An official website of the United States government. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. The FDA has broken at least two federal rules to release these shots under the EUA. Stop using our children as shields in this battle that is an adult battle.. 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. Prior to the study's disclosure, the public was led to believe by regulators and vaccine developers that the . Since spike proteins cause the coronavirus infection, they are the catalyst used in COVID-19 vaccines. All Rights Reserved Poynter Institute 2023, The Poynter Institute for Media Studies, Inc. is a non-profit 501(c)3. Their data clearly showed that the injection site retained the largest concentration of these nanoparticles, but the article omitted this fact. 2015;43(1):115125. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. This analysis is not usually conducted on ex vivo transduced cells. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. 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. Once in your blood circulation, the spike protein binds to platelet receptors and the cells that line your blood vessels. In the current work, we aimed to investigate the impact of formulation type on biodistribution profile . 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. Nanoparticles with positively charged surfaces tend to accumulate in the liver, lung, and spleen [ 34 ]. It also has reproductive toxicity, and Pfizers biodistribution data show it accumulates in womens ovaries, Once in your blood circulation, the spike protein binds to platelet receptors and the cells that line your blood vessels. Not believing the outcome of my research, I called for help from my PhD friends at Penn State in the Materials Research Institute. Is there a translated version to English of the study somewhere we can access? 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. Biodistribution; Cell therapy product; Imaging; MRI; PET; SPECT; qPCR. 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. At first glance, this information seems relatively straightforward. It only looked at where the lipid nanoparticles go. The objective of this guideline is to provide harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products. You are not transferring antibodies. Messenger RNA (mRNA) vaccines for coronavirus disease 2019 (COVID-19) have been widely deployed in the United States and are highly effective at inducing protection against infection and severe disease [].In December 2020, the Food and Drug Administration gave emergency use authorization (EUA) to the mRNA-1273 vaccine (ModernaTX, Inc), as a two 100-g dose regimen 28 days apart. February 19, 2021, the EMA wrote the following assessment report on Pfizers Covid-19 mRNA vaccine BNT162b2. . 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. Okay I just noticed the link please ignore. The Carton Theme by bavotasan.com. Why the confusion? 1. 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. We never knew the spike protein itself was a toxin and was a pathogenic protein. 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. . 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. HHS Vulnerability Disclosure, Help government site. . SARS-CoV-2 MRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of Pharmacokinetic Study. Please Donate to this site so that we can continue to bring you important updates concerning the Covid Virus Pandemic. The spike protein also travel to your heart, brain and lungs, where bleeding and or blood clots can occur as a result, and is expelled in breast milk. As such, it seemed really risky to instruct the bodys cells to produce the very thing that causes severe problems. 2012;2(4):335345. Dysfunctional mitochondria predispose to oxidative stress and loss of cellular function and vitality. Information about the cons of the vaccines is very difficult to find. 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. 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. In my interview with Seneff and Mikovits (see earlier hyperlink), they both stressed that the key danger both in COVID-19 and with the vaccines is the spike protein itself. Number of biodistribution (BD) studies in cell-based therapeutic product as of September 2018 in comparison among (a) local or systemic administration product, (b) commercialized or product in clinical phases, (c) biodistribution measurement modalities, (d) clinical phases of development, (e) used animal species and (f) measurement modalities and biodistribution study duration (refer to Supplementary Table1). -, Gu E., Chen W.Y., Gu J., Burridge P., Wu J.C. Molecular imaging of stem cells: tracking survival, biodistribution, tumorigenicity, and immunogenicity. Tags:Japan Pfizer spike proteins vaccines. It also was featured in a fact check by The Poynter Institutes Politifact,2 which pronounced Bridles findings as false after interviewing Dr. Drew Weissman,3 a UPenn scientist who is credited with helping to create the technology that enables the COVID mRNA vaccines to work. Scientists discovered the SARS-CoV-2 spike protein circulating in the blood of eleven of the thirteen healthcare workers. 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. No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2. To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. All of these risk factors have something in common: Theyre all associated with mitochondrial dysfunction. Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. 12 . Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. In particular, a Japanese biodistribution study of Pfizer's Covid-19 vaccine surfaced on the internet inferring the vaccine was highly distributed in the ovaries potentially causing infertility. When that happens, it can do one of two things: it can either cause platelets to clump, and that can lead to clottingthats exactly why weve been seeing clotting disorders associated with these vaccines. See this image and copyright information in PMC. 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. 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. The European Medicine Agency (EMA) is an agency of the European Union (EU) in charge of the Evaluation and Supervison of Medicinal Products. What is the real truth? The .gov means its official. The results from this study supported many of the results from the biodistribution-only studies. As The Defender reported June 3, Bridle received a copy of a Japanese biodistribution study which had been kept from the public as a result of a freedom of information request made to the Japanese government for Pfizer data. 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. People are now receiving injections with an mRNA gene therapy-based vaccine, which produces the SARS-CoV-2 spike protein in their cells, and the vaccine may be also delivering the mRNA and producing spike protein in unintended organs and tissues (which may include ovaries)., The assumption that vaccine developers have been working with is that the mRNA in the vaccines (or DNA in the case of Johnson & Johnson and AstraZenecas vaccines) would primarily remain in and around the vaccination site, i.e., your deltoid muscle, with a small amount draining into local lymph nodes.8, Pfizers data, however, show this isnt the case at all. Its very disconcerting. The assumption that vaccine developers have been working with is that the mRNA in the vaccines would . Clipboard, Search History, and several other advanced features are temporarily unavailable. It is a toxin that can cause damage in our body if it gets into circulation. 2011 Oct;17(10):881-90. doi: 10.1089/acm.2010.0481. Read our disclaimer for details. 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). Most of the studies referenced by EMA are not available on the internet, but can be requested as was done by the Citizens petition. 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. Using Luciferine to follow biodistribution of a product is common practice. Not so. You can also boost your sulfate by taking Epsom salt baths. 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. 8.8. 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. The take-home message Kendrick delivers is that If you damage the lining of blood vessel walls, blood clots are far more likely to form. (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). We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. For an LNP-mRNA vaccine, DNA vaccine, or recombinant virus vaccine, a biodistribution study with the SARS-CoV-2 vaccine candidate is generally needed. People will continue to gather evidence supporting the vaccine, and people will continue to gather evidence against the vaccine. Bridle emphasized that the spike protein could cross the blood-brain barrier, causing neurological damage, explaining why fatal blood clots are often seen in the brain. Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells. At vascular endothelium, ACE2 performs conversion of angiotensin II to angiotensin (17). 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. Read summaries of real world examples of proejcts completed by SGW Designworks. Our democracy no longer represents the people. https://t.co/bvncGZWV4v pic.twitter.com/aNxH6bkAS5. 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. Bridle also cites recent research showing the spike protein remained in the bloodstream of humans for 29 days. 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 . The biodistribution of BNT162b2 was examined as an alternative marker. 8600 Rockville Pike Bridle maintains the Vaccine Adverse Event Reporting System (VAERS) database presents evidence of breastfeeding infants encountering bleeding disorders in the gastrointestinal tract. Documents obtained from Japanese regulatory agency reveal that Pfizer biodistribution studies showed that mRNA and spike proteins circulate widely throughout the body. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern." Apart from its role in energy production, mitochondria are crucial for innate immunity, reactive oxygen species (ROS) generation, and apoptosis; all of these are important in COVID-19 pathogenesis. 2. Why do we need it. I highlighted important points for easier reading. Shedding is the dissemination of the viral vectors (e.g. The biodistribution was also studied in rats, using radiolabeled LNP and luciferase modRNA (study 185350. SARS coronavirus 2 (SARS-CoV-2) enters cell by attaching to angiotensin converting enzyme 2 (ACE2) receptors on cell surface Following infection, there is internalization and downregulation of ACE2 receptors. Prions are membrane proteins and when they misfold, they form crystals in the cytoplasm resulting in prion disease. and transmitted securely. In a recent interview1 with Alex Pierson (above), Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., dropped a shocking truth bomb that immediately went viral, despite being censored by Google. Theranostics. The bioanalysis methods appear to be adequate. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. Please send me all info on any new updates. 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. 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. Is it a safe assumption that it stays in the shoulder muscle? 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.

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