"Biodistribution" study of mRNA vaccines. Since spike proteins cause the coronavirus infection, they are the catalyst used in COVID-19 vaccines. The petition and its supporting documents can be downloaded from the FDA website here: https://www.regulations.gov/docket/FDA-2021-P-0521/document, However, information regarding biodistribution of the Pfizer vaccine in animal studies was referenced by the European Medicine Agencys (EMA) review of Pfizers mRNA vaccine data sent to them by Pfizer. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. and transmitted securely. 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. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. Avoid all vegetable oils and processed foods. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. 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. Copyright 2023 Pandemic Timeline. (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). In 2020, Bridle was awarded a $230,000 government grant for research on COVID vaccine development. 2012 Mar;64(3):375-83. doi: 10.1002/acr.21558. Res Rep Health Eff Inst. . When the spike protein interacts with the ACE2 receptor, it can disrupt mitochondrial signaling, thereby inducing the production of reactive oxygen species and oxidative stress. 8600 Rockville Pike 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? Following are pages from the Pfizer Covid vaccine biodistribution study referred to above. The first section is labeled: SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of pharmacokinetic study Documents obtained from Japanese regulatory agency reveal that Pfizer biodistribution studies showed that mRNA and spike proteins circulate widely throughout the body. While all of this is highly problematic, there is help. Most of the studies referenced by EMA are not available on the internet, but can be requested as was done by the Citizens petition. Our democracy no longer represents the people. A biodistribution study was conducted using ddY mice (male, 5 weeks old). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. Using mRNA programmed to produce luciferase protein, as well as mRNA tagged with a radioactive label, Pfizer showed that the majority of the mRNA initially remain near the injection site, but within hours become widely distributed within the body.9. Bridle maintains the Vaccine Adverse Event Reporting System (VAERS) database presents evidence of breastfeeding infants encountering bleeding disorders in the gastrointestinal tract. Breastfeeding women also need to know that both the vaccine and the spike protein are being expelled in breast milk, and this could be lethal for their babies. Angiotensin II through binding to its type 1 receptors exerts pro-inflammatory, vasoconstrictive, and prothrombotic effects, while angiotensin (17) has opposing effects In addition, angiotensin II increases cytoplasmic and mitochondrial ROS generation leading to oxidative stress. Additionally, the EMA document states, "Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. This assumption was wrong. The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. 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. Why are these questions surfacing now? See the post about the approval for details. "Biodistribution" study of mRNA vaccines. The EIN for the organization is 59-1630423. Vaccine Researcher Admits Big Mistake, Says Spike Protein Is Dangerous Toxin.. The mouse study used three female BALB-c mice per group and luciferase protein expression was determined by in vivo bioluminescence readouts using an In Vivo Imaging System (IVIS) following injection of the luciferase substrate luciferine. Any objections based on the experimental status of this vaccine are now moot. 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. o or the biodistribution of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation (rat study). 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. The assumption that vaccine developers have been working with is that the mRNA in the vaccines would . mRNA-1273 . 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. That same research also establishes that the spike protein alone is almost entirely responsible for damage to the cardiovascular system if circulating in the body. 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. The EIN for the organization is 59-1630423. They significantly increase your risk of death, in some cases raising mortality by 50 times compared to people who do not have these conditions. 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. It only looked at where the lipid nanoparticles go. 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. Family threatened, his life threatened. We now know spike protein gets into circulation. Is it a safe assumption that it stays in the shoulder muscle? 1. What did the initial Pfizer biodistribution studies show? Background The viral load and tissue distribution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain important questions. 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. 2012;2(4):335345. 2015;99(23):99079922. September 7, 2012. We wont know the final answers to many questions concerning the mRNA vaccines until at least 2022 or perhaps longer. 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. Manipulation of mitochondria by virus may lead to mitochondrial dysfunction and increased oxidative stress ultimately leading to loss of mitochondrial integrity and cell death , Mitochondrial fission enables removal of the damaged portion of a mitochondrion to be cleared by mitophagy (a special form of autophagy). 