(BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. From pre-concept to manufacturing startup. The current study investigated SARS-CoV-2 viral load, biodistribution and anti-SARS-CoV-2 antibody formation in patients suffering from severe corona virus disease 2019 (COVID-19) induced acute respiratory distress syndrome (ARDS). An official website of the United States government. Click to access 672212000_30300AMX00231_I100_1.pdf, Pingback: Vaccine Shedding: The Harm For Those Who Choose NOT To Be Vaccinated The Courtenay Turner Podcast. Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of MRNA-1273 Vaccine Recipients. Pfizer's biodistribution study for Japanese . Thus, there is accumulation of damaged and dysfunctional mitochondria. The radiolabeling data, measuring distribution to blood, plasma and selected tissues, of IM injection of a single dose of 50 g mRNA over a 48-hour period is considered more sensitive than the bioluminescence method and indicate a broader biodistribution pattern than was observed with bioluminescence. The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines, The assumption that vaccine developers have been working with is that the mRNA in the vaccines would primarily remain in and around the vaccination site. 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This is a problem, because rather than instructing your muscle cells to produce the spike protein (the antigen that triggers antibody production), spike protein is actually being produced inside your blood vessel walls and various organs, where it can do a great deal of damage. https://www.regulations.gov/docket/FDA-2021-P-0521/document. Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Before High Mutational Heterogeneity, and New Mutations in the Human Coagulation Factor V Gene. o or the biodistribution of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation (rat study). The "Japanese biodistribution study," referenced in the online article appears to be a Japanese translation of a Pfizer toxicology and biodistribution study, which shows nothing like what is being claimed. Bridle details further, explaining: The assumption until now has been that these vaccines behave like all of our traditional vaccines; that they dont go anywhere, they stay in our shoulder. Implementation status of clinical biodistribution by formulation in locally administered product group as of September 2018. In fragile patients receiving the blood, the damage could be lethal. 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. Playing Hardball in Government and Politics, Nuclear War At the Abyss of Mass Extermination, Pfizer Bio-Distribution Study Submitted to the Japanese Government, Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizers biodistribution study from the Japanese regulatory agency. Japan has administered COVID-19 vaccine doses to more than 10 million people, the Prime Minister's Office said Wednesday, as the country tries to speed up inoculations that are lagging far behind other developed countries. Now, we have clear-cut evidence that the vaccines that make the cells in our deltoid muscles manufacture this protein, [we now know] the vaccine itself plus the protein gets into blood circulation. Number of biodistribution (BD) studies in cell-based therapeutic product as of September 2018 in comparison among (a) local or systemic administration product, (b) commercialized or product in clinical phases, (c) biodistribution measurement modalities, (d) clinical phases of development, (e) used animal species and (f) measurement modalities and biodistribution study duration (refer to Supplementary Table1). PLoS One. Copyright 2023 Pandemic Timeline. Over 48 hours, distribution from the injection site to most tissues occurred, with the majority of tissues exhibiting low levels of radioactivity. Explanation: When you receive the covid vaccine, it will not impair the function of your ovaries, just as the coronavirus will not. Please send me all info on any new updates. Why the confusion? Increased oxidative stress may lead to endothelial dysfunction and aggravate systemic and local inflammation, thus contributing to acute lung injury, cytokine storm, and thrombosis seen in severe COVID-19 illness , A recent algorithm showed that majority of SARS-CoV-2 genomic and structural RNAs are targeted for mitochondrial matrix. Brindle, who stated the importance of sharing this new information openly, recently visited On Point with Alex Pierson and spoke at length on the scary situation facing humanity as the push to vaccinate the global population against SARS-CoV-2 gains momentum. What is the real truth? Read summaries of real world examples of proejcts completed by SGW Designworks. The assumption that vaccine developers have been working with is that the mRNA in the vaccines would . The liver received the highest dose (0.360 mSv/MBq), followed by the gallbladder wall (0.155 mSv/MBq). In this work, we have confirmed results in the literature and . Support responsible news and fact-based information today! doi: 10.1371/journal.pone.0135389. Change), You are commenting using your Twitter account. After the protein piece is made, the cell breaks down the instructions and gets rid of them. *, o LNP=LipoNanoParticle which carries the mRNA, o LC-MS/MS is liquid chromatography with tandem mass spectrometry. The mean concentrations and tissue distribution pattern were broadly similar between the sexes. Future Perspectives for Factor V Deficiency Using Recombinant and Advanced Therapies. Consistent data shows the virus is less severe than influenza in children, strengthening the argument of do kids need the vaccine? Voicing his concern, Bridle asserts: Thats not how this is supposed to work; our kids should not be the guinea pigs. The signals from the liver region peaked 6h post injection and decreased to background levels 48h after injection. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. Keywords: It is a toxin that can cause damage in our body if it gets into circulation. Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D. Not so. DO NOT forget Japanese biodistribution study looking at lipid nano-particles in rats & how they bio-accumulated in first 48 hours post administration; understand that this links direct to COVID jabs Dr. Byram Bridle was attacked for his work showing that content of the COVID VACCINE did not stay in the injection site (arm) but leeched into the . The site is secure. This site needs JavaScript to work properly. 