Submit Your Comment To The FDA
The FDA has received a Citizen Petition informing them that independent researchers around the world have found unacceptable levels of DNA contamination in the Pfizer-BioNTech and Moderna "vaccines."
Katie Ashby-Koppens of PJ O’Brien & Associates submitted a Citizen Petition to the FDA on January 21, 2025 on behalf of Julian J. Gillespie, Kevin McKernan, David J. Speicher, Jessica Rose, and L. Maria Gutschi, requesting that the licenses and authorizations for the Pfizer-BionTech and Moderna mRNA products be REVOKED.
Download and read the entire petition:
https://www.regulations.gov/document/FDA-2025-P-0335-0001
Everyone on earth can submit a public comment to the FDA.
You do NOT need to be a citizen of the United States in order to submit a public comment.
EVERYONE ON EARTH may submit a text comment (up to 5,000 characters) and EVERYONE may also upload up to 20 files, each of which may be up to 10MB.
Click on the link below to submit YOUR public comment:
https://www.regulations.gov/commenton/FDA-2025-P-0335-0001
You may provide your name and email address when you submit your public comment, or you can choose to submit your public comment anonymously.
Most people choose “Individual Consumer” from the choices in the pulldown menu:
Click on the link below to read comments that have already been submitted and published.
https://www.regulations.gov/docket/FDA-2025-P-0335/comments
On the web page above, you WILL be able to read other people’s comments, but it will APPEAR that the comments have been closed. THAT IS NOT THE CASE. YOU CAN MAKE A COMMENT. Be sure to click on the link above the red arrow above. The Citizen Petition should be open for comments for 180 days.
Before you submit a public comment, please take the time to read the details of the three sections of the Citizen Petition (below) that focus on the issue of DNA contamination which, in and of itself, should be adequate grounds for the licenses and authorizations to be revoked.
CLICK HERE for additional details.
B. Synthetic DNA Contamination
6.0 Significant Evidence of DNA Contamination
6.1 Evidence from multiple independent studies confirms the presence of excessive levels of synthetic DNA contamination in the Pfizer and Moderna modRNA Covid-19 products.
The studies, reports and key findings are:
a. A December 2024 peer-reviewed study (14) supervised by FDA scientists detected synthetic DNA contamination levels between 6 and 470 times above the regulatory safety threshold of 10ng per dose, in both the Pfizer and Moderna Covid-19 products, including SV40 promoter and enhancer sequences. This study confirmed the synthetic DNA contamination is encapsulated and protected by the Lipid Nanoparticles (LNPs) used to encapsulate, protect, and efficiently transfect the modRNA into human cells; therefore the synthetic
DNA contamination is not “naked”, where the safety threshold of 10ng per dose only applies to “naked” and unprotected DNA able to be broken down quickly and efficiently by human blood.
b. South Australian researchers collected data (15) confirming synthetic plasmid DNA in the blood of 75 participants who received the Pfizer or Moderna Covid-19 products, including SV40 promoter and enhancer sequences.
c. A December 2024 peer-reviewed study (16) by German researchers detected synthetic DNA contamination levels between 3 to over 4 times above the regulatory safety threshold in the Pfizer Covid-19 products, including SV40 promoter and enhancer sequences.
This study confirmed the synthetic DNA contamination is encapsulated and protected by the Lipid Nanoparticles (LNPs) used to encapsulate, protect, and efficiently transfect the modRNA into human cells; therefore the synthetic DNA contamination is not “naked”, where the safety threshold of 10ng per dose only applies to “naked” and unprotected DNA able to be broken down quickly and efficiently by human blood.
This study confirmed the synthetic DNA is efficiently transfected into human cells, including transfection of SV40 promoter and enhancer sequences.
d. A November 2024 French study (17) detected excessive synthetic DNA contamination in the Pfizer Covid-19 drug.
