer Risk: 248.7 deaths per 100,000 people
  • Moderna Risk: 162.4 deaths per 100,000 people
  • Risk Difference:
    ➔ +86.3 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.53 (i.e., 53% higher cardiovascular mortality risk)
  • Odds Ratio (Adjusted):
    ➔ 1.540 (95% CI: 1.431–1.657)

COVID-19 mortality

Pfizer recipients had nearly double the risk of COVID-19 death compared to Moderna recipients.

  • Pfizer Risk: 55.5 deaths per 100,000 people
  • Moderna Risk: 29.5 deaths per 100,000 people
  • Risk Difference:
    ➔ +26.0 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.88 (i.e., 88% higher COVID-19 mortality risk)
  • Odds Ratio (Adjusted):
    ➔ 1.882 (95% CI: 1.596–2.220)

Non-COVID-19 mortality

Pfizer recipients faced a 35% higher risk of dying from non-COVID causes compared to Moderna recipients.

  • Pfizer Risk: 791.6 deaths per 100,000 people
  • Moderna Risk: 588.4 deaths per 100,000 people
  • Risk Difference:
    ➔ +203.3 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.35 (i.e., 35% higher non-COVID mortality risk)
  • Odds Ratio (Adjusted):
    ➔ 1.356 (95% CI: 1.303–1.412)

Biological explanations

The findings of this study are surprising, given that Moderna’s mRNA-1273 vaccine contains approximately three times more mRNA (100 µg) than Pfizer’s BNT162b2 vaccine (30 µg). This suggests that the higher mortality observed among Pfizer recipients could potentially be related to higher levels of DNA contamination — an issue that has been consistently reported worldwide:

The paper hypothesizes differences between Pfizer and Moderna may be due to:

  • Different lipid nanoparticle compositions
  • Differences in manufacturing, biodistribution, or storage conditions

Final conclusion

Florida adults who received Pfizer’s BNT162b2 vaccine had higher 12-month risks of all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality compared to Moderna’s mRNA-1273 vaccine recipients.

Unfortunately, without an unvaccinated group, the study cannot determine the absolute increase in mortality risk attributable to mRNA vaccination itself. However, based on the mountain of existing evidence, it is likely that an unvaccinated cohort would have experienced much lower mortality risks. It’s also important to remember that Moderna mRNA injections are still dangerous.

As the authors conclude:

These findings are suggestive of differential non-specific effects of the BNT162b2 and mRNA-1273 COVID-19 vaccines, and potential concerning adverse effects on all-cause and cardiovascular mortality. They underscore the need to evaluate vaccines using clinical endpoints that extend beyond their targeted diseases.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

Please consider following both the McCullough Foundation and my personal accounton X (formerly Twitter) for further content.

Reprinted with permission from Focal Points.

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COVID-19

Canada’s health department warns COVID vaccine injury payouts to exceed $75 million budget

Published on

Fr0m LifeSiteNews

By Clare Marie Merkowsky

A Department of Health memo warns that Canada’s Vaccine Injury Support Program will exceed its $75 million budget due to high demand, with $16 million already paid out.

COVID vaccine injury payments are expected to go over budget, according to a Canadian Department of Health memo.

According to information published April 28 by Blacklock’s Reporter, the Department of Health will exceed their projected payouts for COVID vaccine injuries, despite already spending $16 million on compensating those harmed by the once-mandated experimental shots.

“A total $75 million in funding has been earmarked for the first five years of the program and $9 million on an ongoing basis,” the December memo read. “However the overall cost of the program is dependent on the volume of claims and compensation awarded over time, and that the demand remains at very high levels.”

“The purpose of this funding is to ensure people in Canada who experience a serious and permanent injury as a result of receiving a Health Canada authorized vaccine administered in Canada on or after December 8, 2020 have access to a fair and timely financial support mechanism,” it continued.

Canada’s Vaccine Injury Support Program (VISP) was launched in December 2020 after the Canadian government gave vaccine makers a shield from liability regarding COVID-19 jab-related injuries.

While Parliament originally budgeted $75 million, thousands of Canadians have filed claims after received the so-called “safe and effective” COVID shots. Of the 3,060 claims received to date, only 219 had been approved so far, with payouts totaling over $16 million.

Since the start of the COVID crisis, official data shows that the virus has been listed as the cause of death for less than 20 kids in Canada under age 15. This is out of six million children in the age group.

The COVID jabs approved in Canada have also been associated with severe side effects such as blood clots, rashes, miscarriages, and even heart attacks in young, healthy men.

Additionally, a recent study done by researchers with Canada-based Correlation Research in the Public Interest showed that 17 countries have found a “definite causal link” between peaks in all-cause mortality and the fast rollouts of the COVID shots as well as boosters.

Interestingly, while the Department of Health has spent $16 million on injury payouts, the Liberal government spent $54 million COVID propaganda promoting the vaccine to young Canadians.

The Public Health Agency of Canada especially targeted young Canadians ages 18-24 because they “may play down the seriousness of the situation.”

The campaign took place despite the fact that the Liberal government knew about COVID vaccine injuries, according to a secret memo.

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