"Neurological symptoms and cognitive decline with accelerated neurodegenerative disease are features of acute COVID-19 vaccine injuries. ...Two components in the mRNA lipid nanoparticle complexes, ALC-0315 and ALC-0159, are concerning..."
Authored by Megan Redshaw: The U.S. government and pharmaceutical companies are investing a substantial amount to develop new mRNA vaccines for infectious diseases and cancer, fueling a lucrative mRNA platform valued at $136.2 billion.
Pharmaceutical companies such as Moderna, BioNTech, and CureVac are conducting clinical trials using mRNA-based vaccines with advanced melanoma, ovarian, colorectal, and pancreatic cancers. The National Institutes of Health is partnering with BioNTech to develop a personalized vaccine for pancreatic cancers. In addition to COVID-19 and cancer, other mRNA-based vaccines in development target influenza, genital herpes, respiratory viruses, and shingles.
Although mRNA platforms are appealing because they reduce costs and shorten the vaccine development timeline, evidence and experience suggest the mRNA technology used for novel COVID-19 vaccines is associated with various harms and neither prevents COVID-19 nor its transmission.
Evidence Challenging Vaccine ‘Safe and Effective’ Narrative
The unprecedented rates of adverse events following COVID-19 vaccination overshadow the benefits, according to researchers from Australia who say the SARS-CoV-2 spike protein, whether from the virus or created from genetic code in mRNA and adenovectorDNA vaccines, is toxic and causes a wide array of diseases.
In their recently published paper published in Biomedicines titled, “‘Spikeopathy’: COVID-19 Spike Protein Is Pathogenic, from Both Virus and Vaccine mRNA,” the researchers explored peer-reviewed data countering the “safe and effective” narrative attached to new technologies used to develop mRNA and adenovectorDNA vaccines at “warp speed” to end the pandemic.
Spike protein pathogenicity, termed “spikeopathy,” describes the ability of the spike protein to cause disease, and the researchers say it can affect many organ systems.
Researchers noted the following key problem areas:
- Spike protein toxicity (spikeopathy) from both the virus and when produced by gene codes in people vaccinated with COVID-19 vaccines.
- Inflammatory properties in specific lipid nanoparticles (LNPs) used to transport mRNA.
- Long-lasting action caused by N1-methyl pseudouridine in the synthetic mRNA—also referred to as modRNA.
- Widespread distribution of mRNA and DNA codes via the LNP and viral vector carrier matrices, respectively.
- Human cells produce a foreign protein that can cause autoimmunity.
Now that vaccines utilizing mRNA technology have been available and widely distributed for several years, data show these vaccines produce foreign antigens in human tissues and increase the risk of autoimmune, neurological, cardiovascular, inflammatory disorders, and cancers, especially when the vaccine ingredients do not remain localized at the injection site. An antigen is any substance that stimulates an immune response. If the immune system encounters an antigen that is not found on the body’s own cells, it will launch an attack against that antigen.
Pharmacokinetic and pharmacodynamic data show the design of the mRNA and adenovectorDNA COVID-19 vaccines allow uncontrolled biodistribution, durability, and persistent bioavailability of the spike protein inside the body after vaccination. Pharmacokinetics is the study of how the body interacts with administered substances for the entire duration of exposure. Pharmacodynamics assesses the drug’s effect on the body more closely.
This may explain the unprecedented number of adverse events that appear to be associated with the spike protein produced by the gene-based technologies employed by Pfizer, Moderna, AstraZeneca, and Johnson & Johnson, as well as the viral vector DNA technology used by other countries, researchers said.
mRNA Vaccines Are Gene Therapy and May Cause Harm
Gene-based COVID-19 vaccines are therapeutic products that actually fit within the FDA’s definition of gene therapy because they cause the cells of the vaccinated person to produce antigens for transmembrane expression that invokes an immune response. By design, these novel vaccine platforms risk tissue damage secondary to autoimmune responses raised against cells expressing foreign spike antigens, researchers said.
The FDA was aware of the pathogenicity of spike proteins before releasing COVID-19 vaccines to the public. In an October 2022 meeting with its vaccine advisors, the FDA presented a highly accurate list of potential adverse events associated with COVID-19 vaccines, including neurological, cardiovascular, and autoimmune “possible adverse events.”
React19, an organization that provides financial, emotional, and physical support to those experiencing long-term injuries from COVID-19 vaccines, provided a list of over 3,400 published papers and case reports of injuries affecting more than 20 organ systems. More than 432 peer-reviewed papers relate to papers and case reports of myocarditis, cardiomyopathy, myocardial infarction, hypertension, aortic dissection, postural orthostatic tachycardia syndrome (POTS), tachycardia, and conduction disturbance—a problem with the electrical system that controls the heart’s rate and rhythm.
The most common group of adverse events reported following COVID-19 vaccination to both pharmacovigilance databases and Pfizer involve neurological disorders. According to the paper, neurological symptoms and cognitive decline with accelerated neurodegenerative disease are features of acute COVID-19 vaccine injuries and, to some extent, long COVID syndrome. Research suggests (pdf) LNPs transporting the mRNA to make spike proteins can cross the blood-brain barrier and cause neurotoxic effects.
Lipid Nanoparticles Are Toxic and Pro-Inflammatory
It’s not just the spike protein that can cause disease. LNPs that serve as the delivery method are also toxic and pro-inflammatory.
Research from 2018 showed even small amounts of nanoparticles taken up by the lungs can lead to cytotoxic effects. Ingested nanoparticles have been shown to affect lymph nodes, the liver, and the spleen, while when injected as a drug carrier, they can pass any barrier and translocate to the brain, ovaries, and testes, mainly after phagocytosis by macrophages, which help distribute them across the body. The effects on the reproductive system suggest lipid nanoparticles can be cytotoxic and damage DNA.
According to the authors, two components in the mRNA lipid nanoparticle complexes, ALC-0315 and ALC-0159, are concerning, as they have never been used in a medicinal product and are not registered in either the European Pharmacopoeia or in the European C&L Inventory database. A question posed to the European Parliament in December 2021 pointed out that the manufacturer of the nanoparticles specifies the nanoparticles are for research only and not for human use. The European Commission responded that the excipient in Pfizer’s Comirnaty vaccine “has been demonstrated to be appropriate … in compliance with the relevant EMA scientific guidelines and standards.”
Still, this could explain the root cause of numerous post-vaccination adverse events, researchers said.
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