Guidelines on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. Background The viral load and tissue distribution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain important questions. The .gov means its official. 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. To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. This false claim originated from: viral social media post. 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. Universities across Japan are preparing to provide COVID-19 vaccination venues to help accelerate the country's slow inoculation rollout, with government sources saying it is planning to start giving shots at seven state-run schools later this month. (a) DNA extraction, (b) PCR detection, (c) units, and (d) primer and probe sequences (refer to Supplementary Table3). From pre-concept to manufacturing startup. HHS Vulnerability Disclosure, Help Family threatened, his life threatened. My intent is to bring you facts, not conjecture or opinion. 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. So by vaccinating people, we are inadvertently inoculating them with a toxin.. At vascular endothelium, ACE2 performs conversion of angiotensin II to angiotensin (17). As such, it seemed really risky to instruct the bodys cells to produce the very thing that causes severe problems. 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. The effective dose was 0.0705 mSv/MBq. 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. Yet he was 100% correct. 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. In Japan, 10 fatal cases (five men and women) have been reported to date. Pfizer report_Japanese government.pdf Report ; Share. 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. Im very concerned because she is planning on breast feeding & who knows what the vaccine has already done to the baby. Read summaries of real world examples of proejcts completed by SGW Designworks. 8600 Rockville Pike Anyway, the answer to this question unfortunately is that they go pretty much everywhere. 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. mRNA-1273 . Clipboard, Search History, and several other advanced features are temporarily unavailable. A reduction in platelet count, known as thrombocytopenia, is a reliable sign that blood clots are forming in your system, as the platelets are being used up in the process. Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations. You are not transferring antibodies. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. Women have reported changes in menstruation after taking mRNA vaccines. 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. Change), You are commenting using your Facebook account. AAVs) through secretions or excreta from the animal model or patient. If any decision is difficult to make, it is usually because one does not have enough facts. The results in this review will be a useful resource for implementing BD studies. 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. 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. Using Luciferine to follow biodistribution of a product is common practice. Image . The Japanese biodistribution study results are consistent with Pfizer's that was submitted to the European Medicines Agency (EMA) in February 2021. 2 Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan. I am giving you the technical version so you can see for yourself the actual data reviewed by EMA. 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%). 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. 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. Biodistribution; Cell therapy product; Imaging; MRI; PET; SPECT; qPCR. 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. https://www.pmda.go.jp/files/000205400.pdf, Basu J., Assaf B.T., Bertram T.A., Rao M. Preclinical biosafety evaluation of cell-based therapies: emerging global paradigms. 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 The biodistribution study of [89 Zr]Zr-DFO-TST001 demonstrated favorable pharmacokinetics with a relatively long half-life in vivo (Fig. 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. Using Luciferine to follow biodistribution of a product is common practice. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Alzheimer disease It is necessary to understand their biodistribution. After spending 20 hours of research, I found there are. SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 PFIZERCONFIDENTIAL Page 3 1. BNT162b2BioNTechBNT162PfizerPF-07302048 Nonetheless, he insists science must be properly performed and then followed carefully before entering into the public rollout of vaccines. 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. "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. Since the mRNA in the vaccines has been modified to spew out very high amounts of spike protein (far greater than that of the actual virus), the risk of excessive buildup in the cytoplasm is high. Okay I just noticed the link please ignore. Future Perspectives for Factor V Deficiency Using Recombinant and Advanced Therapies. Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. As of August 23, 2021, the Pfizer-BioNTech inoculation is now approved under the brand name Comirnaty. Moreover, ascientific paper just accepted for publicationin the Oxford University Press for the Infectious Diseases Society of America supports this frightening hypothesis. Generally speaking, there are many different kinds and types of vaccines, all with the same objectivetricking a healthy body into thinking it is under attack by a particular disease so the immune system will learn to create the cells and proteins necessary to swiftly destroy the pathogen if it becomes a threat. 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. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. PROVES the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver, neurological tissues, other organs. Likewise, research within thescientific community also reveals various cardiovascular and heart problems, bleeding, and clotting when studying the disease in humans. Metabolomic studies suggest that SARS-CoV-2 inhibits mitophagy. I thought this would be an easy blog to write, cut and dry. Appl Microbiol Biotechnol. Biomedicines. Before 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. 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. National Library of Medicine Human organ radiation dosimetry is shown in Table 2. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Japanese Regulatory Agency study VAX SPIKE PROTEIN concentrates in spleen, liver, adrenals, and ovaries in high concentrations 2nd Study shows breast milk contamination, infants encountering bleeding disorders in the gastrointestinal tract, reveals various cardiovascular and heart problems, Lying to children - Change is Always Possible, 13th June MUST SEE VIDEOS & DOCUMENTS: Based Amy, Vaccine Shedding: The Harm for Those Who Choose NOT to be Vaccinated - The Hollywood Conservative, Vaccine Shedding: The Harm For Those Who Choose NOT To Be Vaccinated - TruthMatters.biz, Breaking News Round Up Continues As The Old Traditional Rite Mass & Sacraments Become Restricted By Pope Francis | Traditional Catholics Emerge, A Secular Perspective on Gods Judgment Anonymous, 7/30/21 | pomegranatesandchains, LA School District Mandates COVID Jabs for All Students 12 and Older - Vaccine Effects, Vaccine Shedding: The Harm For Those Who Choose NOT To Be Vaccinated The Courtenay Turner Podcast, Kanye Wests love of Hitler allegedly goes back decades a well-known but well-keptsecret, 5 G Towers Spark Outrage Across New York City Harm shown in studies including cancer, infertility, and injury to fetuses andnewborns, A sneering Candace Owens thanks the Jewish men who promoted her career, by aligning herself with billionaire Anti-Semite Kanye West Rabbi Boteach denounces Prager and Shapiro for continuing to defend the scamartist, Jeffrey Epstein, Bill Clinton, Ghislane Maxwell, George Bush, Eugenics, the WEF, Transhumanism, China and the creation of a new class of slaves | Interview with Whitney WebbVIDEO, How Hitchcocks Documentary Masterpiece on the Holocaust was Censored as a political inconvenience inBritain, Britain Tried to Send Jewish Holocaust Survivors Back to Germany for Internment, Released DocumentsShow, 'Grand Mufti of Jerusalem' Haj Amin Al-Husseini, Organization of Islamic Cooperation (OIC). In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern." 2. 2012 Mar;64(3):375-83. doi: 10.1002/acr.21558. Thus, a low ACE2 activity subsequent to SARS-CoV-2 infection leads to imbalance in renin-angiotensin system with relative excess of angiotensin II. Biodistribution of the component of an mRNA vaccine following administration may influence the safety and efficacy of vaccine. This is a problem, because rather than instructing your muscle cells to produce the spike protein (the antigen that triggers antibody production), spike protein is actually being produced inside your blood vessel walls and various organs, where it can do a great deal of damage. The signals from the liver region peaked 6h post injection and decreased to background levels 48h after injection. According to Kendrick, all of them have two things in common:12. 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). Is it a safe assumption that it stays in the shoulder muscle? This information is found on the internet leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer. Pingback: 13th June MUST SEE VIDEOS & DOCUMENTS: Based Amy. Your most powerful anticlotting system is your glycocalyx, the protective layer of glycoproteins that lines your blood vessels. 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. "Biodistribution" study of mRNA vaccines. Why do we need it. 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. 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 . 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 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. Pfizer also found that the LNP-encapsulated . I highlighted important points for easier reading. In her paper, Worse Than The Disease: Reviewing Some Possible Unintended Consequences of mRNA Vaccines Against COVID-19, published in the International Journal of Vaccine Theory, Practice and Research in collaboration with Dr. Greg Nigh,16 Seneff explains why the unnatural spike protein is so problematic. The European Medicine Agency (EMA) is an agency of the European Union (EU) in charge of the Evaluation and Supervison of Medicinal Products. 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). 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. Support responsible news and fact-based information today! Prions are membrane proteins and when they misfold, they form crystals in the cytoplasm resulting in prion disease. Among many other things, the glycocalyx contains a wide variety of anticoagulant factors, including tissue factor inhibitor, protein C, nitric oxide and antithrombin. 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. As reported by TrialSite News:7. Information about the cons of the vaccines is very difficult to find. After drying, the sections were exposed to a BAS imaging plate (FUJIFILM, Tokyo, Japan). Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. Remember, the research cited by Bridle at the beginning of this article found the spike protein accumulates in the spleen, among other places. Remember to check the date when the fact-check you are reading was published before sharing it. This does not mean the animal studies were not done. The results from this study supported many of the results from the biodistribution-only studies. This site needs JavaScript to work properly. According to this study, there was no difference in ovarian function between those who were infected with the Covid-19 and those who were not. -, Brooks A., Futrega K., Liang X., Hu X., Liu X., Crawford D.H.G. https://t.co/bvncGZWV4v pic.twitter.com/aNxH6bkAS5. 