This study confirmed the synthetic DNA contamination is encapsulated and protected by the Lipid Nanoparticles (LNPs) used to encapsulate, protect, and efficiently transfect the modRNA into human cells; therefore the synthetic DNA contamination is not “naked”, where the safety threshold of 10 ng per dose only applies to “naked” and unprotected DNA able to be broken down quickly and efficiently by human blood.
e. A September 2024 expert report (18) prepared for Australian legal proceedings confirms synthetic DNA contamination levels between 7 and 145 time above the regulatory safety threshold in both the Pfizer and Moderna Covid-19 products, including SV40 promoter and enhancer sequences.
This study confirmed the synthetic DNA contamination is encapsulated and protected by the Lipid Nanoparticles (LNPs) used to encapsulate, protect, and efficiently transfect the modRNA into human cells; therefore the synthetic DNA contamination is not “naked”, where the safety threshold of 10ng per dose only applies to “naked” and unprotected DNA able to be broken down quickly and efficiently by human blood.
f. A May 2024 peer-reviewed study (19) by German researchers detected synthetic DNA contamination levels between 360 and 534 times above the regulatory safety threshold in the Pfizer Covid-19 drug, including SV40 promoter and enhancer sequences.
This study confirmed the synthetic DNA contamination is encapsulated and protected by the Lipid Nanoparticles (LNPs) used to encapsulate, protect, and efficiently transfect the modRNA into human cells; therefore the synthetic DNA contamination is not “naked”, where the safety threshold of 10ng per dose only applies to “naked” and unprotected DNA able to be broken down quickly and efficiently by human blood.
g. April 2024 preliminary findings (20) by US Professor of Molecular Biology & Genetics confirms synthetic DNA contamination in the Pfizer Covid-19 drug above the regulatory safety threshold.
h. An October 2023 study (21) by Speicher et al detected synthetic DNA contamination levels between 188 and 509 times above the regulatory safety threshold of 10 ng per dose, in both the Pfizer and Moderna Covid-19 products, including SV40 promoter and enhancer sequences.
i. A September 2023 study (22) by McKernan et al detected synthetic DNA contamination levels between 18 and 70 times above the regulatory safety threshold in both the Pfizer and Moderna Covid-19 products, including SV40 promoter and enhancer sequences.
j. Putative findings (23) have confirmed this synthetic DNA can and does integrate into human genomic DNA and can replicate within human cells. McKernan has further reported (24) early-stage evidence of self-replication of the synthetic DNA within human cancer tumours, demonstrating a capacity for independent propagation.
7.0 Legal and Regulatory Failures
7.1 There are numerous legal and regulatory failures for which EUA does not explain nor excuse, namely:
a. 42 U.S.C. § 262(a)(2)(C)(i) (25) requires applicants for a BLA to submit data to demonstrate that the biological product is safe, pure, and potent. The data to be provided by sponsors encompasses detailed information about the manufacturing process, which includes genetic materials like plasmid DNA used in production.
b. 21 CFR 601.2 (26) requires sponsors to provide a complete description of the manufacturing process, including detailed information about the genetic material used. Detailed plasmid DNA maps showing Open Reading Frames (ORFs), promoters, enhancers, and other genetic elements must be disclosed to ensure the integrity of the final product.
At no time when seeking BLA approval from the FDA did Pfizer provide a plasmid DNA map detailing the SV40 promoter and enhancer sequences forming part of the plasmid DNA used to manufacture its Covid-19 products, nor did Pfizer otherwise disclose that its plasmid DNA used in the manufacture of its Covid-19 products, included and includes the SV40 promoter and enhancer sequences.
c. FDA guidance (27) requires sponsors submit detailed plasmid DNA maps and descriptions of all sequences used in production, including Open Reading Frames (ORFs), promoters, and enhancers (e.g., SV40), to assess risks of unintended expression or other effects.
