Another Cause of Adverse Events

The Built-In Adjuvant Properties of mRNA and Lipid-Nanoparticles

Another thing that makes mRNA vaccines different and deadlier is their unique adjuvanticity. Vaccine manufacturers don’t have to add an adjuvant like MF59 or AS03 to the mRNA jabs to get an immune reaction, because the mRNA and the lipid nanoparticles (LNPs) that encase them are adjuvants on their own, meaning that they cause cell death and inflammation. This makes the mRNA vaccines even more dangerous than vaccines adjuvanted with toxins like MF59 and AS03.

In the 2023 paper “Knife’s edge: Balancing immunogenicity and reactogenicity in mRNA vaccines,” a team of scientists at the Institut Pasteur Korea, Catholic University of Korea, and Emory University describe the “built-in adjuvant properties of mRNA and LNPs” and explain that what makes the mRNA and lipid nanoparticles effective adjuvants is also what make them toxic. As these scientists put it, they "elicit pathological immune responses or side effects.” These are the side effects of the mRNA vaccines that they list:

How toxic is the mRNA?

The “Knife’s Edge” scientists explain that exogenous (foreign) RNA is inherently immunogenic. This increases the vaccine’s adjuvant effects, but it also makes the vaccine inherently dangerous. Among the harms listed by the authors that exogenous RNA can do to the body are “endothelial damage, intercellular junction relaxation, edema, increased viscosity, hypercoagulation, and thromboembolic events.” As the “Knife’s Edge” authors explain, this problem was well-known to the mRNA vaccine makers who solved it by chemically modifying the mRNA molecules. The authors cite the papers by Katalin Karikó and Drew Weissman, who won the 2023 Nobel Prize for this discovery that made mRNA vaccines possible.

The “Knife’s Edge” authors critique the Nobel Prize-winning work-around, writing that, “Theoretically, chemically modified unnatural molecules can improve the properties of natural mRNAs. However, intensive investigation of their safety is needed before therapeutic inclusion because the administration of unnaturally modified nucleoside molecules into human individuals has previously caused mitochondrial toxicity, liver failure, and even death during clinical trials. Therefore, the use of base modifications naturally found in RNAs might be a safer strategy for therapeutic applications.”

The problem that Karikó and Weissman “solved” is that it’s difficult to get your body to produce a given protein by injecting mRNA. Not only is it rapidly destroyed, but for the injection to work, they also need higher levels of protein expression than is naturally possible.

They bypassed this problem by making substitutions in the genetic instructions. They genetically manipulated the mRNA in a process called "codon optimization," where pseudouridine is inserted to stabilize the RNA and prevent rapid breakdown.

You can swap out certain nucleotides (three nucleotides make up a codon) and still end up with the same protein in the end, but the increased efficiency comes at a terrible cost.

When substituting parts of the code in this way, the resulting protein can easily get misfolded, and this has been linked to a variety of chronic diseases, including Alzheimer’s, Parkinson’s disease, and heart failure.

The pseudouridine insertion can also suppress your innate immune surveillance by dampening the activity of toll-like receptors, and one downstream effect of that is reduced cancer surveillance—one reason for the rise of “turbo cancers” amongst people who took the jabs.

How toxic are the mRNA COVID vaccines’ lipid nanoparticles?

The “Knife’s Edge” scientists say that, in one respect, the mRNA COVID vaccines’ lipid nanoparticles are a lot less toxic than they could be. The vaccine makers did the right thing using ionizable cationic lipids rather than the regular cationic lipids that were used to facilitate mRNA encapsulation in the earliest liposomal delivery systems. One example they give of the earlier, more dangerous mRNA encapsulations is Robert Malone's DOTMA. “Based on safety concerns,” they explain, those first cationic lipids “have not been considered suitable materials for developing current mRNA vaccines.” According to the authors, ionizable cationic lipids provide “maximal efficacy with limited toxicity.” We disagree on the “limited toxicity” point.

All cationic lipids, including the ionizable ones, are positively charged. The phospholipids in your cell membranes are negatively charged. That means cationic lipids are going to disturb the plasma membrane and cause an immune response. That’s the reason they were used—as an adjuvant, an initiator of cell death—to initiate an immune response. Ionizable cationic lipids serve that function spectacularly well.

Being extremely toxic to the cell membranes, the positively charged lipids trigger immune cells to rush in to aid the cells and mop up the spike protein now being produced, while also being the vehicle that allows the mRNA to slip into the cells.

Three ionizable cationic lipids, ALC-0315, SM-102, and DLin-MC3-DMA (MC3), are approved for clinical use. For the COVID-19 vaccines, Moderna used SM-102, and Pfizer/BioNTech employed ALC-0315 licensed from Acuitas.

Even though “these lipids are remarkably similar in structure,” they aren’t all equally safe. A full review of comparative safety has yet to be completed, but the authors mention that compared with MC3, ALC-0135 had “markedly lower toxicities.”

