Title : Did Pfizer Fail to Perform industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?
link : Did Pfizer Fail to Perform industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?
Did Pfizer Fail to Perform industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?
One could access the information below via a previous post here.
Not sure how many did? So feeling as if this piece deserves more attention, excerpts are being featured below:
TrialSite has learned of material information regarding mRNA vaccine safety revealed by a freedom of information act (FOIA) request filed by a group of Canadian physicians. These doctors have become concerned about COVID-19 mRNA vaccine safety. This new safety information involves the Pfizer mRNA-based vaccine known as BNT162b2 or “Comirnaty.” The FOIA documents reveal animal study results demonstrating that the Pfizer mRNA-based vaccine does not remain at the injection site, but rather appears to spread widely after injection. According to the documents, pre-clinical studies show that the active part of the vaccine (mRNA-lipid nanoparticles), which produce the spike protein, spreads throughout the body and is then concentrated in various organs, including the ovaries and spleen. The FOIA-produced data sets are incomplete, so the full meaning of these data cannot be determined at this time. TrialSite has also learned via regulatory documents that apparently (at least in their European Medicines Agency submission), Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies during vaccines, as key studies did not meet good laboratory practice (GLP). The full panel of industry-standard reproductive toxicity and genotoxicity studies were apparently also not performed. But does this matter in light of the risk-benefit analysis associated with regulatory emergency use authorization (EUA)?
Among the most critical tests, which must be performed prior to testing any drug or vaccines in a human being, is whether it can cause mutations in the DNA (genotoxicity), or whether it could cause problems with cells or tissues of the reproductive tract – including ovaries (reproductive toxicity). In the case of the Pfizer COVID mRNA vaccine, these newly revealed documents raise additional questions about both the genotoxicity and reproductive toxicity risks of this product. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. Furthermore, in key studies designed to test whether the vaccine remains near the injection site or travels throughout the body, Pfizer did not even use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA producing the luciferase protein.
These new disclosures seem to indicate that the U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine.
It is certainly understandable why the vaccine was rushed into use as an experimental product under emergency use authority, but these new findings suggest that routine quality testing issues were overlooked in the rush to authorize use. People are now receiving injections with an mRNA gene therapy-based vaccine, which produces the SARS-CoV-2 spike protein in their cells, and the vaccine may be also delivering the mRNA and producing spike protein in unintended organs and tissues (which may include ovaries)
How mRNA Vaccines are Believed to Work
The current mRNA vaccines are theorized to act locally in draining lymphoid tissue. Formulated lipid nanoparticles that contain mRNA able to produce the spike protein are syringe injected into a muscle such as the deltoid (shoulder muscle). Once the injection occurs, the muscle cells near the injection site are impacted by the mRNA-based vaccine (e.g. the lipid nanoparticles), while much of the dose moves into the intracellular fluid surrounding the muscle cells and consequently drains to lymph nodes
According to this theory, a properly functioning mRNA-based vaccine is delivered into and drives production of the SARS-CoV-2 Spike protein in muscle and lymph node cells. The cells then produce the Spike protein, which is then moved to the surface of these cells where it becomes attached. The foreign virus Spike protein then triggers the immune system to recognize and attack any cell in the body that is either infected by SARS-CoV-2 or has Spike protein on its surface.
The same general scenario applies to all mRNA-based vaccines as well as recombinant adenoviral vectored vaccines (such as the J&J vaccine) designed to use gene-therapy technology to express Spike protein in cells and tissues. This general strategy is designed to reduce the risk that any residual vaccine dose that does somehow end up in the bloodstream (or organs and tissues) ends up not being a safety risk due to unintended biologic effects. Spike protein will remain affixed to cell surfaces, and therefore is not released into the blood where circulating Spike might cause problems by binding to its natural target, ACE-2 receptors. However, any cell that has Spike protein (or protein fragments) anchored on its membrane or displayed on MHC antigen-presenting molecules becomes a target for vaccine-activated immune cells and antibodies, which would then attack, damage or kill those cells in the same way that SARS-CoV-2 virus-infected cells would be attacked. In other words, if very active mRNA delivery particles or recombinant adenoviral-vectored vaccines spread throughout the body, the resulting production of the vaccine antigen (Spike, in this case) will both stimulate immunity and also cause those same cells to be attacked by the immune system. If this actually happens, the resulting “vaccine reactogenicity” could resemble clinical symptoms seen with autoimmune syndromes.
EMA Pfizer/BioNTech Vaccine Distribution Studies
Upon inspection of the EMA summary document, TrialSite found evidence suggesting that the issue of biodistribution and pharmacokinetics of the “Comirnaty” BNT162b2 vaccine was not thoroughly examined in accordance with industry norms prior to the EMA review of the BNT162b2 IND/CTD. The reviewers share an explicit admission that “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Rapporteur (Filip Josephson) and Co-Rapporteur (Jean-Michael Race) suggest, however, that Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and suggest that “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies that were performed and submitted were non-GLP. Additionally, the EMA document states “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350, indicate a broader biodistribution pattern.” This EMA observation corresponds with what appears to be a growing number of adverse events and aligns with data TrialSite observed via the FOIA showing concentrations of LNP-formulated RNAs in the spleen, for example.
Repeating “Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain"
When these LNP- formulated RNA’s distribute themselves to non specific organs the immune system attack these organs in order to fight the infection
In other words, if very active mRNA delivery particles or recombinant adenoviral-vectored vaccines spread throughout the body, the resulting production of the vaccine antigen (Spike, in this case) will both stimulate immunity and also cause those same cells to be attacked by the immune system
If you look through the Canadian Covid Death and Injury report you will notice there is liver damage, heart damage, spontaneous miscarriage, fetal growth restriction, kidney injury, brain injury etc., I’ve no reason to think these harmful effects are not taking place globally. Based on the information at hand this looks to be directly related to the vaccine.
We can also take a first, second or third look at this previous report and watch the video
Neuroscientist Chris Shaw PhD shares his concerns about the mRNA #Covid19 vaccines and explains Moderna’s own data demonstrating mRNA can cross the blood-brain barrier.
EMA Pfizer/BioNTech Vaccine Distribution Studies
“Upon inspection of the EMA summary document, TrialSite found evidence suggesting that the issue of biodistribution and pharmacokinetics of the “Comirnaty” BNT162b2 vaccine was not thoroughly examined in accordance with industry norms prior to the EMA review of the BNT162b2 IND/CTD. The reviewers share an explicit admission that “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Rapporteur (Filip Josephson) and Co-Rapporteur (Jean-Michael Race) suggest, however, that Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and suggest that “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies that were performed and submitted were non-GLP. Additionally, the EMA document states “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350, indicate a broader biodistribution pattern.”Of course you should take the entire piece in at the available, originating link
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