A newly established White House program announced on Aug. 23 that it is granting a total of $25 million over three years to Emory University, Yale School of Medicine, and the University of Georgia to develop personalized therapeutic vaccines against cancers and emerging infections, similar to how COVID-19 mRNA vaccines target SARS-CoV-2. They aim to use mRNA—an essential element in COVID-19 vaccines developed to prevent SARS-CoV-2 infections—to program a unique class of immune cells called dendritic cells to initiate a desired immunological response.
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.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.
- 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.
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.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.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.
“Even if it were non-toxic in its own right, by virtue of its foreignness, spike protein could still produce pathophysiological damage through autoimmune responses. A straightforward consequence of a foreign protein,” the researchers stated. “The lipid-nanoparticle matrix permits widespread biodistribution of mRNA gene codes to cells in most or all organs. The subsequent expression of the spike protein on cell surfaces, and as a soluble protein within the organs and bloodstream, induces T-cell destruction of cells and tissues and B-cell antibodies. The latter may also cause immune complex deposition, further damaging tissues ... ”
In addition to their potential toxicity, LNPs in COVID-19 vaccines have been found to “induce significant inflammatory cytokine secretion and macrophage inflammatory proteins with cell death.” Research has shown this pro-inflammatory effect can increase vaccine adjuvant immunogenicity of COVID-19 mRNA vaccines and contribute to adverse events. Researchers also stated that widespread biodistribution of the LNPs was not considered, nor was the potential for wide-ranging serious adverse events across multiple organs and systems.
Lipid Nanoparticles Widely Distribute mRNA Throughout the Body
According to the paper, LNPs in COVID-19 vaccines containing potentially inflammatory synthetic mRNA do not remain at the injection site after vaccination but are widely distributed throughout the body and can cross protective membranes.A European Medicines Agency report found, “mRNA could be detected in the brain following intramuscular administration at about 2 percent of the level found in plasma.” Another paper described how lipid nanoparticles can easily cross the blood-brain barrier.
Byram Bridle, Canadian virologist and vaccinologist, obtained a Pfizer biodistribution study in rodents from Japan that showed lipid nanoparticles could pass easily through biological tissues and membranes and travel to all organs. By 48 hours after vaccination, 75 percent of lipid nanoparticles had left the injection site with the highest concentrations in the spleen and liver. Levels were also detected in the ovaries, adrenal glands, brain, eyes, heart, testes, uterus, pituitary gland, spinal cord, thymus, and bone marrow. Further studies have since confirmed the results of Pfizer’s rat distribution study, researchers said.
Although some research suggests detection of the spike protein is restricted after the second dose due to anti-spike antibodies, since modified RNA molecules are highly stable, researchers say the spike protein production will persist until the immune system attacks or kills the cell.
Booster Shots Increase Potential for Adverse Events From Spike Protein
Both mRNA and adenovector DNA vaccines cause human cells to create a slightly modified version of the original Wuhan strain spike protein. In contrast, the bivalent booster doses add genetic code for the omicron variant spike protein.According to the researchers, if an individual experiences wide biodistribution of this genetic code, the body could produce many more spike proteins than what would occur with the natural virus. This is more likely the case with young and healthy people who typically rid themselves of the virus through the upper respiratory mucosa.
“Therefore, in the young and healthy, the encoding-based COVID-19 vaccines will transfect a far more diverse set of tissues than infection by the virus itself,” they concluded.
Data Suggest Risks of COVID-19 Vaccines Far Outweigh Low Efficacy
Although it’s claimed COVID-19 vaccines have saved millions of lives, this belief is founded upon an early 2020 infection fatality rate in China, modeling estimates produced by vaccine manufacturers, and a false assumption vaccines would protect against infection and transmission. Even Pfizer admitted its phase 3 clinical trial didn’t assess viral transmission. Yet health authorities, regulatory agencies, medical publications, and the media continue to claim vaccines are effective.To accurately assess the efficacy of gene-based COVID-19 vaccines, the researchers said there would need to be long-term studies between the vaccinated and unvaccinated individuals, which cannot occur because Pfizer, Moderna, AstraZeneca, and Janssen vaccinated their control group who were initially administered placebos.
There is currently only one worldwide control group, and data show that the unvaccinated cohort faired better than expected. Australian data from December 2022 show the unvaccinated barely exist in hospitalization data, whereas the most vaccinated are overrepresented. The data “do not suggest significant efficacy against hospitalization, ICU admission and death, at least after the emergence of the Omicron strain,” researchers concluded. Instead, the data indicate a relationship between more vaccine doses with severe COVID-19, and increased all-cause mortality that coincides with the rollout of vaccines, they said.