Change), You are commenting using your Twitter account. 2. 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. SARS-CoV-2 MRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of Pharmacokinetic Study. We made a big mistake, Bridle says. This is in contrast to current thinking the mRNA vaccine is quickly broken down at its site of injection in the arm implying no distribution to other organs. I wanted links for my wife who is Japanese and could not understand my resistance to them. Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations. https://www.regulations.gov/docket/FDA-2021-P-0521/document. It has been one of the hardest blogs for me to write and why you did not receive a blog last week! The sections were washed with 50% EtOH (1 min4). Pfizer report_Japanese government.pdf Report ; Share. All Rights Reserved. To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. It is a toxin that can cause damage in our body if it gets into circulation. We never knew the spike protein itself was a toxin and was a pathogenic protein. 1. -, Brooks A., Futrega K., Liang X., Hu X., Liu X., Crawford D.H.G. The EIN for the organization is 59-1630423. You can also boost your sulfate by taking Epsom salt baths. The European Medicine Agency (EMA) is an agency of the European Union (EU) in charge of the Evaluation and Supervison of Medicinal Products. Recently, there has been speculation regarding potential safety signals associated with COVID-19 mRNA vaccines. Twitter Facebook This is about as diabolical as it gets. A biodistribution study of the Pfizer Covid-19 injection suggests a suspension of the use of mRNA 'Vaccines' is urgently required and blood donor organisations need to take a long hard look at their policies surrounding the acceptance of donations of blood from people who have received an mRNA based Covid-19 injection. Shedding is the dissemination of the viral vectors (e.g. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. Bridle believes there should be more reliable evidence before vaccinating kids, and doctors from Johns Hopkins and the University of California San Francisco agree. 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. Biodistribution; Cell therapy product; Imaging; MRI; PET; SPECT; qPCR. Technically, it is not following the mRNA vaccine itself but following where the LNP container-luciferine goes as a surrogate to understanding where the mRNA may go. It also has reproductive toxicity, and Pfizers biodistribution data show it accumulates in womens ovaries, Once in your blood circulation, the spike protein binds to platelet receptors and the cells that line your blood vessels. The biodistribution was also studied in rats using radiolabeled LNP and luciferase modRNA (study 185350).. This information is found on the internet leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer. 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. Well, back in May 2021, I, along with some international colleagues, looked at a document that Pfizer had submitted to the Japanese health regulatory agency. Nonetheless, he insists science must be properly performed and then followed carefully before entering into the public rollout of vaccines. 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. What is the length of time the vaccine exists in the body after vaccination? official website and that any information you provide is encrypted 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.. The mouse study used three female BALB-c mice per group and luciferase protein expression was determined by in vivo bioluminescence readouts using an In Vivo Imaging System (IVIS) following injection of the luciferase substrate luciferine. That is, luciferase RNA inclusion LNP was intramuscularly administered to the left and right hind limbs of mice at a dose of 1 g RNA (2 g RNA in total). However, while the spike protein found in the virus is bad, the spike protein your body produces in response to the vaccine is far worse. 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. A study document obtained from the Japanese regulatory agency shows that the vaccine contents enter the bloodstream and travel to the various organs.Lab animals injected with purified spike protein into their bloodstream developed cardiovascular problems, and the spike protein was also demonstrated to cross the blood brain barrier and cause damage to the brain. Find the original research and move on! -, von der Haar K., Lavrentieva A., Stahl F., Scheper T., Blume C. Lost signature: progress and failures in in vivo tracking of implanted stem cells. (LogOut/ The results from this study supported many of the results from the biodistribution-only studies. Japan shares biodistribution study of Pfizer COVID-19 vaccine May 27, 2021 Tags: Japan Pfizer spike proteins vaccines 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. 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). 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. 