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Nikhil Prasad  Fact checked by:Thailand Medical News Team Oct 19, 2023  4 months, 2 days, 17 hours, 21 minutes ago

COVID-19 News: DNA Fragments Found In Some COVID-19 Jabs! Manufacturers And Regulatory Agencies Should Urgently Address Public Concerns!

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COVID-19 News: DNA Fragments Found In Some COVID-19 Jabs! Manufacturers And Regulatory Agencies Should Urgently Address Public Concerns!
Nikhil Prasad  Fact checked by:Thailand Medical News Team Oct 19, 2023  4 months, 2 days, 17 hours, 21 minutes ago
COVID-19 News: As the world grapples with the ongoing COVID-19 pandemic, the development and distribution of vaccines have been central to our collective fight against the virus. However, recent revelations have raised concerns about the safety and composition of some COVID-19 vaccines.
 
This COVID-19 News report covers a groundbreaking study conducted by researchers from the University of Guelph in Ontario, Canada, Synechion, Inc. in Dallas, Texas-USA and Medicinal Genomics in the USA that has uncovered the presence of DNA fragments in certain COVID-19 vaccines, particularly those developed by Pfizer/BioNTech and Moderna.The study was just published online the last few hours ago. This discovery has ignited a debate about vaccine safety, the transparency of vaccine manufacturing processes, and the need for regulatory agencies to reassess existing guidelines.
 
The Study's Findings
The research conducted by the collaborative team focused on the presence of DNA fragments in the mRNA-based COVID-19 vaccines. To understand the source of this DNA contamination, it is essential to delve into the manufacturing processes of these vaccines.
 
Both Pfizer/BioNTech and Moderna initially employed a process involving the use of a DNA template for in vitro transcription (IVT) reactions to generate modified RNA (modRNA) for their COVID-19 vaccines. This DNA template was obtained through polymerase chain reaction (PCR) and was later cloned into a bacterial plasmid vector, followed by amplification in Escherichia coli. The DNA template used in this process was different from the original one employed in the clinical trial phase, introducing potential variations in residual DNA content.
 
The study discovered significant levels of plasmid DNA in both Pfizer and Moderna modRNA vaccines through DNA sequencing. The plasmid DNA was found in numerous lots of these vaccines, raising questions about the consistency of residual DNA levels across different batches.
 
Results revealed varying amounts of plasmid DNA per dose, with Pfizer doses containing 0.28 - 4.27 ng/dose and Moderna doses containing 0.01 - 0.34 ng/dose, measured by qPCR. When assessed with Qubit fluorometry, the levels were even higher, with Pfizer doses measuring 1,896 - 3,720 ng/dose and Moderna doses measuring 3,270 - 5,100 ng/dose.
 
The study also detected the SV40 promoter-enhancer-ori sequence in Pfizer vaccines, which was absent in Moderna vaccines. A preliminary analysis suggested a potential dose-response relationship between the amount of DNA per dose and the frequency of serious adverse events (SAEs), with varying trends for Pfizer and Moderna vaccines.
 
Moreover, size distribution analysis indicated that the DNA fragments had a mean length of 214 base pairs and a maximum length of 3.5 kilobases (kb). Importantly, the plasmid DNA was found to be encapsulated in lipid nanoparticles (LNPs), which protect it from nucleases, potentially prolonging its presence in the body.
 
Implications of the Study
The study's findings have far-reaching implications for vaccine safety, regulatory guidelines, and manufacturing transparency. The presence of billions of DNA molecules per dose in these vaccines, as demonstrated by the research, raises concerns about their safety and long-term effects on vaccine recipients.
 
The guidelines set by the US Food and Drug Administration (FDA) and the World Health Organization (WHO) recommend limiting the residual DNA in vaccines to below 10 ng/dose. However, the study shows that all tested vaccines exceeded these guidelines by a substantial margin. This discrepancy between qPCR and fluorometry measurements highlights the importance of methodological consistency when interpreting quantitative guidelines. The differences observed between Pfizer and Moderna products underscore the need for more in-depth research to understand the precise impact of residual DNA on vaccine safety.
 
Furthermore, the study suggests that the guidelines established by regulatory agencies may not be comprehensive enough, especially considering the evolution of vaccine manufacturing processes. These guidelines do not account for the efficient transfection capabilities of LNPs and cumulative dosing of vaccines.
 
Given that some individuals have received more than five doses of COVID-19 vaccines with short intervals, understanding the potential risks of cumulative dosing becomes crucial.
 
The presence of DNA fragments in the vaccines also raises concerns about integration risks, innate immune responses, and prothrombotic effects. Research indicates that small DNA fragments, even as short as 7 base pairs, can pose integration risks. Therefore, it is essential to investigate how these DNA fragments may affect recipients in the long run.
 
Conclusion and Recommendations
The study's findings concerning the presence of DNA fragments in COVID-19 vaccines have ignited a call for greater transparency, further research, and reassessment of regulatory guidelines. These findings underscore the need for rigorous safety testing and ongoing monitoring of vaccines, especially as manufacturing processes evolve.
 
To address these concerns, it is recommended that:
 
-Regulatory agencies, including the FDA and WHO, revisit and update existing guidelines to consider the latest developments in vaccine manufacturing processes. These revised guidelines should account for efficient transfection using LNPs and cumulative dosing.
 
-Manufacturers of COVID-19 vaccines should provide transparent information about their vaccine composition and manufacturing processes, enabling researchers and regulatory agencies to assess safety more comprehensively.
 
-Further research should be conducted to replicate and expand upon the study's findings. A larger sample size and in-depth investigations are needed to confirm the dose-response relationship and explore potential mechanisms at work.
 
-Continued monitoring of adverse events in vaccine recipients is crucial to track any potential long-term effects related to DNA fragments in vaccines.
 
In the midst of an ongoing global health crisis, vaccine safety remains paramount. The discovery of DNA fragments in COVID-19 vaccines underscores the importance of rigorous oversight, transparent communication, and continual evaluation to ensure that vaccines continue to be a safe and effective tool in the fight against the pandemic.
 
The study findings were published on a preprint server and are currently being peer reviewed.
https://osf.io/mjc97/
 
For the latest COVID-19 News, keep on logging to Thailand Medical News.

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