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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