A groundbreaking study from the FDA’s Maryland laboratory facility has revealed concerning levels of DNA contamination in Pfizer’s mRNA COVID-19 vaccine, with measurements showing contamination levels between 6 and 470 times above regulatory limits.
The research, published in the Journal of High School Science, was conducted by student researchers under FDA scientist supervision, using vaccine samples obtained from BEI Resources, an organization connected to the NIAID. The findings challenge previous dismissals of DNA contamination concerns by regulatory bodies.
The research team employed two distinct analytical approaches to measure contamination levels. The first method, NanoDrop Analysis, utilized UV spectrometry to measure combined DNA and RNA levels, though this technique tends to overestimate DNA concentrations. The second, more precise method involved Qubit Analysis, which
specifically measures double-stranded DNA through fluorometric dye technology.
Former Human Genome Project director Kevin McKernan described the findings as a “bombshell” while noting potential limitations in the methodology. He suggested the study might actually underestimate contamination levels, as the Qubit analysis can under-detect DNA by up to 70% when enzymes are used in sample preparation. McKernan also highlighted concerns about the cGAS-STING pathway, warning that repeated exposure to foreign DNA through boosters could potentially increase cancer risk over time.
The discovery of SV40 promoter traces among the DNA fragments has sparked additional debate. While study authors concluded these fragments were “non-replication-competent,” McKernan contested this assertion, arguing that more comprehensive testing would be necessary to confirm their non-functionality.
Professor Nikolai Petrovsky, an immunology expert and director of Vaxine Pty Ltd, characterized the findings as a “smoking gun” that raises questions about regulatory oversight. He praised the student researchers’ work while noting the irony that such crucial testing was performed by students rather than regulators.
The findings present significant challenges for vaccine manufacturers and regulatory bodies. Professor Petrovsky explained that addressing the contamination would require either demonstrating the safety of current DNA levels or completely revising manufacturing processes – the latter option potentially necessitating new clinical trials.
The Australian TGA’s own batch testing results have claimed regulatory compliance, but Petrovsky criticized their methodology as inadequate, suggesting it only examined a limited DNA fragment rather than conducting comprehensive DNA analysis.
The study’s publication in a peer-reviewed journal from an official agency’s laboratory makes these findings difficult to dismiss. It places both manufacturers and regulators in a position where they must address these concerns to maintain public trust. The FDA has yet to issue a public alert or recall affected batches, though they are expected to comment on the findings.
The contamination levels discovered align with previous reports from independent laboratories across multiple countries, including the United States, Canada, Australia, Germany, and France. This
consistency in findings across different facilities adds weight to the study’s conclusions.
This development represents a significant challenge to regulatory authorities’ previous positions on vaccine safety and raises questions about oversight procedures. Both U.S. and Australian regulatory bodies have been contacted for response to these findings, as the scientific community awaits official explanations for how vaccines with such contamination levels were approved for public use.