One problem with all three, ALC-0315, SM-102, and MC3, according to the “Knife’s Edge” authors, is that they all contain PEG, polyethylene glycol. Because of the dangers of PEG, which include anaphylactic shock and death, they write, “developing PEG-free delivery systems is necessary for future mRNA vaccine development.”

PEG hadn’t been used in vaccines before the mRNA COVID shots, so when reports of allergic reactions were made to health authorities as soon as the U.K. became the first to approve the mRNA shots in December 2020, it was obvious to scientists and regulators that PEG was the culprit.

Robert F. Kennedy Jr., chairman and chief legal counsel for Children’s Health Defense (CHD), had already notified Steven Hahn, President Donald Trump’s director of the U.S. Food and Drug Administration (FDA), Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, and Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, of the serious and possibly life-threatening anaphylactic potential of PEG—three months earlier. He wrote:

I’m writing to you today regarding Moderna’s mRNA vaccine in development that contains polyethylene glycol (PEG). The use of PEG in drugs and vaccines is increasingly controversial due to the well-documented incidence of adverse PEG-related immune reactions, including life-threatening anaphylaxis. Roughly seven in ten Americans may already be sensitized to PEG, which may result in reduced efficacy of the vaccine and an increase in adverse side effects. It is critical that FDA’s regulatory scrutiny of Moderna be beyond reproach, since other manufacturers will look to Moderna as a role model for their own safety studies. FDA’s review of Moderna’s vaccine should be a template for rigorous protocols that unambiguously elevate safety above political or monetary considerations. I urge that you give priority to your agency’s duty to protect public health and the rights of trial participants to genuine informed consent regarding the use of PEG. We ask you to order Moderna to immediately inform all trial participants of the risk for allergic reactions from PEG, and to carefully monitor and publicly disclose allergic reactions potentially associated with PEG.

These regulators knew that they were putting the 70 percent of Americans with PEG antibodies at risk of vaccine injury—and they didn’t do anything about it. COVID tests and vaccines were free and distributed to everyone. PEG antibody testing wasn’t even mentioned.

In the 2022 paper “Understanding the Role and Impact of Poly (Ethylene Glycol) (PEG) on Nanoparticle Formulation: Implications for COVID-19 Vaccines,” a team of scientists from Ireland, Italy, Sweden, and the U.K. unpacked the various ways PEG damages the body:

As PEG is metabolized, it damages the kidneys “in a manner similar to the renal failure associated with ethylene glycol poisoning.”

PEG could potentially affect the binding affinity of ligands to their receptors, which could implicate it in any number of diseases.

PEG isn’t your garden variety allergen. It can cause anaphylactic reactions that require a prior exposure (sensitization) to an allergen (antigen). But it can also trigger this type of hypersensitivity reaction in healthy people who haven’t been treated with PEGylated drugs before. This type of hypersensitivity reaction is known as complement activation-related pseudoallergy (CARPA). The symptoms are very similar to a normal hypersensitivity reaction, but they occur in a first contact without prior exposure and lack a specific allergen, which is why it is called a “pseudoallergy.” Both anaphylaxis and pseudoanaphylaxis present identical symptoms including breathing difficulties, urticaria, reduced blood pressure, and loss of consciousness, and the clinical management of these patients is also similar in the acute phase. However, in anaphylaxis, recovery is usually rapid (within 24 hours). With CARPA, the initial onset tends to be slower, and treatment may be required over four weeks to ensure complete recovery. CARPA can trigger the “immune stimulatory vicious cycle” where anti-PEG antibodies form in the wake of CARPA, causing pseudoallergy to become allergy.

Before the mRNA shots, according to the FDA, there were already 2.2 million adverse drug reactions each year in the U.S., with 106,000 fatalities, making it the fourth leading cause of death. By one estimate, 210,000 of these were CARPA. One of the PEGylated drugs known to cause CARPA is Thomas Haines’s Doxil, the first approved drug delivered via lipid nanoparticle. Doxil’s label reads: “WARNING: Acute infusion-related reactions, sometimes reversible upon terminating or slowing infusion, occurred in up to 10% of patients. Serious and sometimes fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications/emergency equipment to treat such reactions should be available for immediate use. ...” Others include Gilead’s Ambisome and DaunoXome and Novartis’s Visudyne, as well as monoclonal antibodies by Genentech (Avastin, Herceptin, Rituxan, and Xolair), Pfizer (Mylotarg), and Janssen (Remicade).

In 2024, a study comparing the mRNA vaccines to Doxebo (placebo Doxil) confirmed that the mRNA vaccines’ PEGylated lipid nanoparticles were responsible for adverse events involving inflammation, including the well-known mRNA vaccine side-effects— “myocarditis/pericarditis, anaphylaxis, autoimmune diseases, coagulation disorders, skin and ocular inflammations, Guillain-Barré syndrome and other neurologic problems." Follow-up studies by the same scientists addressed specific categories of PEGylated mRNA vaccine side effects such as “Comirnaty-induced cardiopulmonary distress.”