THIS IS ONE PETITION THAT NEEDS YOUR ATTENTION - Demand Action on DNA Contamination in Pfizer-BioNTech and Moderna Vaccines - Submit Your Comments to the FDA

On January 21, 2025, a Citizen Petition was submitted to the U.S. Food and Drug Administration (FDA), calling for the revocation of the licenses and authorisations for the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines.

The petition, submitted by Katie Ashby-Koppens of PJ O’Brien & Associates, represents a coalition of independent researchers and scientists including Julian J. Gillespie, Kevin McKernan, David J. Speicher, Jessica Rose, and L. Maria Gutschi. The core issue raised in the petition: unacceptable levels of DNA contamination in both the Pfizer and Moderna COVID-19 vaccines.

This alarming issue has garnered attention from multiple independent researchers around the world, who have found that these vaccines contain synthetic DNA that exceeds the regulatory safety threshold - those researchers include Kevin McKernan who managed R&D of the Human Genome Project and Dr. David Speicher a senior associate researcher and Virologist, as well as out of the FDA’s own laboratory.

This contamination poses very serious health and include:

• Genomic Instability
  Synthetic DNA can integrate into human DNA (particularly since the lipid nanoparticles (LNPs) assist in transfection into cells and nuclei, leading to potential disruption and mutations in our genetic material.

• Cancer
  Tumor formation and cancers are especially concerning, including but not limited to blood and bone cancers such as leukemias.

• Immune System Disruption
  Impaired immune responses, weakening the body's ability to defend against infections and increasing the risk of autoimmune diseases.

• Hereditary Effects
  Alteration of germline cells (e.g., sperm or eggs), potentially passing genetic changes or mutations to offspring, causing miscarriages, birth defects and hereditary diseases.

If you are concerned about these issues, you have the opportunity to make a difference. There is an open call for participation, and everyone—regardless of nationality—is encouraged to submit a comment. Your input could play a crucial role in shaping the future of vaccines and the broader medical system.

How You Can Submit Your Public Comment to the FDA

You do not need to be a U.S. citizen to submit a comment. Here’s how you can take action:

1. Submit Your Comment:
   Click HERE to submit your comment to the FDA.

   • You can write a text comment (up to 5,000 characters) or upload up to 20 files (max 10MB per file).

   • You may submit your comment anonymously, or you can choose to include your name and email address.

   

   • You may use any or all of the points discussed in this article as a guide or use your own words.

2. Read Others’ Comments:
   You can also view the comments already submitted by others by clicking HERE. Don’t be discouraged if the page appears closed—it is still open for your comment. The comment period for the Citizen Petition will remain open for 180 days.

3. Key Focus: DNA Contamination in mRNA Vaccines
   The Citizen Petition centers on synthetic DNA contamination found in both the Pfizer-BioNTech and Moderna vaccines. Independent research has shown that the levels of DNA contamination far exceed the FDA's established safety threshold of 10ng per dose. This contamination includes SV40 promoter and enhancer sequences, which are known to have dangerous implications for human health, including potential cancer risks.

   Video: 1 min 51 sec - Plasmid DNA Contamination in COVID Vax Up to 500 TIMES What is Acceptable

Video: 3min 30 sec - Kevin McKernan: EMA Docs Reveal 1-815x DNA Contamination Variance in Vaccines

The Alarming Evidence of DNA Contamination

The petition outlines the evidence provided by multiple peer-reviewed studies and independent expert reports, which confirm the presence of synthetic DNA in the vaccines. Here are some key findings:

1. Peer-Reviewed Studies on DNA Contamination

   • A December 2024 study, led by FDA scientists, found DNA contamination levels 6 to 470 times above the regulatory safety threshold in both Pfizer and Moderna vaccines. This DNA is encapsulated within lipid nanoparticles (LNPs), which protect it from being broken down by the immune system and efficiently deliver it into human cells.

   • Additional studies from South Australia, Germany, France, and other research institutions have detected significant levels of DNA contamination, some up to 534 times higher than regulatory limits. This includes the dangerous SV40 promoter and enhancer sequences, which are linked to cancer risk.

2. Health Risks of Synthetic DNA Contamination

   • Genomic Integration and Cancer Risks: The presence of synthetic DNA, and SV40 sequences, in the vaccines could lead to genomic instability and the integration of this DNA into human cells. This poses a risk for cancer development, including leukemia, by disrupting tumor suppressor proteins like p53.

   • Efficient Delivery by LNPs: Unlike "naked" DNA, which is quickly degraded by the body, the LNPs used in mRNA vaccines protect the synthetic DNA, allowing it to efficiently enter human cells. This means that the DNA can integrate into the human genome or replicate within cells, potentially leading to harmful genetic changes and/or tumour formation.

   • Somatic Hypermutation: The SV40 sequences are known to act as somatic hypermutation elements, which can increase genetic instability, further elevating the risk of oncogenesis (cancer formation).

   • Heritable Genetic Changes: There is concern that the synthetic DNA could affect germline cells (sperm and egg cells), potentially passing on genetic changes, miscarriages, and birth defects to future generations.

3. Regulatory and Legal Failures
   The Citizen Petition also highlights significant regulatory failures in the approval process for these vaccines. The FDA did not require full disclosure of the plasmid DNA used in vaccine manufacturing, nor did it assess the risks posed by the synthetic DNA contamination. This failure to adequately address the risks of contamination undermines public trust in the regulatory process and raises serious questions about the oversight of vaccine safety.

Why This Matters: The Health Risks at Stake

The DNA contamination in the Pfizer and Moderna vaccines is not just a regulatory issue—it represents a serious health risk to those who have received the vaccines, as well as to future generations. It is a legal and moral issue. Synthetic DNA can integrate into the human genome, potentially leading to genomic instability, oncogenesis (cancer development), and other long-term health issues that have not been fully studied or disclosed.

Take Action: Submit Your Comment to the FDA Today

You have a right to voice your concerns. The FDA is required by law to review all public comments submitted during this period. By submitting a comment, you are helping to raise awareness and demand action on this issue.

This is a crucial moment in the history of vaccine safety, and your participation can make a difference. Click HERE to submit your public comment today.

Remember, you do not need to be a U.S. citizen to submit a comment. Everyone’s voice matters in this global conversation about vaccine safety.

For further details, you can download and read the full Citizen Petition HERE.

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Related Resources

• Excessive DNA contamination of mRNA Vaccines: Australian’s Demand Answers

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• James Rogusky - Submit your Comment to the FDA

• Maryanne Demassi - FDA Lab uncovers excess DNA Contamination

• Maryanne Demassi - PART 1: Blood samples contain DNA sequences from COVID-19 mRNA vaccine