2015;99(23):99079922. Study: Adverse events following COVID-19 virus vaccination in Japanese young population: The first cross-sectional study conducted by a questionnaire survey after the first-time-injection. The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. The study 514559 was aimed to examine the biodistribution of ChAdOx1 nCoV-19 in bone marrow, brain, spinal cord, sciatic nerve, and other body tissues. The attack causes damage to the lining, which results in inflammation. -, Brooks A., Futrega K., Liang X., Hu X., Liu X., Crawford D.H.G. Its very disconcerting We have known for a long time that the spike protein is a pathogenic protein. Parkinsons disease is a prion disease that has been traced back to prions originating in the spleen, that then travel up to the brain via the vagus nerve. Arthritis Care Res (Hoboken). Hello do you have an updated link to the old Japanese Pfizer study? . Once it gets in the blood, it accumulates in a number of tissues such as the spleen, the bone marrow, the liver, the adrenal glands. Human organ radiation dosimetry is shown in Table 2. 2011 Oct;17(10):881-90. doi: 10.1089/acm.2010.0481. The readouts were performed at 6h, 24h, 48h, 72h, 6d and 9d post IM injection (intended clinical route) in the right and left hind leg with each 1 g (total of 2g) of LNP-formulated luciferase RNA. In what organs can you find the vaccine? This does not mean the animal studies were not done. It can also lead to bleeding, and of course, the heart is involved, which is part of the cardiovascular system, so that is why we are seeing heart problems., Please take a moment to complete our pop quiz, to assess your level of moral reasoning on whether vaccinating children against #COVID19 is right or wrong. Shedding is the dissemination of the viral vectors (e.g. Clipboard, Search History, and several other advanced features are temporarily unavailable. All of this also suggests that for individuals who are at low risk for COVID-19, children and teens in particular, the risks of these vaccines far outweigh the benefits. Information on the biodistribution (BD) of cell therapy products (CTPs) is essential for prediction and assessment of their efficacy and toxicity profiles in non-clinical and clinical studies. They confirmed what I had found. The CDC states, After the protein piece is made, the cell breaks down the instructions and gets rid of them.** However, a Japanese document of the Pfizer vaccine data showed biodistribution beyond the local injection site, with distribution highest in the ovaries at 48 hours. Thus, the absence of safety pharmacology studies is endorsed by the CHMP, Committee for Medicinal Products for Human Use. Methods: This is a retrospective single-center study in 23 patients with COVID-19-induced ARDS. Using mRNA programmed to produce luciferase protein, as well as mRNA tagged with a radioactive label, Pfizer showed that the majority of the mRNA initially remain near the injection site, but within hours become widely distributed within the body.9. SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 PFIZERCONFIDENTIAL Page 3 1. BNT162b2BioNTechBNT162PfizerPF-07302048 Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells. DNA Extraction Method Affects the Detection of a Fungal Pathogen in Formalin-Fixed Specimens Using qPCR. The Ministry of Health, Labour and Welfare . We thought the spike protein was a great target antigen; we never knew the spike protein itself was a toxin and was a pathogenic protein. 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. Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. Concise review: quantitative detection and modeling the in vivo kinetics of therapeutic mesenchymal stem/stromal cells. The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. SARS-CoV-2 MRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of Pharmacokinetic Study. It also was featured in a fact check by The Poynter Institutes Politifact,2 which pronounced Bridles findings as false after interviewing Dr. Drew Weissman,3 a UPenn scientist who is credited with helping to create the technology that enables the COVID mRNA vaccines to work. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. Guidelines on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. The biodistribution study obtained by Bridle showed lipid nanoparticles from the vaccine did not stay in the deltoid muscle where they were injected as the vaccine's developers claimed would happen, but circulated throughout the body and accumulated in large concentrations in organs and tissues, including the spleen, bone marrow, liver, adrenal When that happens, it can do one of two things: it can either cause platelets to clump, and that can lead to clottingthats exactly why weve been seeing clotting disorders associated with these vaccines. The argument now becomes whether that approval was legal. It also modulates the adhesion of platelets to the endothelium. When administered, COVID-19 vaccines are injected into the shoulder musclenot into the blood. Scientists discovered the SARS-CoV-2 spike protein circulating in the blood of eleven of the thirteen healthcare workers. Please read and agree to the disclaimer before watching this video.. SARS-COV-2 Spikes in Ovaries from Pfizer-BioNTech Vaccine?There has been some uncertaint. When that happens, it can cause platelets to clump together, resulting in blood clots, and/or cause abnormal bleeding, Pfizer documents submitted to the European Medicines Agency also show the company failed to follow industry-standard quality management practices during preclinical toxicology studies and that key studies did not meet good laboratory practice standards. Spike protein does not attack anything, it only aims to activate the immune response, it is not the same as coronavirus spike protein and after vaccination, it is created in a dose 100 thousand times lower than in viral infection. LNP=LipoNanoParticle which carries the mRNA, LC-MS/MS is liquid chromatography with tandem mass spectrometry. The study is titled, "Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel-group comparison . 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