They confirmed what I had found. Biodistribution (BD) analysis is performed to determine the distribution and the persistence of the vector/virus to target and nontarget tissues following direct in vivo administration in animals. We thought the spike protein was a great target antigen; we never knew it was a toxin. In addition, no findings on vital organ functions have been recorded in the repeat dose toxicology studies. Sunlight also has other benefits besides making vitamin D. Use time-restricted eating and eat all your meals for the day within a six- to eight-hour window. The short answer is: absolutely not. Elaborating on the implications of these findings, he remarked: We have known for a long time that the spike protein is a pathogenic protein. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. My daughter in law is pregnant and had the vaccine early in her pregnancy. Shedding is the dissemination of the viral vectors (e.g. What is the clinical outcome? 2011 Oct;17(10):881-90. doi: 10.1089/acm.2010.0481. The Ministry of Health, Labour and Welfare . Would you like email updates of new search results? The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines. 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. . No evidence of vaccine-related macroscopic or microscopic findings were found in the ovaries in the repeat-dose toxicity studies (Study 38166 and Study 20GR142), were identified in the DART, Developmental and Reproductive Toxicology, study.*, The bottom line is mRNA Covid vaccines are still considered experimental by the FDA as. 2015;43(1):115125. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. 2 Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan. 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 . This analysis is not usually conducted on ex vivo transduced cells. 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. The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. 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. 2015 Aug 20;10(8):e0135389. 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 study is titled, "Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel-group comparison . Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. When an immune response is launched against the spike protein, the virus stops infecting the body. 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. Both are important for the clearing of cellular debris, including these spike proteins. Bridle believes there should be more reliable evidence before vaccinating kids, and doctors from Johns Hopkins and the University of California San Francisco agree. Canadian immunologist and vaccine researcher Byram Bridle, Ph.D., has gained access to Pfizer's biodistribution study from the Japanese regulatory agency. 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. The argument now becomes whether that approval was legal. Pfizer also found that the LNP-encapsulated . But, as you can see below, unlike Bridle, Politifact neglected to go beyond interviewing someone with such a huge stake in the vaccines success. 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. This information is found on the internet leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer. Background The viral load and tissue distribution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain important questions. It was a pre-clinical biodistribution study. Since spike proteins cause the coronavirus infection, they are the catalyst used in 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. It only looked at where the lipid nanoparticles go. Thus, there is accumulation of damaged and dysfunctional mitochondria. Documents obtained from Japanese regulatory agency reveal that Pfizer biodistribution studies showed that mRNA and spike proteins circulate widely throughout the body. 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. People will continue to gather evidence supporting the vaccine, and people will continue to gather evidence against the vaccine. 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. . Furthermore, in key studies designed to test whether the vaccine remains near the injection site or travels throughout the body, Pfizer did not even use the commercial vaccine (BNT162b2) but instead relied on a surrogate mRNA producing the luciferase protein. Please Donate to this site so that we can continue to bring you important updates concerning the Covid Virus Pandemic. official website and that any information you provide is encrypted Bridle maintains the Vaccine Adverse Event Reporting System (VAERS) database presents evidence of breastfeeding infants encountering bleeding disorders in the gastrointestinal tract. Please send me all info on any new updates. (LogOut/ While all of this is highly problematic, there is help. I want to pass it on to some doctors in Japan who have no idea about its existence. 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. Prions are membrane proteins and when they misfold, they form crystals in the cytoplasm resulting in prion disease. Well, back in May 2021, I, along with some international colleagues, looked at a document that Pfizer had submitted to the Japanese health regulatory agency. Dysfunctional mitochondria predispose to oxidative stress and loss of cellular function and vitality. 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. 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.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. New Peer Reviewed Study on COVID-19 Vaccines Suggests Why Heart Inflammation, Blood Clots and Other Dangerous Side Effects Occur. 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. 