Published on September 6, 2025, in the journal Autoimmunity, this paper, submitted as evidence in the Congressional Record by Senator Ron Johnson (R-WI) on September 9, 2025, investigates the presence of residual plasmid DNA and SV40 promoter-enhancer sequences in Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines. The study tested 32 vials from 16 unique lots using qPCR and fluorometry with RNase A digestion to accurately measure DNA levels, revealing significant findings that challenge claims by regulatory bodies like the CDC, FDA, and HHS regarding vaccine safety and biodistribution. The results show DNA levels exceeding regulatory thresholds, the presence of SV40 promoter-enhancer sequences in Pfizer vials, and potential risks of genomic integration and cancer pathway activation due to lipid nanoparticle (LNP)-encapsulated DNA. The study calls for updated regulatory guidelines, transparent safety testing, and adherence to the precautionary principle.
DNA Contamination Found: All tested Pfizer and Moderna vaccine vials contained residual plasmid DNA, with levels 36–627 times higher than the FDA/WHO limit of 10 ng/dose, measured using fluorometry with RNase A digestion to eliminate RNA interference.
SV40 Promoter-Enhancer in Pfizer Vials: SV40 sequences, a gene therapy tool that facilitates nuclear transport, were detected in Pfizer but not Moderna vials, raising concerns about potential genomic integration and cancer pathway activation (e.g., cGas-STING, p53 interaction).
Inadequate Regulatory Testing: Manufacturers and regulators used single-method testing (qPCR or fluorometry), which is prone to errors due to cross-reactivity. The study’s dual-method approach ensured accurate DNA quantification.
Process 2 Concerns: Commercial vaccines used a plasmid/E. coli system (Process 2) for rapid DNA production, unlike the PCR-based Process 1 used in clinical trials. Inadequate purification led to DNA impurities and potential lipopolysaccharide (LPS) contamination, linked to anaphylaxis reports in VAERS (10,911 cases).
Biodistribution Misrepresentation: Claims that LNPs remain in the injection site are false, as LNPs are designed for systemic distribution, a fact known to regulators.
Regulatory Thresholds Outdated: The 10 ng/dose limit is based on naked DNA, not LNP-encapsulated DNA, which is more efficient at transfection and requires stricter guidelines.
Call for Action: The study urges replication under forensic conditions, revised guidelines for LNP-based vaccines, transparent safety data, and adherence to the precautionary principle to address risks of genomic damage and long-term health effects.
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