FDA-Led Peer-Reviewed Study by High School Students Uncovers Alarming DNA Contamination in Pfizer’s mRNA COVID-19 Vaccine at FDA’s Own Lab.
A group of high school students from Centreville High School in Virginia, in collaboration with the FDA, has uncovered alarming DNA contamination in both Pfizer’s experimental and commercial mRNA COVID-19 shots.
Their peer-reviewed study, published in the Journal of High School Science on December 29th, has sparked renewed debate over vaccine manufacturing standards and quality control processes.
The researchers, led by Tyler Wang, Alex Kim, and Kevin Kim, developed a novel method to detect replication-competent DNA impurities at FDA’s own research facility at the White Oak Campus, Children’s Health Defense reported.
Their technique involves extracting DNA from vaccine samples, ligating it into a circular form, and then transforming it into Escherichia coli cells.
If transformation results in antibiotic-resistant bacterial colonies, it indicates the presence of replication-competent DNA, which should ideally be absent or minimal in the final vaccine product.
The findings were based on analyses of two separate lots of Pfizer’s mRNA vaccines, including monovalent and bivalent formulations.
The students uncovered significant levels of DNA contamination in the vaccines, with some samples exceeding the WHO threshold by up to 470 times, the amount of residual DNA detected ranged between 40 to 110 nanograms per dose.
While no replication-competent DNA was detected in commercial Pfizer vaccine batches, smaller DNA fragments—approximately 35 base pairs in length—were consistently present.
Interestingly, the study reported sporadic instances of replication-competent DNA in an in-house mRNA vaccine and a biosimilar vaccine.
Investigative medical reporter, Maryanne Demasi, Ph.D. first reported:
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.”
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.
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.”
This first appeared in The Defender, and Gateway Pundit.