Letter from the Editor


Jule Klotter

On September 11, 2023, the US Food and Drug Administration approved and authorized emergency use for updated mRNA covid vaccines made by Pfizer and Moderna that target Omicron variant XBB.1.5.1  FDA and CDC, which added the boosters to the childhood vaccine schedule, recommend them for anyone over age six months.1,2

The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.1

I’m finding it impossible to understand how these agencies can maintain the “safe and effective” mantra for these products, given the unusually high numbers of vax-related injuries and the latest information about the products’ contents.

When the mRNA vaccines that were supposed to end the pandemic were being tested, I found some early articles about the new mRNA technology. Although the technology had been around for years, it had never before been used as a preventive to protect humans from infectious disease. Unlike traditional vaccines that contain the antigen (virus or bacteria) to incite immunity, these injections contain mRNA that tells cells to create the antigen—in this case the spike protein.

So little was available then. Mostly, some scientists were asking questions about having our bodies produce the spike protein, the most problematic part of the SARS-Co-2 virus. As early as February 2021, researchers were suggesting that the spike protein was responsible for the abnormal inflammatory blood clotting found in some covid patients.3

Now, four years later, molecular biologists and other scientists have uncovered information we didn’t have then. And they also have many unanswered questions.

First, German microbiologist Klaus Steger, PhD, recently pointed out that these injections do not contain natural messenger RNA (mRNA).4 These products use modified (synthetic) RNA (modRNA)—as admitted on Pfizer’s website.5 Natural mRNA lives only for a short time and is cell-specific; it carries the instructions for making a specific protein to ribosomes, the protein-making factories in the cells.

In contrast, modRNA lasts longer in the body and produces more protein than the same amount of mRNA. Also, Steger explains, “… modRNA can invade nearly every cell type.” The vaccine-modRNA is encased in lipid nanoparticles that merge easily with a cell’s membrane, facilitating entry into cells. In addition, the lipid envelope protects the modRNA from destruction by the immune system. Unlike natural viral or bacterial pathogens, the lipid nanoparticles have no antigens that would attract an immune response.

Steger explains, “The vaccine and booster modRNA will continue to produce spike protein (for weeks or even months, which is entirely different from a natural infection), as our cell machinery (e.g., the enzyme RNase) cannot destroy the artificial modRNA.”4  In August 2023, a research team, led by Carlo Brogna, reported detecting synthetic spike protein in 50 percent of a group who had received modRNA vaccines 69 to 187 days before.6

In a September 2023 article, Panagis Polykretis and colleagues point out that the manufactured spike protein is displayed on the cell membranes of infected cells.7 Recognizing the protein as a foreign threat, the immune system launches a response that eventually kills the cell. Remember: the modRNA in its lipid envelope can enter “nearly any type of cell.” The researchers state:

Considering that every cell that synthesizes viral proteins is perceived as a threat by the immune system and killed, it becomes crucial to determine the exact biodistribution of the genetic vaccines within the organism.7

A rat study, performed in March 2022, indicated that the modRNA accumulated in the liver, adrenal glands, spleen, ovaries, and other tissues. Unlike traditional vaccines, these injections cause the immune system to turn against tissues that would not be affected by the natural virus; in effect, these injections promote an inflammatory autoimmune reaction.

In addition to possible adverse effects from the spike protein itself and its indiscriminate replication, researchers have voiced concerns about the pro-inflammatory effects of lipid nanoparticles. In a 2022 editorial, Seyed Moein Moghimi and Dmitri Simberg state:

The success of LPN-based [lipid nanoparticle-based] vaccines has prompted a surge in overenthusiastic research focused on the broader application of LNP-based nanomedicines. Considering the pro-inflammatory nature of the currently available ionizable cationic lipids, notably their undesirable immune cascade initiated through the IL-1β release, and of other cationic lipids, the potential application of LNPs for systemic administration must be viewed cautiously.8

DNA contamination is another issue. Early in 2023, Kevin McKernan, an expert in sequencing methods for DNA and RNA, reported finding unacceptably high levels of DNA contamination in the Pfizer and Moderna injections.9 The bits of DNA (plasmids that can replicate) included genes resistant to the antibiotic kanamycin. Also, sequences from the SV-40 virus (a virus that can promote tumors) were found in the Pfizer vaccine.10

Skeptical about McKernan’s findings, cancer genomics expert Phillip Buckhaults, who is a professor at the University of South Carolina, decided to test modRNA vials himself. Instead of debunking McKernan’s claim, he ended up confirming it. Buckhaults recently testified about his findings before the South Carolina Senate Medical Affairs Committee.11,12 He explained that low-level DNA contamination occurs in traditional vaccines, but tissue enzymes destroy these plasmids before they enter cells. With this new technology, however, the lipid nanoparticles protect the plasmids and facilitate their entry into cells—just as it protects the modRNA.