At no time when seeking BLA approval from the FDA did Pfizer provide a plasmid DNA map detailing the SV40 promoter and enhancer sequences forming part of the plasmid DNA used to manufacture its Covid-19 products, nor did Pfizer otherwise disclose that its plasmid DNA used in the manufacture of its Covid-19 products, included and includes the SV40 promoter and enhancer sequences.
d. At no time prior to or after the approvals of the BLAs for the Pfizer and Moderna Covid-19 products did the FDA consider the regulatory threshold of 10ng per dose for “naked” synthetic DNA to have no meaning in the context of the Covid-19 products of Pfizer and Moderna which use LNPs capable of, and which in fact do encapsulate and protect residual DNA templates (synthetic DNA) so as to not be “naked”, where the LNPs are capable of, and in fact do efficiently transfect (transfer) the synthetic DNA inside human cells, which transfection process “naked” DNA is unable to do without the aid of LNPs.
Consequently, the regulatory threshold of 10ng per dose for “naked” DNA is entirely meaningless for the Covid-19 products of Pfizer and Moderna, where the safety threshold should have been (prior to any BLA approvals) and must be, revised significantly lower by the FDA.
At no time when seeking BLA approval from the FDA did Pfizer disclose that its plasmid DNA used in the manufacture of its Covid-19 products, included and includes the SV40 promoter and enhancer sequences.
8.0 Health Risks posed by Synthetic DNA Contamination (28)
8.1 The following are just a number of the health risks posed by Synthetic DNA Contamination; there may be many more that have not yet been discovered:
a. High Transfection Efficiency: Encapsulation of synthetic DNA within lipid nanoparticles (LNPs) ensures efficient delivery to human cells. Unlike naked DNA, LNP-protected synthetic DNA bypasses immune detection, crosses cell membranes, and integrates into cells, including their nuclei.
b. Systemic Distribution and Efficient Transfection by LNPs: Recent research (29) has demonstrated the systemic distribution of lipid nanoparticles (LNPs) following injection, confirming their delivery of genetic material to cells across all major organs, including the brain, lungs, heart, liver, spleen, testes, and ovaries. This efficient transfection likely extends to the synthetic DNA contaminants encapsulated within these LNPs, as confirmed by earlier disclosures (30) made by Pfizer to Japanese regulatory authorities. The broad bio- distribution of these particles significantly amplifies the potential for synthetic DNA to integrate into diverse cellular environments throughout the human body.
c. Integration into Genomic DNA: Synthetic DNA can integrate into human chromosomal DNA during cell division or with the assistance of Simian Virus 40 (SV40) nuclear localisation sequences, present in the Pfizer vaccine. Such integration poses risks of genomic instability and insertional mutagenesis, which can trigger cancers, especially leukemia.
d. Minimal Threshold for Cancer Risk: Studies show that the insertion of as few as 3 - 10 SV40-enhanced synthetic DNA molecules into a single cell can provoke a malignant response. This contrasts starkly with the billions of SV40 molecules delivered in a contaminated dose, significantly amplifying cancer risks.
e. Magnitude of Contamination: Independent analyses have detected synthetic DNA levels in Pfizer and Moderna products exceeding regulatory thresholds by 6 to 534 times. Each contaminated dose contains approximately 60 billion to 575 billion SV40 molecules.
f. Impact on Tumour Suppressors: SV40 sequences in synthetic DNA bind to tumour suppressor protein p53, which is crucial for genome protection. This binding neutralizes p53's cancer-preventing role, enhancing the risk of tumour proliferation.
g. SV40 Enhancers and Somatic Hypermutability: The SV40 enhancer sequences found in synthetic DNA contaminants are now recognized (31) as somatic hypermutability elements. These sequence elements have been shown to actively promote genetic instability and enhance risks associated with oncogenesis. This evidence directly contradicts earlier claims (32) by regulatory agencies that these sequences were non-functional and underscores their role in elevating cancer risks through mutagenic activity.
