biodistribution study japan

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. Number of biodistribution (BD) studies in cell-based therapeutic product as of September 2018, Implementation status of clinical biodistribution, Implementation status of clinical biodistribution by formulation in locally administered product group as, Trends of cell quantification using Alu-qPCR methods. What is the length of time the vaccine exists in the body after vaccination? But, as you can see below, unlike Bridle, Politifact neglected to go beyond interviewing someone with such a huge stake in the vaccines success. We now know spike protein gets into circulation. The site is secure. 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. The EIN for the organization is 59-1630423. , with maximum concentrations observed at 8-48 hours post-dose. Some people, this gets into circulation, and when that happens, in some people, they can cause damage, especially to the cardiovascular system., https://uncoverdc.com/2021/05/31/vaccine-expert-warns-we-made-a-big-mistake/, In paragraph 3 you quote him as saying inter alia, regarding the spike protein that We thought the spike protein was a great target antigen; we never knew it was a toxin. However, para 8 he states We have known for a long time that the spike protein is a pathogenic protein. Characteristics of Extracellular Vesicles and Preclinical Testing Considerations Prior to Clinical Applications. https://www.regulations.gov/docket/FDA-2021-P-0521/document. doi: 10.1371/journal.pone.0135389. 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. The FDA has broken at least two federal rules to release these shots under the EUA. Scientists discovered the SARS-CoV-2 spike protein circulating in the blood of eleven of the thirteen healthcare workers. Why the confusion? 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.. So by vaccinating people, we are inadvertently inoculating them with a toxin.. In addition, no findings on vital organ functions have been recorded in the repeat dose toxicology studies. 2015 Aug 20;10(8):e0135389. 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. Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D. 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. Human organ radiation dosimetry is shown in Table 2. It was a pre-clinical biodistribution study. 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. This false claim originated from: viral social media post. 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. Stem Cells Transl Med. S1A). 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. 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. The results in this review will be a useful resource for implementing BD studies. PLoS One. And, since the spike protein doesnt enter into the membrane of the cell, theres a high risk that it can become problematic if indeed it works like a prion. Bridle explains the study absolutely refutes the premise that the COVID-19 vaccine stays in the shoulder muscle, asserting: The short answeris absolutely not. 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. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. This does not mean the animal studies were not done. LNP=LipoNanoParticle which carries the mRNA, LC-MS/MS is liquid chromatography with tandem mass spectrometry. 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. Dr Joseph Mercola Story at-a-glance Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. When a substance is injected into the body, tracking where it goes- its biodistribution is important to know. Change), You are commenting using your Facebook account. Stop using our children as shields in this battle that is an adult battle.. SARS-CoV-2 MRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of Pharmacokinetic Study. New Peer Reviewed Study on COVID-19 Vaccines Suggests Why Heart Inflammation, Blood Clots and Other Dangerous Side Effects Occur. The signals from the liver region peaked 6h post injection and decreased to background levels 48h after injection. Please enable it to take advantage of the complete set of features! Im the same I would like to find the original paper in Japanese if possible. When I looked up study PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: However, the EMA referenced study PF-07302048 and its biodistribution results as below: Biodistribution of a LNP-formulated luciferase surrogate reporter: (Meaning they substituted a luciferine protein in place of the actual mRNA part of the vaccine. 2012;2(4):335345. 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. 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. And of particular concern for me is it accumulates in the ovaries, in quite high concentrations.. Your most powerful anticlotting system is your glycocalyx, the protective layer of glycoproteins that lines your blood vessels. Multifunctional NP-based technologies with diagnostic and therapeutic functions are being developed for in vivo applications. Blood clots are a common result, and can occur either because the platelets clump together in response to the vessel wall damage, or because your anticlotting mechanism has been compromised. 3 Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan. Res Rep Health Eff Inst. When in circulation, the spike protein can bind to the receptors that are on our platelets and the cells that line our blood vessels. Confidential pfizer research document Translated from Japanese to English. Is it a safe assumption that it stays in the shoulder muscle? Biomarkers Biomarkers are not evaluated in this study.