Author is a Pharmacist biologist, Former Inserm researcher, Member of the Independent Scientific Council, Marseille 13000, France.
"Abstract
... Vaccine mRNA-carrying lipid nanoparticles spread after injection throughout the body according to available animal studies and vaccine mRNA (naked or in nanoparticles or in natural exosomes) is found in the bloodstream as well as vaccine spike in free form or encapsulated in exosomes (shown in human studies). Lipid nanoparticles (or their natural equivalent, exosomes or extracellular vesicles (EVs)) have been shown to be able to be excreted through body fluids (sweat, sputum, breast milk) and to pass the transplacental barrier. These EVs are also able to penetrate by inhalation and through the skin (healthy or injured) as well as orally through breast milk (and why not during sexual intercourse through semen, as this has not been studied). It is urgent to enforce the legislation on gene therapy that applies to mRNA vaccines and to carry out studies on this subject while the generalization of mRNA vaccines is being considered...
Introduction
... The first published testimony of vaccine shedding that I saw dates from December 2021 and is that of Dr Ray Sahelian: he reported cases of medical or scientific colleagues who had observed symptoms close to those of the adverse effects of the vaccine after having been in contact with freshly vaccinated persons...
At the beginning, this type of testimony did not seem very credible to me, but they accumulated and in October 2021, I received a testimony from a group of French caregivers: they observed a stroke in a 7-year-old child with no risk factors and whose parents had been freshly vaccinated ...
Regulations regarding the excretion of gene therapies by regulatory agencies
... there is strict regulation of gene therapy products ...
The 2015 FDA document on Gene Product Shedding Studies concerns gene therapies, which are defined as 'all products that exert their effects by transcription and/or translation of transferred genetic material and/or by integration into the host genome and that are administered in the form of nucleic acids, viruses or genetically modified microorganisms'. In this sense mRNA vaccines are indeed gene therapy products and should have been submitted to these excretion studies...
Based on an EMA [European Medicines Agency] document on excretion of gene products, mRNA vaccines meet the definition of GMTPs (gene therapy medicinal products), however their designation as a 'vaccine' has allowed them to escape the clinical trial requirements for gene products that relate in particular to excretion potential, biodistribution, pharmacodynamics, genotoxicity, insertional mutagenesis ...
Conclusion
There are many testimonies of non-vaccinated persons who experienced symptoms identical to the adverse effects of the vaccine after having been in contact with freshly vaccinated persons. A study shows an excess of mortality in the non-vaccinated age groups when vaccination campaigns begin, which could be explained by a phenomenon of transmission of the vaccine or its products.
It is important not to neglect these testimonies because the required studies of pharmacokinetics and in particular of excretion of the vaccine and its products have not been carried out in spite of the regulations in force for gene therapies, which include mRNA vaccines according to the definition of these gene products."
© 2022 By Author(s). Published by TMR Publishing Group Limited. This is an open access article under the CC-BY license. (https://creativecommons.org/licenses/by/4.0/ )