biodistribution study 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 Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. 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. 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 administered, COVID-19 vaccines are injected into the shoulder musclenot into the blood. 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. 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. Vitamin D Part I: Is Vitamin D really a vitamin? No published research data on biodistribution of the mRNA vaccines in animals can be found on the internet. eCollection 2015. ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). Pingback: Lying to children - Change is Always Possible. This false claim originated from: viral social media post. Pfizer report_Japanese government.pdf Report ; Share. For an LNP-mRNA vaccine, DNA vaccine, or recombinant virus vaccine, a biodistribution study with the SARS-CoV-2 vaccine candidate is generally needed. 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. Focus on certified-organic foods to minimize your glyphosate exposure, and include plenty of sulfur-rich foods to keep your mitochondria and lysosomes healthy. Change), You are commenting using your Facebook account. Sunlight also has other benefits besides making vitamin D. Use time-restricted eating and eat all your meals for the day within a six- to eight-hour window. Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D. 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. Pfizers data, however, show the mRNA and subsequent spike protein are widely distributed in the body within hours, This is a serious problem, as the spike protein is a toxin shown to cause cardiovascular and neurological damage. 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. Nanoparticles with positively charged surfaces tend to accumulate in the liver, lung, and spleen [ 34 ]. Accessibility in Japan for DNA vaccines and recombinant virus vaccines, or prior to the initiation of a large-scale clinical trial in Japan for LNP-mRNA vaccines. Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. 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. In related news, Dr. Malcolm Kendrick posted an article11 on his website June 3, 2021, in which he discusses the links between the SARS-CoV-2 spike protein and vasculitis, a medical term referring to inflammation (itis) in your vascular system, which is made up of your heart and blood vessels. Our democracy no longer represents the people. 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. Remember to check the date when the fact-check you are reading was published before sharing it. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. They significantly increase your risk of death, in some cases raising mortality by 50 times compared to people who do not have these conditions. 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. and when exactly? According to Kendrick, all of them have two things in common:12. . Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. Total recovery (% of injected dose) of radiolabeled LNP+modRNA outside the injection site was greatest in the liver (up to 21.5%) and was much less in spleen (1.1%), adrenal glands (0.1%) and ovaries (0.1%). Image . Stop using our children as shields in this battle that is an adult battle.. He said the study shows how the. Bridle explains the study absolutely refutes the premise that the COVID-19 vaccine stays in the shoulder muscle, asserting: The short answeris absolutely not. When an immune response is launched against the spike protein, the virus stops infecting the body. No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2. We thought the spike protein was a great target antigen; we never knew it was a toxin. In Japan, 10 fatal cases (five men and women) have been reported to date. The Japanese biodistribution study results are consistent with Pfizer's that was submitted to the European Medicines Agency (EMA) in February 2021. Consensus treatment plans for induction therapy of newly diagnosed proliferative lupus nephritis in juvenile systemic lupus erythematosus. Pingback: Vaccine Shedding: The Harm for Those Who Choose NOT to be Vaccinated - The Hollywood Conservative, Pingback: Vaccine Shedding: The Harm For Those Who Choose NOT To Be Vaccinated - TruthMatters.biz, Pingback: Breaking News Round Up Continues As The Old Traditional Rite Mass & Sacraments Become Restricted By Pope Francis | Traditional Catholics Emerge, Pingback: A Secular Perspective on Gods Judgment Anonymous, 7/30/21 | pomegranatesandchains, Pingback: LA School District Mandates COVID Jabs for All Students 12 and Older - Vaccine Effects. In the same way, its quite possible COVID-19 vaccines may promote Parkinsons and other human prion diseases such as Alzheimers. You can also boost your sulfate by taking Epsom salt baths. At first glance, this information seems relatively straightforward. Explanation: When you receive the covid vaccine, it will not impair the function of your ovaries, just as the coronavirus will not. There are many different types of vasculitis, including Kawasakis disease, antiphospholipid syndrome, rheumatoid arthritis, scleroderma and Sjogrens disease. The .gov means its official. This is important to understand. For example, in the development of new compounds for PET ( positron emission tomography) scanning, a radioactive isotope is chemically joined with a peptide (subunit of a protein ). After spending 20 hours of research, I found there are. Stem Cells Transl Med. Low levels of radioactivity were detected in most tissues, with the greatest levels in plasma observed 1-4 hours post-dose. 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. 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). 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. The liver received the highest dose (0.360 mSv/MBq), followed by the gallbladder wall (0.155 mSv/MBq). Next, LPP formulated with mRNA encoding luciferase as a model. Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. Elaborating on the implications of these findings, he remarked: We have known for a long time that the spike protein is a pathogenic protein. We made a big mistake, Bridle says. Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations. 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. 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. 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. The liver expression is also supportive of the data from the rat PK study and the findings in the rat repeat-dose toxicological study showing reversible liver vacuolation and increased GGT levels. In particular, a Japanese biodistribution study of Pfizers Covid-19 vaccine surfaced on the internet inferring the vaccine was highly distributed in the ovaries potentially causing infertility. The results in this review will be a useful resource for implementing BD studies. Bridle believes there should be more reliable evidence before vaccinating kids, and doctors from Johns Hopkins and the University of California San Francisco agree. It only means the studies are not available on an internet search. The short answer is: absolutely not. I had the same link as you but now it is not active. 