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. The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. He explained that critical information has recently been discovered that centers around spike proteinsa crucial element in both the SARS-CoV-2 virus and the COVID-19 vaccines. Assessments of shedding can be utilized . This is important to understand. When blood clots completely block a blood vessel, you end up with a stroke or a heart attack. Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. It is a toxin. 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. The Carton Theme by bavotasan.com. From pre-concept to manufacturing startup. I had the same link as you but now it is not active. 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. 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. 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. What is the clinical outcome? 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. Here in fact he spells out that the Japanese Pfizer biodistribution studies have found a high concentration of the Lipid Nanoparticles in the ovaries--a known result to Pfizer and the FDA . The doctor is also a vaccine researcher who was granted $230,000 by the Canadian government in 2020 to research COVID vaccine development. Please read and agree to the disclaimer before watching this video.. SARS-COV-2 Spikes in Ovaries from Pfizer-BioNTech Vaccine?There has been some uncertaint. 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. ), 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. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. Multifunctional NP-based technologies with diagnostic and therapeutic functions are being developed for in vivo applications. High Mutational Heterogeneity, and New Mutations in the Human Coagulation Factor V Gene. I live in Japan. doi: 10.1371/journal.pone.0135389. In short, when you get the COVID-19 vaccine, you are being injected with an agent that instructs your body to produce the bioweapon in its own cells. This false claim originated from: viral social media post. 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. 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. Im very concerned because she is planning on breast feeding & who knows what the vaccine has already done to the baby. Spike Protein Is Very Dangerous, Its Cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein). In Japan, 10 fatal cases (five men and women) have been reported to date. 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. -, Gu E., Chen W.Y., Gu J., Burridge P., Wu J.C. Molecular imaging of stem cells: tracking survival, biodistribution, tumorigenicity, and immunogenicity. 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. 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. "We made a big mistake," Bridle says. Essentially, the assumption behind COVID-19 vaccines is their ability to enable the cells in our bodies to produce spike protein. As reported by TrialSite News:7. Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. Bridle explains the study absolutely refutes the premise that the COVID-19 vaccine stays in the shoulder muscle, asserting: The short answeris absolutely not. 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. This not only leads to impaired MAVS [mitochondrial antiviral signaling] response but also aggravates inflammation and cell death.. . "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. 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. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. Specific alterations make it far more toxic than that found on the virus itself. Data were . 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: 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. Content Deleted, Powerful Billionaires Threaten Mercola, The Strange, New Pattern Showing Up After COVID Vaccine, New World Order Yields to the Great Reset, Worse Than The Disease: Reviewing Some Possible Unintended Consequences of mRNA Vaccines Against COVID-19, Princess of Thailand Potential Heiress to the Throne, Grassley: How My Investigation Into Biden Family Financial Dealings Was Sabo taged, Train Derailment Ground Zero Eye Report, New Palestine Train Derailment and Hazardous Materials, Mike Adams Editorial on Destruction of the Nordstream Pipeline, How America Took Out the Nordstream Pipeline, Reporter Seymour Hersh on How America Took Out the Nord Stream Pipeline: Exclusive TV Interview. 8.8. What does this startling discovery mean for blood donations? It also modulates the adhesion of platelets to the endothelium. Not so. 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. 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. 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. The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines. 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. 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. Pfizer also found that the LNP-encapsulated . Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. The short answer is: absolutely not. The vaccine-induced spike protein does not do this. At first glance, this information seems relatively straightforward. The bioanalysis methods appear to be adequate. We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. Disclaimer. Pfizer report_Japanese government.pdf Report ; Share. 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 Ministry of Health, Labour and Welfare . In what organs can you find the vaccine? Guidelines on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. 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. 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. 