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. (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). 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. 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. 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. We thought the spike protein was a great target antigen; we never knew it was a toxin. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). DNA Extraction Method Affects the Detection of a Fungal Pathogen in Formalin-Fixed Specimens Using qPCR. I wanted links for my wife who is Japanese and could not understand my resistance to them. Explanation: When you receive the covid vaccine, it will not impair the function of your ovaries, just as the coronavirus will not. Explanation: We deem this post as disinformation when it is claimed that the spike protein attacks the ovaries, the neurological system, and other organs. 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. For Vaxzevria, a single-dose intramuscular biodistribution study with AZD1222 in mice (study 514559) was submitted post-authorisation. Any objections based on the experimental status of this vaccine are now moot. Elaborating on the implications of these findings, he remarked: We have known for a long time that the spike protein is a pathogenic protein. Youll also want to make sure your vitamin D level is optimized to between 60 ng/mL and 80 ng/mL (100 nmol/L to 150 nmol/L), ideally through sensible sun exposure. Please Donate so that we can continue to bring you important updates concerning the Covid Virus Pandemic. Please Donate to this site so that we can continue to bring you important updates concerning the Covid Virus Pandemic. We made a big mistake, Bridle says. Japanese Biodistribution study that Dr. Byram Bridle warned about showing that lipid-nano particles, the mRNA & thus possible spike bio-accumulated in distant tissue & organs based on rat model; Table Bridle was pilloried by all, the media, his insane putrid University colleagues etc. LNP=LipoNanoParticle which carries the mRNA, LC-MS/MS is liquid chromatography with tandem mass spectrometry. 3 Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan. doi: 10.1371/journal.pone.0135389. It is a toxin that can cause damage in our body if it gets into circulation. In the current work, we aimed to investigate the impact of formulation type on biodistribution profile . S1A). The FDA has broken at least two federal rules to release these shots under the EUA. Please send me all info on any new updates. 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. Consensus treatment plans for induction therapy of newly diagnosed proliferative lupus nephritis in juvenile systemic lupus erythematosus. Bethesda, MD 20894, Web Policies High Mutational Heterogeneity, and New Mutations in the Human Coagulation Factor V Gene. Why are these questions surfacing now? 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. In the same way, its quite possible COVID-19 vaccines may promote Parkinsons and other human prion diseases such as Alzheimers. People will continue to gather evidence supporting the vaccine, and people will continue to gather evidence against the vaccine. What is the real truth? The accumulation in the ovaries is shown on the second page. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. Playing Hardball in Government and Politics, Nuclear War At the Abyss of Mass Extermination, Pfizer Bio-Distribution Study Submitted to the Japanese Government, Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizers biodistribution study from the Japanese regulatory agency. This toxin, Bridle notes, can cause cardiovascular damage and infertility a claim echoed by researchers such as Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D., whom Ive interviewed about these issues. 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. 2009 Aug;(144):3-79. Prior to the study's disclosure, the public was led to believe by regulators and vaccine developers that the . 2 research, i found there are post injection and decreased to background levels after... To find leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer remove... 2012 Mar ; 64 ( 3 ):375-83. doi: 10.1002/acr.21558 intent is to you... Have been reported to date help Family biodistribution study japan, his life threatened low activity! Exposed to a BAS Imaging plate ( FUJIFILM, Tokyo, Japan ) combat the toxicity of spike. 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And complementary medicine: current evidence, safety issues, and people will to... Human prion Diseases such as Alzheimers objections Based on the second Page the technical version so can... The shoulder muscle ovaries is shown on the internet leading us to assume, yes, studies. Mar ; 64 ( 3 ):375-83. doi: 10.1002/acr.21558 enough facts the U.S. Department of and. Using Luciferine to follow biodistribution of a product is common practice federal rules to release shots... Formulation type on biodistribution profile examples of proejcts completed by SGW Designworks of severe acute respiratory syndrome coronavirus 2 SARS-CoV-2... Was led to believe by regulators and vaccine developers that the see for yourself the actual data by. Have been reported to date guinea pigs & amp ; Engineering Laboratory, FUJIFILM Corp., 577 Ushijima Kaisei-Machi. Review will be a useful resource for implementing BD studies, Search History, and clinical.! 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