In a recent preprint study currently undergoing peer review, researchers have discovered substantial amounts of residual DNA fragments in COVID-19 mRNA vaccine vials. Molecular virologist David Speicher, the lead author of the study and a Ph.D. holder in virology, emphasized that their investigation is the most extensive examination of residual DNA in COVID-19 vaccines to date.
The study focused on measuring DNA copies of spike, ori (origin of replication), and SV40 enhancer genes. According to Speicher, the loads of SV40 enhancer-promoter, ori, and virus spike in Pfizer vaccines reached up to 186 billion copies per dose. The spike refers to the DNA sequence of the SARS-CoV-2 spike protein, crucial for the mRNA vaccines.
Despite the intended composition of mRNA vaccines being solely RNA, the researchers sequenced the genetic material in 27 mRNA vaccine vials from 12 different lots, revealing billions of residual DNA fragments. Nineteen vials were from Moderna, and eight were from Pfizer.
The presence of DNA in mRNA vaccines stems from the initial production process. Pfizer initially planned to use a PCR machine to generate DNA for the mRNA vaccines, but due to time constraints, switched to using bacteria to mass-produce spike DNA. Moderna also employed plasmid DNA in their vaccine production.
The concern arises because the final vaccines are supposed to include only RNA, with any residual DNA to be removed. However, the study found inefficient clearance of DNA, leading to billions of copies of spike, ori, and SV40 enhancer DNA in Pfizer vials, and millions in Moderna vials.
Foreign DNA in conjunction with mRNA in the vaccines raises the risk of integration into the human genome, potentially causing long-term health implications, including cancer. The SV40 enhancer gene, in particular, is controversial due to its association with a virus linked to cancer.
The study suggested a potential link between vials with higher DNA content and adverse reactions, as seen in reports on the Vaccine Adverse Reaction Reports System (VAERS). Vials with higher DNA doses, often requiring dilution, may lead to incorrect dosing if not properly administered.
The research team used fluorometry and qPCR to assess DNA content dosage. While fluorometry indicated levels far exceeding FDA limits, qPCR suggested compliance with standards. The discrepancy highlights the need for further research and standardization of testing methods.
Kevin McKernan, a study author with extensive genomic sequencing experience, emphasized the necessity for additional research to understand the impact of DNA contamination in COVID-19 vaccines. Unanswered questions include the potential triggering of cancer by the SV40 sequence and the immune response to residual DNA, necessitating further animal studies.
Despite concerns raised by experts, regulatory bodies like the FDA and the European Medicines Agency have not recalled the vaccines, emphasizing the need for continued investigation and scrutiny into DNA contamination in COVID-19 vaccines.