In a recent interview, Buckhaults told Maryanne Demasi that it is possible that a piece of DNA can travel to the nucleus and get into the genome:

I have a background in cancer genetics and cancer biology, somatic mutations are my expertise. And I think that there is a reasonable chance that if you inject pieces of DNA that are wrapped up in this transfection particle – the lipid nanoparticle—there is a reasonable chance that some of this is going to get into cells, and then integrate into the genome of cells. I think we should check and find out.13

Demasi contacted FDA about the contamination—as Dr. Buckhaults had earlier. Buckhaults received no response, and Demasi received a written statement that asserted, “The FDA is confident in the quality, safety, and effectiveness of these vaccines. The agency’s benefit-risk assessment and ongoing safety surveillance demonstrates that the benefits of their use outweigh their risks.” I can’t help but wonder what safety surveillance the agency is actually using that supports that statement.

FDA defines these new vaccines as pro-drug: “substances that, after administration, are converted in the body into pharmacologically active drugs.”14 Some argue that these injections are actually a form of gene therapy. Whether “pro-drug” or gene therapy, the reality is that these injections are not anything like traditional vaccines.

Helene Banoun, an independent French researcher, enumerates several studies that should be conducted on this new type of vaccine—and haven’t been—including product quality; pharmacokinetic studies; shedding studies and excretion; dissemination in the body; persistence, clearance, and mobilization in the body; effects on reproduction; embryo-fetal toxicity; and  mutagenic and carcinogenic potential.15 In the rush to address covid, these studies were not performed.

Now that the emergency is over (although FDA is still relying on emergency use authorization for the new boosters), these products need to be rigorously assessed for safety—especially because Moderna, Pfizer, and other companies plan to release other modRNA vaccines. Banoun writes. “…Moderna has many mRNA vaccines in clinical trials (COVID-19, influenza, human metapneumovirus, parainfluenzas, RSV, HCoV, CMV, EBV, HSV, varicella, herpes, HIV, Zika, Nipah), in particular a phase 3 trial of the flu vaccine.”15

So, when someone equates modRNA vaccines with the traditional vaccines that so many have relied upon to prevent illness, be aware that they are conflating zebras with horses. They are two totally different animals, and the true risks of these new products are unknown.

In this Issue

Sue Visser’s six-part series on food as medicine concludes with a look at food-based protocols that she has found beneficial for people with serious illnesses, including cancer, Parkinson’s, lupus, and heart disease. Visser, who lives in South Africa, is the health researcher and product developer for Nature Fresh Health Products. She has developed over 45 products, beginning with her unique Calcium Complex formulation in 1997.

Her articles in this series have discussed the inter-relationships of nutrients, deficiencies caused by pharmaceuticals, and the importance of choosing nutrient-rich foods. I know this series has encouraged me to focus on eating health-supporting foods—instead of relying on supplements to take up the slack.  I hope her articles have helped others as well.


References

  1. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating
  2. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html
  3. Arntsen E. COVID can affect the blood. Its spike protein may be the culprit. Northeastern Global News. February 8, 2021.
  4. Steger K. COVID-19 Vaccines and Boosters Were Never Made with mRNA. The Epoch Times.  July 27, 2023.
  5. What formats of mRNA does Pfizer use? https://www.pfizer.com/science/innovation/mrna-technology
  6. Brogna C, et al. Detection of recombinant Spike protein in the blood of individuals vaccinated against SARS-CoV-2: Possible molecular mechanisms. Proteomics Clinical Applications. August 31, 2023. https://onlinelibrary.wiley.com/doi/full/10.1002/prca.202300048
  7. Polykretis P, et al. Autoimmune inflammatory reactions triggered by the COVID-19 genetic vaccines in terminally differentiated tissues. Autoimmunity. September 14, 2023.
  8. Moghimi SM, Simberg D. Pro-inflammatory concerns with lipid nanoparticles. Molecular Therapy. June 2022; 30(6); 2109-2110.
  9. McKernan K. Deep sequencing of the Moderna and Pfizer bivalent vaccines identifies contamination of expression vectors designed for plasmid amplification in bacteria. February 15, 2023. https://anandamide.substack.com/p/curious-kittens
  10. Palmer M, Gilthorpe J. COVID-19 mRNA vaccines contain excessive quantities of bacterial DNA: evidence and implications. April 5, 2023. https://doctors4covidethics.org/wp-content/uploads/2023/04/dna-contamination5.pdf
  11. Senate Medical Affairs Committee. September 12, 2023. https://www.scstatehouse.gov/video/archives.php; testimony begins at 3:35.
  12. Demasi M. Researchers “alarmed” to find DNA contamination in Pfizer covid-19 vaccine. September 18, 2023. https://maryannedemasi.substack.com/p/researchers-alarmed-to-find-dna-contamination
  13. Demasi M. Exclusive: An interview with Buckhaults about DNA contamination in covid vaccines…and the FDA responds. September 21, 2023. https://maryannedemasi.substack.com/p/exclusive-an-interview-with-buckhaults
  14. Redshaw, M. mRNA Covid-19 Vaccines Should Be Labeled Gene Therapy Products: Peer-Reviewed Paper.  The Epoch Times. June 30, 2023
  15. Banoun H. mRNA:Vaccine or Gene Therapy? The Safety Regulatory Issues. International Journal of Molecular Sciences.  2023;24:10514.

Published October 7, 2023