Pfizer-BioNTech’s detection methods for residual DNA are massively inaccurate, according to a new study
Genetic impurities in the Pfizer mRNA COVID vaccine could be as high as 500 times the permissible limit, according to a new study.
In the study, published in Methods and Protocols, two German researchers raise worrying questions about the reliability of the quantitative PCR technique used by Pfizer-BioNTech to measure DNA contamination in the vaccine.
Using their own tests on the vaccine’s lipid nanoparticles, they discovered levels that were between 360 and 534 times higher than the 10 nanogram per dose limit set by regulators.
The researchers argued that the methods used by Pfizer-BioNTech test for only 1% of the original DNA template used to make the vaccine, meaning that 99% of the genetical material from the template therefore goes untested and potentially undetected.
Similar concerns have been raised by other researchers.
DNA contamination could have a wide range of harmful effects. DNA fragments could be taken up into the genome and disrupt normal gene sequences, leading to mutations and cancer, otherwise known as “insertional mutagenesis.”
The possibility of insertional mutagenesis is acknowledged in the patent for Moderna’s COVID-19 vaccine.
The patent states DNA contamination could cause cancer: “The DNA template used in the mRNA manufacturing process must be removed to ensure the efficacy of therapeutics and safety, because residual DNA in drug products may induce activation of the innate response and has the potential to be oncogenic in patient populations.”
It had already been discovered that DNA in the mRNA COVID vaccines includes a variety of leftover genetic material, including the simian virus 40 cancer-promoting gene and plasmid DNA sequences from E.coli.
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