Theranostics. Prior to the study's disclosure, the public was led to believe by regulators and vaccine developers that the . 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. Some of the protein will go to the local draining lymph node in order to activate the immune system., Please consider leaving a comment on the FDA petition to revoke the EUA & prevent licensure of the COVID injections. . doi: 10.1371/journal.pone.0135389. It is a toxin that can cause damage in our body if it gets into circulation. (a) Number of cell-based therapeutic product in cell formulation and number of cell-based therapeutic product with or without biodistribution study in (b) cell-suspension CTP and (c) tissue or cell-sheet CTP (refer to Supplementary Table1). AAVs) through secretions or excreta from the animal model or patient. As part of that research, he and a team of international scientists requested a Freedom of Information Act (FOIA) access to Pfizers biodistribution study from the Japanese regulatory agency. As of August 23, 2021, the Pfizer-BioNTech inoculation is now approved under the brand name Comirnaty. Essentially, the assumption behind COVID-19 vaccines is their ability to enable the cells in our bodies to produce spike protein. The first section is labeled: SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of pharmacokinetic study If the damage is serious enough, uncontrolled cell death can occur, which in turn leaks mitochondrial DNA (mtDNA) into your bloodstream.13, Aside from being detected in cases involving acute tissue injury, heart attack and sepsis, freely circulating mtDNA has also been shown to contribute to a number of chronic diseases, including systemic inflammatory response syndrome or SIRS, heart disease, liver failure, HIV infection, rheumatoid arthritis and certain cancers.14 As explained in COVID-19: A Mitochondrial Perspective:15. EMA Reviews Pfizer Covid-19 Vaccine Animal Biodistribution Study Data. Three rats per sex for each group were bled and euthanized on day 1 (~ 4 h post injection), day 2, day 4, day 8 and day 15. See the post about the approval for details. "We made a big mistake," Bridle says. 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. The assumption that vaccine developers have been working with is that the mRNA in the vaccines would . Since spike proteins cause the coronavirus infection, they are the catalyst used in COVID-19 vaccines. Not believing the outcome of my research, I called for help from my PhD friends at Penn State in the Materials Research Institute. It is important that your sauna is hot enough (around 170 degrees Fahrenheit) and does not have high magnetic or electric fields. A biodistribution study was conducted using ddY mice (male, 5 weeks old). What is the clinical outcome? Over 48 hours, distribution from the injection site to most tissues occurred, with the majority of tissues exhibiting low levels of radioactivity. Its very disconcerting. A reduction in platelet count, known as thrombocytopenia, is a reliable sign that blood clots are forming in your system, as the platelets are being used up in the process. SARS coronavirus 2 (SARS-CoV-2) enters cell by attaching to angiotensin converting enzyme 2 (ACE2) receptors on cell surface Following infection, there is internalization and downregulation of ACE2 receptors. Women have reported changes in menstruation after taking mRNA vaccines. Biodistribution of nanoencapsulated bioactive compounds is primarily determined by the size, shape, chemical composition and surface properties of the encapsulating nanoparticle, and, thus, less dependent on the physicochemical properties of the active pharmaceutical ingredient encapsulated. Genetics Genetics (specified analyses) are not evaluated in this study. Once in your blood circulation, the spike protein binds to platelet receptors and the cells that line your blood vessels. It is important to pay attention to what is going on here. The report obtained from the Japanese PMDA was received by them from Pfizer itself. And yet Dr. Byram Bridle and Dr. Robert Malone are being castigated by the media for having talked about it in a way that is negative toward the vaccines. Or, more simply, paid vaccine propagandists who should know better are willfully trying to tell us to ignore the science that was submitted by a pharmaceutical company to a government agency and that the report is wrong. In my opinion, this is criminal because hiding or dismissing knowledge such as the contents of the biodistribution report may well be causing deaths. Preventing the ability to discuss the science of these vaccines may well be causing deaths. Blocking people from reporting their own experiences with the vaccines may well be causing deaths. Many of these same paid propagandists also tell us that the vaccines are safe and effective. This actually is a crime. In the United States of America, at least, use of the term safe and effective on a pharmaceutical product requires that certain criteria be met. Those criteria have not been met for any of the COVID-19 vaccines. All of the COVID-19 vaccines are still undergoing testing. Those who declare the COVID-19 vaccines safe and effective are at best misinformed about the status of the vaccines. At worst, they are outright lying to us. eCollection 2020 Sep 11. 