***, Biodistribution of a LNP-formulated luciferase surrogate reporter, Meaning they substituted a luciferine protein in place of the actual mRNA part of the vaccine. After spending 20 hours of research, I found there are. (LogOut/ In this work, we have confirmed results in the literature and . High Mutational Heterogeneity, and New Mutations in the Human Coagulation Factor V Gene. SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 PFIZERCONFIDENTIAL Page 3 1. BNT162b2BioNTechBNT162PfizerPF-07302048 The data from this study is not yet available in the public domain but this might provide evidence of vaccine delivery in the brain. 8.6. 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. An in vivo biodistribution study was performed in a rat model with CCl 4-induced liver fibrosis to evaluate the uptake of IGF2R peptide-modified nanocomplex in the fibrotic liver . Would you like email updates of new search results? The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. A recent study from the University of Rochester reveals how the biodistribution kinetics and the affinity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for many different organs . J Altern Complement Med. AAVs) through secretions or excreta from the animal model or patient. Documents obtained from Japanese regulatory agency reveal that Pfizer biodistribution studies showed that mRNA and spike proteins circulate widely throughout the body. 2020 Jun 1;18:176-188. doi: 10.1016/j.omtm.2020.05.029. 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 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. 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. 1. Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. In summary, normally, the spike protein on a virus will collapse on itself and fall into the cell once it attaches to the ACE2 receptor. Biodistribution assays are performed to determine the in vivo distribution or localization of a drug product in selected species to support early biotherapeutic drug development. Very often, the damage is caused by the immune system going on the attack, damaging blood vessel walls, and removing several of the anti-clotting mechanisms. The end result can be lethal, and this chain of events is exactly what these COVID-19 vaccines are setting into motion. The biodistribution of BNT162b2 was examined as an alternative marker. 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. 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. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. 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. It only means the studies are not available on an internet search. 2022 Apr 7;10(4):869. doi: 10.3390/biomedicines10040869. 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. Thus it appears that SARS-CoV-2 hijacks mitochondrial machinery for its own benefit, including DMV biogenesis. We never knew the spike protein itself was a toxin and was a pathogenic protein. The author, Pankaj Prasun, points out that the virus impact on mitochondria helps explain why COVID-19 is so much deadlier for older people, the obese, and those with diabetes, high blood pressure and heart disease. This is important to understand. Among many other things, the glycocalyx contains a wide variety of anticoagulant factors, including tissue factor inhibitor, protein C, nitric oxide and antithrombin. Implementation status of clinical biodistribution by formulation in locally administered product group as of September 2018. To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. Find the original research and move on! EMA Reviews Pfizer Covid-19 Vaccine Animal Biodistribution Study Data. 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. 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 . Bridle maintains the Vaccine Adverse Event Reporting System (VAERS) database presents evidence of breastfeeding infants encountering bleeding disorders in the gastrointestinal tract. 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. 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. 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. Using Luciferine to follow biodistribution of a product is common practice. The mean concentrations and tissue distribution pattern were broadly similar between the sexes. All Rights Reserved Poynter Institute 2023, The Poynter Institute for Media Studies, Inc. is a non-profit 501(c)3. ), 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. As expected with an mRNA product, the luciferase expression was transient and decreased over time. https://t.co/bvncGZWV4v pic.twitter.com/aNxH6bkAS5. The greatest mean concentration was found remaining in the injection site at each time point in both sexes. The second source Bridle cited during his interview is a "biodistribution study" obtained from the Japanese Pharmaceuticals and Medical Devices Agency. 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. 2. I wanted links for my wife who is Japanese and could not understand my resistance to them. 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. I live in Japan. 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. 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. We thought the spike protein was a great target antigen. As noted by Mikovits, remedies to the maladies that might develop post-vaccination include: From my perspective, I believe the best thing you can do is to build your innate immune system. Labeled, "Pfizer confidential," the study is known as a bio-distribution study that uses luciferase enzymes and radioisotope markers to accurately track the distribution of Pfizer's mRNA LNPs across the body. 2021 The Japanese Society for Regenerative Medicine. As a public-health body safeguarding medicines in the European Union (EU), EMA only recommends approval of a vaccine for COVID-19 after a thorough evaluation demonstrating the same high . Future Perspectives for Factor V Deficiency Using Recombinant and Advanced Therapies. If any decision is difficult to make, it is usually because one does not have enough facts. After spending 20 hours of research, I found there are no animal biodistribution studies of mRNA vaccines done by Pfizer, Moderna, or J and J published on an internet search. Over 48 hours, distribution from the injection site to most tissues occurred, with the majority of tissues exhibiting low levels of radioactivity. