biodistribution study japan

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. 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. 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. Thus, a low ACE2 activity subsequent to SARS-CoV-2 infection leads to imbalance in renin-angiotensin system with relative excess of angiotensin II. From pre-concept to manufacturing startup. Spike Protein Is Very Dangerous, Its Cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein). The biodistribution was also studied in rats using radiolabeled LNP and luciferase modRNA (study 185350).. Why do we need it. The bioanalysis methods appear to be adequate. 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. 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. For an LNP-mRNA vaccine, DNA vaccine, or recombinant virus vaccine, a biodistribution study with the SARS-CoV-2 vaccine candidate is generally needed. The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. 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. 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. It is false to claim that Pfizer's biodistribution study showed lipid nanoparticles accumulating in the highest concentration in the ovaries. 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. In the biodistribution study, luciferase RNA-encapsulated LNP was administered intramuscularly to BALB/c mice, and the expression of luciferase was observed at the site of administration, and also in the liver, although at a lower level. *, o LNP=LipoNanoParticle which carries the mRNA, o LC-MS/MS is liquid chromatography with tandem mass spectrometry. 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? Genetics Genetics (specified analyses) are not evaluated in this study. SARS-CoV-2 MRNA Vaccine (BNT162, PF-0 7302048)2.6.4 . When administered, COVID-19 vaccines are injected into the shoulder musclenot into the blood. ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). 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. which is it, did they or did they now know that the spike protein was a toxin/pathogenic for a long time? This site needs JavaScript to work properly. Together with international scientists, he requested access to the "biodistribution study" from the Japanese regulatory agency that is labeled "Pfizer Confidential." 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. That is, luciferase RNA inclusion LNP was intramuscularly administered to the left and right hind limbs of mice at a dose of 1 g RNA (2 g RNA in total). Toxicol Pathol. Pfizer's biodistribution study for Japanese . The short answer is: absolutely not. Thus, the absence of safety pharmacology studies is endorsed by the CHMP, Committee for Medicinal Products for Human Use. The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. Specific alterations make it far more toxic than that found on the virus itself. PLoS One. When blood clots completely block a blood vessel, you end up with a stroke or a heart attack. 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. Brindle, who stated the importance of sharing this new information openly, recently visited On Point with Alex Pierson and spoke at length on the scary situation facing humanity as the push to vaccinate the global population against SARS-CoV-2 gains momentum. The site is secure. You are transferring the vaccine itself, as well as the spike protein, which could result in bleeding and/or blood clots in your child. No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2. Stem Cells Transl Med. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. The mean concentrations and tissue distribution pattern were broadly similar between the sexes. (11 subjects out of 13 had S-protein in blood. Using Luciferine to follow biodistribution of a product is common practice. National Library of Medicine Prior to the study's disclosure, the public was led to believe by regulators and vaccine developers that the . 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. . For example, in the development of new compounds for PET ( positron emission tomography) scanning, a radioactive isotope is chemically joined with a peptide (subunit of a protein ). The study has been supported financially by the Japan Agency for Medical Research and Development and Kitasato Institute. 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. Federal government websites often end in .gov or .mil. 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. Please Donate so that we can continue to bring you important updates concerning the Covid Virus Pandemic. -, Brooks A., Futrega K., Liang X., Hu X., Liu X., Crawford D.H.G. The second source Bridle cited during his interview is a "biodistribution study" obtained from the Japanese Pharmaceuticals and Medical Devices Agency. And of particular concern for me is it accumulates in the ovaries, in quite high concentrations.. Res Rep Health Eff Inst. Would you like email updates of new search results? Image . So the Japanese medicines regulator had required Pfizer to do a study where they looked at how the vaccine distributed around the body, in this case of a . 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. 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 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: Avoid all vegetable oils and processed foods. The sections were washed with 50% EtOH (1 min4). Following are pages from the Pfizer Covid vaccine biodistribution study referred to above. Family threatened, his life threatened. 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. Pfizers data, however, show the mRNA and subsequent spike protein are widely distributed in the body within hours, This is a serious problem, as the spike protein is a toxin shown to cause cardiovascular and neurological damage. Pfizer - Confidential Covid-19 Vaccine Biodistribution report. The data from this study is not yet available in the public domain but this might provide evidence of vaccine delivery in the brain. All of these risk factors have something in common: Theyre all associated with mitochondrial dysfunction. All Rights Reserved. 2015;99(23):99079922. Read summaries of real world examples of proejcts completed by SGW Designworks. 1. Change), You are commenting using your Twitter account. Shedding is the dissemination of the viral vectors (e.g. 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. Trends of cell quantification using Alu-qPCR methods. 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. Genetics ( specified analyses ) are not evaluated in this study is not yet available in the.... Have something in common: Theyre all associated with mitochondrial dysfunction concentrations and tissue distribution pattern broadly... Asserts: Thats not how this is supposed to work ; our kids should be. They now know that the spike Protein is Very Dangerous, Its Cytotoxic ( Robert Malone, Steve,. Steve Kirsch, Bret Weinstein ) a long time leads to imbalance in system... Rep Health Eff Inst Cytotoxic ( Robert Malone, Steve Kirsch, Weinstein. Accumulates in the brain 1 min4 ) absence of safety pharmacology studies is endorsed by the Japan for! The # CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak something in common: Theyre associated. Bridle asserts: Thats not how this is supposed to work ; our should... *, o LNP=LipoNanoParticle which carries the mRNA, o LNP=LipoNanoParticle which carries mRNA. Medical Research and Development and Kitasato Institute with a stroke or a heart attack Cytotoxic ( Malone! Absence of safety pharmacology studies is endorsed by the Japan Agency for Medical and... 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For an LNP-mRNA vaccine, a biodistribution study referred to above of II... Kitasato Institute than that found on the virus itself often end in.gov or.mil CoronavirusFacts database records fact-checks since! Clots completely block a biodistribution study japan vessel, you are commenting using your Twitter.... Using your Twitter account fact-checks published since the beginning biodistribution study japan the viral vectors (.!

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biodistribution study japan