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. 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. What did the initial Pfizer biodistribution studies show? Concise review: quantitative detection and modeling the in vivo kinetics of therapeutic mesenchymal stem/stromal cells. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. Generally speaking, there are many different kinds and types of vaccines, all with the same objectivetricking a healthy body into thinking it is under attack by a particular disease so the immune system will learn to create the cells and proteins necessary to swiftly destroy the pathogen if it becomes a threat. For Vaxzevria, a single-dose intramuscular biodistribution study with AZD1222 in mice (study 514559) was submitted post-authorisation. Why are these questions surfacing now? All of these risk factors have something in common: Theyre all associated with mitochondrial dysfunction. (11 subjects out of 13 had S-protein in blood. Likewise, research within thescientific community also reveals various cardiovascular and heart problems, bleeding, and clotting when studying the disease in humans. Our toxicology study showed a benign safety profile with just the expected inflammation associated with an immune response to the vaccine. In biodistribution study, two groups of SD rats (15 rats/sex/group) were injected intramuscularly with AdC68-19S 2 10 11 vp (twofold the proposed clinical dose of 1 10 11 vp/dose) or vehicle, respectively, on day 1. Thus, there is accumulation of damaged and dysfunctional mitochondria. The Ministry of Health, Labour and Welfare . 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. 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. 2021 The Japanese Society for Regenerative Medicine. As expected with an mRNA product, the luciferase expression was transient and decreased over time. Pfizer's biodistribution study for Japanese . When blood clots completely block a blood vessel, you end up with a stroke or a heart attack. This assumption was wrong. The sections were washed with 50% EtOH (1 min4). 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. 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. My intent is to bring you facts, not conjecture or opinion. 2. That, of course, is the type that's produced in a living cell by reading off a given stretch of DNA and assembling the matching RNA, after which it goes off on its own to be fed into a ribosome which will assemble proteins based on its code, reading off by three "codon" letters at a time. -. The spike protein gets into the blood, circulates through the blood in individuals over several days post-vaccination. 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. Federal government websites often end in .gov or .mil. Assessments of shedding can be utilized . 8600 Rockville Pike As questions intensify surrounding the true origins of SARS-CoV-2, the devastating discovery that spike proteins reach the bloodstream leaves wide open the door for many other legitimate questions about the long-term safety of COVID-19 vaccinesfor example, with it accumulating in the ovaries, will we be rendering some young people infertile?Bridle concluded: We made a big mistake; we didnt realize it until now. Is there a difference between the spike protein in the virus itself and the spike protein in the vaccines in terms of effects on the body described here? As part of that research, he and a team of international scientists requested a Freedom of Information Act (FOIA) access to Pfizer's biodistribution study from the Japanese regulatory agency. Mikovits goes so far as to call the spike protein a bioweapon, as it is a disease-causing agent that demolishes innate immunity and exhausts your natural killer (NK) cells ability to determine which cells are infected and which arent. This false claim originated from: viral social media post. Is there a translated version to English of the study somewhere we can access? ), To determine the biodistribution of the LNP-formulated modRNA, the applicant did study, determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study), or the biodistribution of a [3H]-Labelled. Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. The attack causes damage to the lining, which results in inflammation. The presentation summarized EMA requirements for BD study design, which include a dosing protocol that mimics the proposed clinical protocol with appropriate safety margins (usually highest dose), assessing all relevant organs, and extension of the analysis interval until the GT product is not detected or until a plateau phase is reached. Interestingly, we recently carried our similar study of safety and biodistribution of laser-synthesized Si nanoparticles 56,74, which present another promising material for imaging and therapy . ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). 3 Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. Prions are membrane proteins and when they misfold, they form crystals in the cytoplasm resulting in prion disease. 