A new study conducted in the U.S. Food and Drug Administration’s (FDA) laboratory reveals radically high levels of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.Tests conducted at the FDA’s White Oak Campus in Maryland showed residual DNA levels exceeded regulatory safety limits by 6 to 470 times.The peer-reviewed study was undertaken by three student researchers under the supervision of FDA scientists. It was published in the Journal of High School Science on December 29, 2024.The student researchers employed NanoDrop Analysis, which uses UV spectrometry to measure the combined levels of DNA and RNA in the vaccine. They also used the more accurate method of Qubit Analysis, which quantifies double-stranded DNA using fluorometric dye.Both methods confirmed the presence of DNA contamination far above permissible thresholds. Such findings align with earlier reports from independent laboratories in the United States, Canada, Australia, Germany and France.The study received attention through the substack of Maryane Demasi, PhD, an investigative journalist who writes for medical journals and former TV presenter for Australian Broadcast Corporation. Kevin McKernan, a former director of the Human Genome Project, told Demasi the study was a “bombshell.”“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 said.According to McKernan, the contamination may be even worse than the studies showed.“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.”McKernan said the contamination suggests vaccine recipients were at a higher risk of cancer due to genome integration and another way. 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.“Repeated exposure to foreign DNA through COVID-19 boosters may amplify this risk over time, creating conditions conducive to cancer development,” McKernan said.The study found traces of the SV40 promoter among the DNA fragments. The authors concluded they could not replicate in humans, but McKernan said the parameters of the study were not adequate to prove that assertion.Nikolai Petrovsky, a Professor of Immunology and director of Vaxine Pty Ltd, told Demasi the findings were 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.Study authors Tyler J Wang, Alex Kim, and Kevin Kim attend Centreville High School in Clifton, Virginia.“The irony is striking” that high schoolers did “essential work” the regulators should have done themselves, Petrovsky said. “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) released its own batch testing results, claiming they met regulatory standards, but Petrovsky said they used the wrong approach.“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.”Petrovsky said the study findings left regulators and manufacturers in a difficult situation.“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.”
