DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.

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Paper Summary

Conflicts of Interest

Identified Weaknesses

Rating Explanation

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Paper Summary

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DNA Contamination in mRNA Vaccines: More Than We Bargained For?

This study found significant levels of DNA contamination in all 27 vials of Pfizer and Moderna mRNA COVID-19 vaccines tested. While below FDA guidelines when measured by qPCR, total DNA levels, measured by fluorometry, significantly exceeded recommended limits, potentially impacting safety. A preliminary analysis suggests a correlation between DNA levels and adverse events, warranting further investigation.

Possible Conflicts of Interest

One of the authors (K McKernan) is employed by Medicinal Genomics and provided the qPCR reagents free of charge. This potential conflict is disclosed in the paper.

Identified Weaknesses

Small sample size

27 vials from 12 lots is a relatively small sample size, limiting the generalizability of the findings. Larger, more comprehensive studies are necessary to confirm the results.

Correlation vs. Causation

The study found a correlation between DNA levels and reported adverse events in VAERS. However, correlation does not equal causation, and further research is needed to determine if residual DNA directly contributes to adverse events.

Reliance on VAERS data

VAERS is a self-reporting system and subject to underreporting and other biases. Relying solely on VAERS for assessing adverse events may not provide a complete picture.

Lack of mechanistic explanation

The study observes a potential link between DNA contamination and adverse events, but it does not explore the mechanism by which this could occur. Further research is needed to understand the potential biological impact of the DNA contamination.

Rating Explanation

The study presents important findings regarding DNA contamination in mRNA vaccines, but the small sample size, reliance on VAERS data, the correlational nature of the analysis, and the lack of mechanistic explanation warrant a cautious interpretation of the results and limit the overall rating to a 3.

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Topic Hierarchy

Domain:

Health Sciences

Field:

Medicine

Subfield:

Pharmacology

File Information

Original Title:

DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.

File Name:

paper_1209.pdf

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September 07, 2025 at 09:58 AM

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