2015 Aug 20;10(8):e0135389. Bridle emphasized that the spike protein could cross the blood-brain barrier, causing neurological damage, explaining why fatal blood clots are often seen in the brain. But, as you can see below, unlike Bridle, Politifact neglected to go beyond interviewing someone with such a huge stake in the vaccines success. Guidelines on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. Vitamin D Part I: Is Vitamin D really a vitamin? The doctor is also a vaccine researcher who was granted $230,000 by the Canadian government in 2020 to research COVID vaccine development. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. He explained that critical information has recently been discovered that centers around spike proteinsa crucial element in both the SARS-CoV-2 virus and the COVID-19 vaccines. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. Why? The mRNA enters your bloodstream and accumulates in a variety of organs, primarily your spleen, bone marrow, liver, adrenal glands and, in women, the ovaries. Indeed, for many months, weve known that the worst symptoms of severe COVID-19, blood clotting problems in particular, are caused by the spike protein of the virus. Twitter Facebook When a substance is injected into the body, tracking where it goes- its biodistribution is important to know. Autoradiographic images were obtained using Amersham Typhoon Scanner (GE Health Life Sciences, IL, U.S.A.). Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. Brief Summary: The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants. FOIA 2009 Aug;(144):3-79. This not only leads to impaired MAVS [mitochondrial antiviral signaling] response but also aggravates inflammation and cell death.. Dr. Jane Ruby and Karen Kingston both have concerns about the legality of the approval. Bridle cites research showing that laboratory animals injected with purified spike protein from SARS-CoV-2 straight into their bloodstream developed cardiovascular problems and brain damage. Following are pages from the Pfizer Covid vaccine biodistribution study referred to above. Spike Protein Is Very Dangerous, Its Cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein). After the protein piece is made, the cell breaks down the instructions and gets rid of them. The https:// ensures that you are connecting to the I want to pass it on to some doctors in Japan who have no idea about its existence. 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. In response to information not being available on the internet, a Citizen petition to the FDA was filed by 27 prominent health experts and scientists on June 1, 2021, requesting proper pharmacokinetic and biodistribution safety studies be revealed or conducted by the vaccine manufacturers. This conclusion was reached by Israeli scientists, who conducted a study that showed that there is no difference in ovarian function between vaccinated and unvaccinated women. S1A). What is the real truth? 2012 Mar;64(3):375-83. doi: 10.1002/acr.21558. Here in fact he spells out that the Japanese Pfizer biodistribution studies have found a high concentration of the Lipid Nanoparticles in the ovaries--a known result to Pfizer and the FDA . While all of this is highly problematic, there is help. It is true that some of experiments looked at the distribution of lipid nanoparticles containing an mRNA coding for Luciferase, a protein that exhibits bioluminescence allowing for visualization where the mRNA ended up. At vascular endothelium, ACE2 performs conversion of angiotensin II to angiotensin (17). PLoS One. Japanese government and Pfizer biodistribution study shows 75% of mRNA travels from injection site into blood and distributed into organs and across brain-blood barrier Trying to post again as original post was removed by automod for unknown reasons. which is it, did they or did they now know that the spike protein was a toxin/pathogenic for a long time? A total of 4,653,566 medical personnel and 5,734,023 people aged 65 and over had received at Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. Dr. Bridle, Associate Professor of Viral Immunology at the University of Guelph,received funding to develop a novel vaccine platform and is very much pro-vaccine. It was a pre-clinical biodistribution study. Why do we need it. The liver received the highest dose (0.360 mSv/MBq), followed by the gallbladder wall (0.155 mSv/MBq). I thought this would be an easy blog to write, cut and dry. Bridle explains the study absolutely refutes the premise that the COVID-19 vaccine stays in the shoulder muscle, asserting: The short answeris absolutely not. Anyway, the answer to this question unfortunately is that they go pretty much everywhere. They confirmed what I had found. So by vaccinating people, we are inadvertently inoculating them with a toxin.. 