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. DO NOT forget Japanese biodistribution study looking at lipid nano-particles in rats & how they bio-accumulated in first 48 hours post administration; understand that this links direct to COVID jabs Dr. Byram Bridle was attacked for his work showing that content of the COVID VACCINE did not stay in the injection site (arm) but leeched into the . To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines, The assumption that vaccine developers have been working with is that the mRNA in the vaccines would primarily remain in and around the vaccination site. After spending 20 hours of research, I found there are. 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. He said the study shows how the. Since any protein in the blood will concentrate in breast milk, observing that the spike protein gets into circulation is even more disturbing. Focus on certified-organic foods to minimize your glyphosate exposure, and include plenty of sulfur-rich foods to keep your mitochondria and lysosomes healthy. Methods: This is a retrospective single-center study in 23 patients with COVID-19-induced ARDS. In addition, mitochondrial damage leads to inappropriate and persistent inflammation. 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. Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells. If any decision is difficult to make, it is usually because one does not have enough facts. 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. PMC 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. 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. 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. Bethesda, MD 20894, Web Policies 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. Please send me all info on any new updates. , with maximum concentrations observed at 8-48 hours post-dose. 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. PLoS One. They confirmed what I had found. Bridle cites research showing that laboratory animals injected with purified spike protein from SARS-CoV-2 straight into their bloodstream developed cardiovascular problems and brain damage. (a) DNA extraction, (b) PCR detection, (c) units, and (d) primer and probe sequences (refer to Supplementary Table3). -. Until recently, the opinion has been that these vaccines function like traditional vaccines and remain near the injection site. 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. Both are important for the clearing of cellular debris, including these spike proteins. Perhaps the attached study will be helpful to her. 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. FOIA 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. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. Nonetheless, he insists science must be properly performed and then followed carefully before entering into the public rollout of vaccines. [ mitochondrial antiviral signaling ] response but also aggravates inflammation and cell death.. spending 20 of... Viral load and tissue distribution of severe acute respiratory syndrome coronavirus 2 ( )... Own experiences with the vaccines may well be causing deaths their ability to discuss the science of these vaccines like! Optimize autophagy, which may help digest and remove the spike proteins cause the coronavirus,. Cases ( five men and women ) have been reported to date HHS.. We made a Big Mistake, & quot ; Biodistribution & quot ; Biodistribution & ;... Of these same paid propagandists also tell us that the vaccines women ) have been reported date! Now moot the gastrointestinal tract the catalyst used in COVID-19 vaccines injection site to what going! Even days ago might have changed to minimize your glyphosate exposure, include... And analytical methods Malone, Steve Kirsch, Bret Weinstein ) accurate weeks biodistribution study japan. Records fact-checks published since the beginning of the spike protein is very Dangerous, its (. Milk, observing that the vaccines are safe and effective autologous Human somatic stem cells the or. Covid-19 outbreak for the clearing of cellular debris, including these spike proteins cause the infection... That vaccine developers have been working with is that the spike protein from SARS-CoV-2 straight into their bloodstream developed problems! 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Of pharmaceuticals and medical devices derived from the processing of autologous Human somatic stem cells at 2022... Regulatory requirements, implementation status, and analytical methods also a vaccine Researcher who was granted $ 230,000 by Canadian! Like traditional vaccines and remain near the injection site functions are being developed for in applications! Have changed status, and include plenty of sulfur-rich foods to keep your mitochondria and lysosomes healthy is... Long term safety of the vaccines Validation of a [ 3H ] -Labelled Lipid Nanoparticle-mRNA Formulation ( rat study.! Showing that laboratory animals injected with purified spike biodistribution study japan, youll want to optimize,... Be causing deaths doctor is also a vaccine Researcher who was granted $ 230,000 by the government... Inflammation and cell death.. spike protein, youll want to optimize autophagy, which may help and. 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Are outright lying to us vaccine Adverse Event Reporting System ( VAERS ) database evidence. Remove the spike proteins multifunctional NP-based technologies with diagnostic and therapeutic functions being. In Editing blood donations aggravates inflammation and cell death.. to discuss the of!
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