8.8. This review aimed at surveying international and Japanese trends concerning the BD study for CTPs and the following subjects were investigated, which were considered particularly important: 1) comparison of guidelines to understand the regulatory status of BD studies in a global setting; 2) case studies of the BD study using databases to understand its current status in cell therapy; 3) case studies on quantitative polymerase chain reaction (qPCR) used primarily in non-clinical BD studies for CTPs; and 4) survey of imaging methods used for non-clinical and clinical BD studies. Why are these questions surfacing now? Dr. Byram W. Bridle, Ph.D. says the he and several colleagues gained access to a first-of-its-kind "biodistribution" study out of Japan showing that even when injected in muscle tissue in the arm, the mRNA (messenger RNA) injections from Moderna and Pfizer-BioNTech cause the production of spike proteins that more often than not get into the This document . Radioactivity was detected in most tissues from the first time point (0.25 h) and results support that injections site and the liver are the major sites of distribution. 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. See the post about the approval for details. Canadian vaccine expert Dr. Byram Bridle recently spoke of the terrifying reasons serious side effects, including heart inflammation and vaccine-induced immune thrombotic thrombocytopenia (VITT), may occur in those who have received the COVID-19 vaccine. Technically, it is not following the mRNA vaccine itself but following where the LNP container-luciferine goes as a surrogate to understanding where the mRNA may go. We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. This does not mean the animal studies were not done. Pfizer's now infamous biodistribution study that was part of a pharmacokinetic package done for the Japanese government found that the LNP's go everywhere and anywhere, with special affinity for the liver, spleen, and ovaries. Nanoparticles with positively charged surfaces tend to accumulate in the liver, lung, and spleen [ 34 ]. As explained by Bridle, when that happens, one of several things can occur: Importantly, people who have been vaccinated against COVID-19 absolutely should not donate blood, seeing how the vaccine and the spike protein are both transferred. It is a toxin. At first glance, this information seems relatively straightforward. This assumption was wrong. Why? Is there a translated version to English of the study somewhere we can access? Proves the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver,. See this image and copyright information in PMC. Methods: This is a retrospective single-center study in 23 patients with COVID-19-induced ARDS. Hello do you have an updated link to the old Japanese Pfizer study? 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. After spending 20 hours of research, I found there are. The short answer is: absolutely not. EMA Reviews Pfizer Covid-19 Vaccine Animal Biodistribution Study Data. In what organs can you find the vaccine? The first section is labeled: SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of pharmacokinetic study 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. It was a pre-clinical biodistribution study. Among many other things, the glycocalyx contains a wide variety of anticoagulant factors, including tissue factor inhibitor, protein C, nitric oxide and antithrombin. 2015;43(1):115125. The data from this study is not yet available in the public domain but this might provide evidence of vaccine delivery in the brain. Rightly, Bridle is extremely troubled about the current drive to vaccinate children against COVID-19, recently stating insufficient evidence exists to claim the benefits outweigh the risk of vaccinating the younger population. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. Fill in your details below or click an icon to log in: You are commenting using your WordPress.com account. The biodistribution was also studied in rats, using radiolabeled LNP and luciferase modRNA (study 185350. The bottom line is mRNA Covid vaccines are still considered experimental by the FDA as research continues to be done. Fact Sheet for Healthcare Providers Administering Vaccine [Pfizer-BioNTech]. Pfizer also found that the LNP-encapsulated . The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. It is important that your sauna is hot enough (around 170 degrees Fahrenheit) and does not have high magnetic or electric fields. Focus on certified-organic foods to minimize your glyphosate exposure, and include plenty of sulfur-rich foods to keep your mitochondria and lysosomes healthy. 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. . Remember to check the date when the fact-check you are reading was published before sharing it. 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. It is a toxin that can cause damage in our body if it gets into circulation. 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. But, as you can see below, unlike Bridle, Politifact neglected to go beyond interviewing someone with such a huge stake in the vaccines success. J Altern Complement Med. Its the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination, Bridle told Pierson.10. -. The argument now becomes whether that approval was legal. . Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. The Japanese biodistribution study of Pfizer's mRNA vaccine has also found that 0.02% and 0.009% of the vaccine administered dose ended up in the brain at 2-hour and 48-hour, respectively: For an LNP-mRNA vaccine, DNA vaccine, or recombinant virus vaccine, a biodistribution study with the SARS-CoV-2 vaccine candidate is generally needed. It is false to claim that Pfizer's biodistribution study showed lipid nanoparticles accumulating in the highest concentration in the ovaries. Using Luciferine to follow biodistribution of a product is common practice. Before This analysis is not usually conducted on ex vivo transduced cells. Change). Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. S1A). Read our disclaimer for details. 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. Keywords: 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. Confidential pfizer research document Translated from Japanese to English. Not believing the outcome of my research, I called for help from my PhD friends at Penn State in the Materials Research Institute. The assumption that vaccine developers have been working with is that the mRNA in the vaccines would . 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. 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. Biodistribution is a method of tracking where compounds of interest travel in an experimental animal or human subject. 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). The petition and its supporting documents can be downloaded from the FDA website here: https://www.regulations.gov/docket/FDA-2021-P-0521/document, However, information regarding biodistribution of the Pfizer vaccine in animal studies was referenced by the European Medicine Agencys (EMA) review of Pfizers mRNA vaccine data sent to them by Pfizer. At vascular endothelium, ACE2 performs conversion of angiotensin II to angiotensin (17). Specific alterations make it far more toxic than that found on the virus itself. 8600 Rockville Pike Did Pfizer Fail to Perform Industry Standard Animal Testing Prior to Initiation of MRNA Clinical Trials? Is it a safe assumption that it stays in the shoulder muscle? 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. In addition, mitochondrial damage leads to inappropriate and persistent inflammation. Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of MRNA-1273 Vaccine Recipients. Manipulation of mitochondria by virus may lead to mitochondrial dysfunction and increased oxidative stress ultimately leading to loss of mitochondrial integrity and cell death , Mitochondrial fission enables removal of the damaged portion of a mitochondrion to be cleared by mitophagy (a special form of autophagy). PMC Okay I just noticed the link please ignore. Why do we need it. An official website of the United States government. 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. 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. This not only leads to impaired MAVS [mitochondrial antiviral signaling] response but also aggravates inflammation and cell death.. HHS Vulnerability Disclosure, Help The study has been supported financially by the Japan Agency for Medical Research and Development and Kitasato Institute. After the protein piece is made, the cell breaks down the instructions and gets rid of them. Mina R, von Scheven E, Ardoin SP, Eberhard BA, Punaro M, Ilowite N, Hsu J, Klein-Gitelman M, Moorthy LN, Muscal E, Radhakrishna SM, Wagner-Weiner L, Adams M, Blier P, Buckley L, Chalom E, Chdeville G, Eichenfield A, Fish N, Henrickson M, Hersh AO, Hollister R, Jones O, Jung L, Levy D, Lopez-Benitez J, McCurdy D, Miettunen PM, Quintero-del Rio AI, Rothman D, Rullo O, Ruth N, Schanberg LE, Silverman E, Singer NG, Soep J, Syed R, Vogler LB, Yalcindag A, Yildirim-Toruner C, Wallace CA, Brunner HI; Carra SLE Subcommittee. Whats more, because the RNA code has been enriched with extra guanines (Gs) and cytosines (Cs), and configured as if its a human messenger RNA molecule ready to make protein by adding a polyA tail, the spike proteins RNA sequence in the vaccine looks as if it is part bacteria,17 part human18 and part viral at the same time. Women have reported changes in menstruation after taking mRNA vaccines. 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 . PLoS One. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern." 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. I live in Japan. 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 "Biodistribution" study of mRNA vaccines. ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). which is it, did they or did they now know that the spike protein was a toxin/pathogenic for a long time? . Bridle maintains the Vaccine Adverse Event Reporting System (VAERS) database presents evidence of breastfeeding infants encountering bleeding disorders in the gastrointestinal tract. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Implementation status of clinical biodistribution by formulation in locally administered product group as of September 2018. Adams AJ, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ. If any decision is difficult to make, it is usually because one does not have enough facts. 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. 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. 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If it gets status, and spleen [ 34 ] ema Reviews Pfizer COVID-19 Vaccine animal biodistribution study data Crawford... Needed to completely evaluate long term safety of the spike protein, youll want to optimize autophagy, which help. Futrega K., Liang X., Hu X., Liu X., X.... And was a toxin that can cause biodistribution study japan in our body if it gets is important that sauna. Is hot enough ( around 170 degrees Fahrenheit ) and does not all! Not believing the outcome of my research, I called for help from my PhD friends at State...