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. This is a nonprofit education and research site. Nothing whatsoever on this site is monetized, not even the Amazon links. I therefore claim fair use of materials featured here. To find out what is new, check out the above sidebar item, Recently Modified Posts. New posts are added according to date of event in keeping with the timeline theme, NOT the date when they are created. Material is often added to existing posts as well, as more is learned about an event. To make best use of this site, consider using the tags, categories, and search box. Many posts also have a See also, on this site list. For more details about the purpose and style of this site, please see the About page. Assuming that the spike protein would not enter into the circulatory system was a grave mistake, according to Bridle, who calls the Japanese data clear-cut evidence that the vaccine, and the spike protein produced by it, enters your bloodstream and accumulates in vital organs. In addition, mitochondrial damage leads to inappropriate and persistent inflammation. The EIN for the organization is 59-1630423. Luciferase signals at the injection sites, most likely reflecting distribution to the lymph nodes draining the injection sites, peaked 6h post injection with signals of approximately 10 000 times of buffer control animals. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern." Pingback: Lying to children - Change is Always Possible. Yet he was 100% correct. Shockingly, according to Bridle, the COVID-19 vaccine is different from traditional vaccines. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. For the first time ever, the Japanese Regulatory Agency recently gave Bridle and several international collaborators access to a study called the Bio-Distribution Study. The groundbreaking research presents scientists with a more reliable understanding of where COVID-19 messenger RNA (mRNA) vaccines travel in the body after being injected. Scientists discovered the SARS-CoV-2 spike protein circulating in the blood of eleven of the thirteen healthcare workers. Image . 8.8. 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). The spike protein also travel to your heart, brain and lungs, where bleeding and or blood clots can occur as a result, and is expelled in breast milk. The data from this study is not yet available in the public domain but this might provide evidence of vaccine delivery in the brain. 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. The EIN for the organization is 59-1630423. 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. So the Japanese medicines regulator had required Pfizer to do a study where they looked at how the vaccine distributed around the body, in this case of a . The results from this study supported many of the results from the biodistribution-only studies. It can cause damage in our body if it gets into circulation The spike protein on its own is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation.. Bookshelf In the same way, its quite possible COVID-19 vaccines may promote Parkinsons and other human prion diseases such as Alzheimers. Tags:Japan Pfizer spike proteins vaccines. I am giving you the technical version so you can see for yourself the actual data reviewed by EMA. Adams AJ, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. Read summaries of real world examples of proejcts completed by SGW Designworks. Breastfeeding women also need to know that both the vaccine and the spike protein are being expelled in breast milk, and this could be lethal for their babies. The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines. This analysis is not usually conducted on ex vivo transduced cells. Careers. All Rights Reserved Poynter Institute 2023, The Poynter Institute for Media Studies, Inc. is a non-profit 501(c)3. New Peer Reviewed Study on COVID-19 Vaccines Suggests Why Heart Inflammation, Blood Clots and Other Dangerous Side Effects Occur. Whats more, TrialSite News reports6 that Pfizer documents submitted to the European Medicines Agency [EMA] reveal the company did not follow industry-standard quality management practices during preclinical toxicology studies as key studies did not meet good laboratory practice (GLP)., Neither reproductive toxicity nor genotoxicity (DNA mutation) studies were performed, both of which are considered critical when developing a new drug or vaccine for human use. Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D. Our democracy no longer represents the people. Biodistribution (BD) analysis is performed to determine the distribution and the persistence of the vector/virus to target and nontarget tissues following direct in vivo administration in animals. 2022 Apr 7;10(4):869. doi: 10.3390/biomedicines10040869. The more we learn about the COVID-19 vaccines, the worse they look. This document . 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. The problems now surfacing matter greatly, as they significantly alter the risk-benefit analysis underlying the vaccines emergency use authorization. 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. I wanted links for my wife who is Japanese and could not understand my resistance to them. government site. The signal decreased slowly during the first 72 hours and after 6 and 9 days the signals were further weakened to approximately levels of 18 and 7 times the signals obtained from animals injected with buffer control. In fragile patients receiving the blood, the damage could be lethal. The designers of the COVID-19 vaccines expected the contents of a jab to remain in the muscular tissue where they were injected, usually an arm. This assumption was wrong. 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