h. Heritable Genetic Changes: Synthetic DNA can transfect germline cells, such as oocytes and sperm-producing cells, potentially creating transgenic offspring or causing early developmental disruptions, miscarriages, and malformations.
i. Cytosolic Transfection and Oncogenesis: Emerging evidence (33) highlights that cytosolic transfection of DNA alone - without genomic integration - can induce oncogenesis by triggering a robust interferon response. This immune reaction is a known precursor to inflammatory diseases and cancer. The presence of synthetic DNA contaminants encapsulated in LNPs exacerbates this risk, as their high transfection efficiency ensures widespread cytosolic presence, elevating the potential for oncogenic transformations even without direct genomic integration.
j. Potential for Self-Replication: SV40 genetic elements enable the synthetic DNA to replicate autonomously within human cells, compounding the risk of genomic integration and amplifying the chances of malignant transformations.
k. Other Severe Risks: Additional contaminants identified in these products, including synthetic RNA:DNA hybrids and double-stranded synthetic RNA, have been linked to severe diseases such as blood clots and immune disorders.
REFERENCES:
(14)
https://anandamide.substack.com/p/fda-white-oak-lab-finds-6x-to-470x
https://blog.maryannedemasi.com/p/exclusive-fda-lab-uncovers-excess
(15)
https://osf.io/preprints/osf/hzyn3_v1
https://anandamide.substack.com/p/chakraborty-open-review
https://anandamide.substack.com/p/chakraborty-part-ii-odak-et-al
https://blog.maryannedemasi.com/p/part-1-blood-samples-contain-dna
(16)
https://anandamide.substack.com/p/the-most-comprehesive-study-on-vax
(17)
https://hal.science/hal-04778576v1
https://anandamide.substack.com/p/more-papers-on-dna-contamination
(18)
https://classic.austlii.edu.au/au/legis/cth/consol_act/gta2000162/
https://news.rebekahbarnett.com.au/p/breaking-dna-contamination-in-australian
https://julesonthebeach.substack.com/p/synthetic-dna-contamination-the-final
(19)
https://www.mdpi.com/2409-9279/7/3/41
(20)
https://x.com/P_J_Buckhaults/status/1782551861083685223
(21)
https://osf.io/preprints/osf/mjc97_v1
(22)
https://osf.io/preprints/osf/b9t7m_v1
(23)
https://x.com/P_J_Buckhaults/status/1861083163868672204
https://anandamide.substack.com/p/sv40-origin-of-replication-in-mammalian
(24)
Ibid.
(25)
https://www.law.cornell.edu/uscode/text/42/262
(26)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601/subpart-A/section-601.2
(27)
https://www.fda.gov/media/113760/download
https://www.fda.gov/media/77528/download
(28)
https://russellbroadbent.com.au/australiansdemandanswers/
(29)
https://www.nature.com/articles/s41587-024-02528-1
(30)
https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf?utm_source=chatgpt.com
(31)
https://pubmed.ncbi.nlm.nih.gov/39490533/
https://pmc.ncbi.nlm.nih.gov/articles/PMC11564006/pdf/main.pdf
(32)
(33)
https://pubmed.ncbi.nlm.nih.gov/31852718/
James Roguski
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I have been licensed since 1983, doing integrated medicine and prevention. From what I have seen in medical practice, all vaccines should be stopped and the effects studied. I quit giving vaccines in 1986! If parents wanted vaccines for their children or adulst wanted them, I sent them to the health department. I believe the MRNA shots are contaminated and the additives are extremely toxic.
I will of course, be signing this. However, I truly believe the most impact will come from handing out 'business cards'. Just as I did with pamphlets about the uselessness/ dangers of mask wearing, I intend to strategically place them at doctors' offices, the grocery store, etc, and hand them directly to people. I firmly believe that the only way this ends, is with us. Politicians, law enforcement, government agencies and hospitals are obviously not interested. I can't say thank you enough, James. Your work is stellar.