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. What is the clinical outcome? Perhaps the attached study will be helpful to her. 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. Unauthorized use of these marks is strictly prohibited. In a separate study, mice received IV injection of an imaging dose of [ 52 Mn]MnCl 2, followed by in vivo imaging by positron emission tomography (PET) and ex vivo biodistribution. Women have reported changes in menstruation after taking mRNA vaccines. 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. Shedding is the dissemination of the viral vectors (e.g. Learn more 208-391-4000 Concise review: quantitative detection and modeling the in vivo kinetics of therapeutic mesenchymal stem/stromal cells. For Vaxzevria, a single-dose intramuscular biodistribution study with AZD1222 in mice (study 514559) was submitted post-authorisation. 2020 Jun 1;18:176-188. doi: 10.1016/j.omtm.2020.05.029. Together with international scientists, he requested access to the "biodistribution study" from the Japanese regulatory agency that is labeled "Pfizer Confidential." The objective of this guideline is to provide harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products. 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. Proves the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver,. Confidential pfizer research document Translated from Japanese to English. Your body for some reason starts to attack the lining of your blood vessels, thereby causing damage and inflammation The why can differ from one case to another, but in all cases, your immune system identifies something foreign in the lining of the blood vessel, causing it to attack. The research examined thirteen young healthcare workers who had received the Moderna vaccine. Time-restricted eating will upregulate autophagy, while sauna therapy, which upregulates heat shock proteins, will help refold misfolded proteins and also tag damaged proteins and target them for removal. Using Luciferine to follow biodistribution of a product is common practice. As such, it seemed really risky to instruct the bodys cells to produce the very thing that causes severe problems. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. The study is titled, "Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel-group comparison . The doctor is also a vaccine researcher who was granted $230,000 by the Canadian government in 2020 to research COVID vaccine development. 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. In vivo luciferase expression was detected at different timepoints at the injection sites and in the liver region indicating drainage to the liver. 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. Instead it stays open and remains attached to the ACE2 receptor, thereby disabling it and causing a host of problems that lead to heart, lung and immune impairment. Why are these questions surfacing now? The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines. Anyway, the answer to this question unfortunately is that they go pretty much everywhere. Did Pfizer Fail to Perform Industry Standard Animal Testing Prior to Initiation of MRNA Clinical Trials? -, Brooks A., Futrega K., Liang X., Hu X., Liu X., Crawford D.H.G. Since spike proteins cause the coronavirus infection, they are the catalyst used in COVID-19 vaccines. Im the same I would like to find the original paper in Japanese if possible. Before Their data clearly showed that the injection site retained the largest concentration of these nanoparticles, but the article omitted this fact. It was a pre-clinical biodistribution study. 3 Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan. As we reported last June 14, Bridle received a copy of a Japanese biodistribution study, which had been withheld from the public, as a result of a freedom of information request made to the Japanese government for data from Pfizer. Messenger RNA (mRNA) vaccines for coronavirus disease 2019 (COVID-19) have been widely deployed in the United States and are highly effective at inducing protection against infection and severe disease [].In December 2020, the Food and Drug Administration gave emergency use authorization (EUA) to the mRNA-1273 vaccine (ModernaTX, Inc), as a two 100-g dose regimen 28 days apart. Appl Microbiol Biotechnol. In what organs can you find the vaccine? 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. 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. Multifunctional NP-based technologies with diagnostic and therapeutic functions are being developed for in vivo applications. In the case of covid-19 vaccines, regulators accepted biodistribution data from past studies performed with related, mostly unapproved compounds that use the same platform technology. Bethesda, MD 20894, Web Policies See the post about the approval for details. Fact Sheet for Healthcare Providers Administering Vaccine [Pfizer-BioNTech]. You are not transferring antibodies. 22 23 24 25 Janssen told The BMJ its covid-19 vaccine leverages the same technology as its Ebola vaccine, which received licensure last June. Copyright 2023 Pandemic Timeline. 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. 2012;2(4):335345. , with maximum concentrations observed at 8-48 hours post-dose. According to Bridle, the discovery also has implications for breastfeeding infants and severe consequences for people for whom the SARS-CoV-2 virus is not a high-risk pathogen, including all children. Remember, the research cited by Bridle at the beginning of this article found the spike protein accumulates in the spleen, among other places. Change), You are commenting using your Twitter account. Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. 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. *, o LNP=LipoNanoParticle which carries the mRNA, o LC-MS/MS is liquid chromatography with tandem mass spectrometry. 2021 The Japanese Society for Regenerative Medicine. This information is found on the internet leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer. government site. 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. In fragile patients receiving the blood, the damage could be lethal. So by vaccinating people, we are inadvertently inoculating them with a toxin.. Adams AJ, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. 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. 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. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. 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. When in circulation, the spike protein can bind to the receptors that are on our platelets and the cells that line our blood vessels. The Ministry of Health, Labour and Welfare . Keywords: Our toxicology study showed a benign safety profile with just the expected inflammation associated with an immune response to the vaccine. Unable to load your collection due to an error, Unable to load your delegates due to an error. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. 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.