Media Continue to Lie About Gene Therapy Jab - One in Three Shots Were Placebos
Since mRNA shots contain several novel technologies, they should be subject to more controls than conventional vaccines. Yet they aren’t. In fact, they’re not covered by any specific regulations
Since mRNA shots contain several novel technologies, they should be subject to more controls than conventional vaccines. Yet they aren’t. In fact, they’re not covered by any specific regulations
mRNA COVID shots are gene therapy, but not regulated as such. By slapping a fraudulent “vaccine” label on gene therapies, they are being developed outside of the regulatory framework that governs them
An alternative framework that could regulate mRNA shots would be Type1A pro-drug regulations, but they’re not being regulated as such either
Per the U.S. Food and Drug Administration’s definition, gene therapy covers two modes of operation. It either alters the biological properties of living cells, and/or modifies your genes. This means that even if the product does not modify your genes, it’s still a gene therapy if it modifies the properties of cells, which is what the COVID shots do
Data show 1 in 3 Pfizer COVID shots administered in Denmark were placebo — and regulators must have known about it
While the COVID-19 shots are referred to as “vaccines,” they do not meet the classical definition of a vaccine. Health authorities needed to change the definition1 to accommodate the COVID shots and shut down the argument that, as experimental gene therapies, they may be riskier than traditional vaccines.
Meanwhile, based on the U.S. Food and Drug Administration’s definition2,3 of “gene therapy” they’re clearly gene therapies, and both Moderna4 and BioNTech5 acknowledge this in their Securities and Exchange Commission (SEC) registration statements.
In a 2014 paper,6 BioNTech founder Ugur Sahin also stated that “One would expect the classification of an mRNA drug to be a biologic, gene therapy or somatic cell therapy.”
Publicly, however, drug makers, regulators and, of course, the media, have been going to great lengths to make sure people don’t think of them that way. Now, a peer-reviewed paper7,8 has weighed in on the controversy, stressing that mRNA COVID shots “should be labeled as gene therapy.”
mRNA Shots Are Gene Therapy, but Not Regulated as Such
As noted in this paper, published in the International Journal of Molecular Science, June 22, 2023:
“COVID-19 vaccines were developed and approved rapidly in response to the urgency created by the pandemic. No specific regulations existed at the time they were marketed. The regulatory agencies therefore adapted them as a matter of urgency.
Now that the pandemic emergency has passed, it is time to consider the safety issues associated with this rapid approval. The mode of action of COVID-19 mRNA vaccines should classify them as gene therapy products (GTPs), but they have been excluded by regulatory agencies.9
Some of the tests they have undergone as vaccines have produced non-compliant results in terms of purity, quality and batch homogeneity. The wide and persistent biodistribution of mRNAs and their protein products, incompletely studied due to their classification as vaccines, raises safety issues.
Post-marketing studies have shown that mRNA passes into breast milk and could have adverse effects on breast-fed babies. Long-term expression, integration into the genome, transmission to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be studied in light of the adverse events reported in pharmacovigilance databases.
The potential horizontal transmission (i.e., shedding) should also have been assessed. In-depth vaccinovigilance should be carried out. We would expect these controls to be required for future mRNA vaccines developed outside the context of a pandemic.”
mRNA Shots Do Not Qualify as Vaccines
Banoun goes on to review the definitions of vaccine and gene therapy as listed by the FDA, the European Medicines Agency (EMA), the World Health Organization and the French Agence Nationale de Sécurité du Médicament (ANSM). Of these, the ANSM and EMA specify that a vaccine must contain one or more antigens.
Based on that definition, mRNA shots do not qualify as vaccines in France and Europe, because they don’t contain antigens. The active substance that elicits a downstream immune response is mRNA. The mRNA instructs your cells to produce the antigen. The mRNA is not an antigen in and of itself. In the case of COVID-19, the antigen being produced downstream is a modified SARS-CoV-2 spike protein.
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