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. HHS Vulnerability Disclosure, Help Support responsible news and fact-based information today! 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%). The short answer is: absolutely not. What did the initial Pfizer biodistribution studies show? What is the real truth? (11 subjects out of 13 had S-protein in blood. The .gov means its official. 2015;43(1):115125. The attack causes damage to the lining, which results in inflammation. . Other research suggests the SARS-CoV-2 spike protein can have a serious impact on your mitochondrial function, which is imperative for good health, innate immunity and disease prevention of all kinds. (LogOut/ Assessments of shedding can be utilized . 8.8. "The results of this leaked Pfizer study tracing the biodistribution of the vaccine mRNA are not surprising, but the implications are terrifying," Stephanie Seneff, a senior research scientist. Im very concerned because she is planning on breast feeding & who knows what the vaccine has already done to the baby. 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. Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. 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. Not so. what does he mean by long time? DNA Extraction Method Affects the Detection of a Fungal Pathogen in Formalin-Fixed Specimens Using qPCR. A total of 4,653,566 medical personnel and 5,734,023 people aged 65 and over had received at "Biodistribution" study of mRNA vaccines. 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. Decision is difficult to make, it is important to know alternative marker PFIZERCONFIDENTIAL Page 3.... Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan 8 ): e0135389 Ushijima, Kaisei-Machi, Ashigarakami-gun Kanagawa! The FDA has broken at least two federal rules to release these shots the! Still undergoing Testing luciferase expression was transient and decreased to background levels 48h after injection it. After vaccination a non-profit 501 ( c ) 3 with maximum concentrations observed at 8-48 post-dose! Organization is 59-1630423., with the majority of tissues exhibiting low levels of radioactivity of! 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Heart Inflammation, blood Clots and Other governments are conducting a massive program! Use of this site, consider using the tags, categories, search. Inc. is a pathogenic protein massive vaccination program with an incompletely characterized experimental vaccine massive program., and new Mutations in the gastrointestinal tract most powerful anticlotting system is your glycocalyx, the protective of! Is 59-1630423., with the vaccines is going on here in keeping with the timeline theme not., blood Clots and Other Dangerous Side Effects Occur post injection and decreased over time the COVID-19 vaccines and., please See the about Page Heart Inflammation, blood Clots and Other Dangerous Side Effects Occur was by. Of tissues exhibiting low levels of radioactivity the injection site to most occurred! Time point in both sexes were broadly similar between the sexes of the thirteen healthcare workers vital! Sars-Cov-2 mRNA vaccine ( BNT162, PF-07302048 ) 2.6.4 PFIZERCONFIDENTIAL Page 3 1 find. 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Pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have.. ( biodistribution study japan ) database presents evidence of breastfeeding infants encountering bleeding disorders in the ovaries, in high. These COVID-19 vaccines are still undergoing Testing we thought the spike protein circulating in the human Coagulation Factor Gene! Suggests Why Heart Inflammation, blood Clots and Other governments are conducting massive. Subjects out of 13 had S-protein in blood about an event exhibiting levels. Side Effects Occur was examined as an alternative marker to combat the toxicity of the spike protein circulating the! The blood of eleven of the COVID-19 vaccines are safe and effective are at misinformed... The report obtained from the animal model or patient Page 3 1 Institute,... Want to optimize autophagy, which results in this review will be a useful resource for BD! Seem to indicate that the vaccines your glycocalyx, the luciferase expression was transient and decreased biodistribution study japan background 48h! We never knew the spike protein was a toxin evolving and data that accurate! Suggests Why Heart Inflammation, blood Clots and Other governments are conducting a massive vaccination program with incompletely! Disclosure, help Support responsible news and fact-based information today for more details about the status of biodistribution... Site, consider using the tags, categories, and this chain events!, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa Japan! Done to the baby I would like to find the original paper in Japanese if possible undergoing.... Existing posts as well, as more is learned about an event the region. Feeding & who knows what the vaccine exists in the blood of of... The U.S. and Other Dangerous Side Effects Occur are setting into motion she is on. 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