A group of high school students from Centreville High School in Virginia, working in collaboration with the FDA, has made a startling discovery regarding DNA contamination in Pfizer’s mRNA COVID-19 vaccines. Their peer-reviewed research, published on December 29 in the Journal of High School Science, has reignited discussions about vaccine manufacturing standards and quality control.
Led by Tyler Wang, Alex Kim, and Kevin Kim, the students developed a unique method to detect replication-competent DNA impurities. The research took place at the FDA’s White Oak Campus. According to Children’s Health Defense, the students’ method involved extracting DNA from vaccine samples, converting it into a circular form, and transforming it into Escherichia coli. Antibiotic-resistant bacterial colonies indicated the presence of replication-competent DNA—something ideally absent in the final vaccine product.
The study examined two separate lots of Pfizer’s mRNA vaccines, including both monovalent and bivalent formulations. Alarmingly, DNA contamination levels ranged from 40 to 110 nanograms per dose, exceeding the WHO threshold by up to 470 times. Smaller DNA fragments (approximately 35 base pairs in length) were consistently present, though no replication-competent DNA was found in commercial vaccine samples. However, sporadic instances of such DNA were identified in an in-house mRNA vaccine and a biosimilar product.
Kevin McKernan, a former Human Genome Project director, described the findings as a “bombshell,” criticizing the FDA for lack of transparency. “Why has the FDA kept these data under wraps?” he asked. McKernan also pointed out potential limitations in the study’s methodology, noting that the Qubit analysis and Plasmid Prep kits might underestimate contamination levels.
Immunology professor Nikolai Petrovsky called the findings a “smoking gun” and emphasized the significance of the students’ contributions. “It clearly shows the FDA was aware of these data. Given these studies were conducted in their own labs under their supervision, it would be hard to argue they were unaware.” Praising the students’ efforts, he remarked, “The irony is striking. These students performed essential work that regulators failed to do.”
This isn’t the first time concerns about vaccine contamination have been raised. In 2023, Florida Surgeon General Dr. Joseph A. Ladapo called for greater transparency regarding potential DNA integration risks from Pfizer and Moderna mRNA vaccines. He highlighted the potential hazards of lipid nanoparticles combined with DNA contaminants like the SV40 promoter/enhancer, which could facilitate DNA integration into human genomes.
Concerns about mRNA vaccines’ genomic impact were echoed in a 2022 Swedish study published in the Journal of Clinical Medicine. Researchers found that Pfizer’s mRNA vaccine can reverse-transcribe into DNA and integrate into human liver cell genomes within six hours. The study noted, “Our study shows that BNT162b2 can be reverse transcribed to DNA in liver cell line Huh7,” potentially causing “genotoxic side effects.”
This growing body of research calls for enhanced scrutiny of mRNA vaccine manufacturing processes and transparency in reporting any potential risks to public health.