1. This assumption was wrong. Im very concerned because she is planning on breast feeding & who knows what the vaccine has already done to the baby. PLoS One. 2021 The Japanese Society for Regenerative Medicine. Is there a translated version to English of the study somewhere we can access? 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. Ultimately at this juncture, it is a personal decision considering the risk vs. benefit ratio. The Carton Theme by bavotasan.com. Bittorf P, Bergmann T, Merlin S, Olgasi C, Pullig O, Sanzenbacher R, Zierau M, Walles H, Follenzi A, Braspenning J. Mol Ther Methods Clin Dev. When in circulation, the spike protein can bind to the receptors that are on our platelets and the cells that line our blood vessels. When a substance is injected into the body, tracking where it goes- its biodistribution is important to know. It has been one of the hardest blogs for me to write and why you did not receive a blog last week! The research examined thirteen young healthcare workers who had received the Moderna vaccine. I thought this would be an easy blog to write, cut and dry. The biodistribution study obtained by Bridle showed that the lipid nanoparticles in the vaccine did not remain . 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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. Change). This document . 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. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. 3 Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan. Change), You are commenting using your Facebook account. 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. The biodistribution of hybrid nanostructures is a major subject of current nanomedical research. If the damage is serious enough, uncontrolled cell death can occur, which in turn leaks mitochondrial DNA (mtDNA) into your bloodstream.13, Aside from being detected in cases involving acute tissue injury, heart attack and sepsis, freely circulating mtDNA has also been shown to contribute to a number of chronic diseases, including systemic inflammatory response syndrome or SIRS, heart disease, liver failure, HIV infection, rheumatoid arthritis and certain cancers.14 As explained in COVID-19: A Mitochondrial Perspective:15. The biodistribution of BNT162b2 was examined as an alternative marker. It is important that your sauna is hot enough (around 170 degrees Fahrenheit) and does not have high magnetic or electric fields. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. Unable to load your collection due to an error, Unable to load your delegates due to an error. Careers. 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. As of August 23, 2021, the Pfizer-BioNTech inoculation is now approved under the brand name Comirnaty. Vaccine Researcher Admits Big Mistake, Says Spike Protein Is Dangerous Toxin.. Before 2015;99(23):99079922. The spike protein gets into the blood, circulates through the blood in individuals over several days post-vaccination. Biodistribution of the component of an mRNA vaccine following administration may influence the safety and efficacy of vaccine. "Biodistribution" study of mRNA vaccines. 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. 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. 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 . Spike Protein Is Very Dangerous, Its Cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein). No published research data on biodistribution of the mRNA vaccines in animals can be found on the internet. Parkinsons disease is a prion disease that has been traced back to prions originating in the spleen, that then travel up to the brain via the vagus nerve. In Japan, 10 fatal cases (five men and women) have been reported to date. AAVs) through secretions or excreta from the animal model or patient. Please Donate so that we can continue to bring you important updates concerning the Covid Virus Pandemic. 8600 Rockville Pike The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. Pfizer report_Japanese government.pdf Report ; Share. As expected with an mRNA product, the luciferase expression was transient and decreased over time. 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. 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. 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. Copyright 2023 Pandemic Timeline. 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. What is the real truth? Essentially, the assumption behind COVID-19 vaccines is their ability to enable the cells in our bodies to produce spike protein. Genotoxicity of 1,3-butadiene and its epoxy intermediates. 2018;7(1):7886. . Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Alzheimer disease 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. Theres also evidence suggesting the SARS-CoV-2 spike protein may be a prion, which is yet another piece of really bad news, particularly as it pertains to vaccine-induced spike protein. 12 . The study started last September 16, 2020 and the planned end date is March 31, 2022. Its past time to #RevoketheEUA https://t.co/ZdeHCKXyPb, BREAKING: Dr. Byram Bridle sent me his report: 'Why Parents, Teens, and Children Should Question the COVID-19 Vaccine'He's an Associate Professor of Viral Immunology at the University of Guelph who brought attention to the Pfizer Japanese study. 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. Find the original research and move on! There are many different types of vasculitis, including Kawasakis disease, antiphospholipid syndrome, rheumatoid arthritis, scleroderma and Sjogrens disease. Explanation: We deem this post as disinformation when it is claimed that the spike protein attacks the ovaries, the neurological system, and other organs. 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. mRNA-1273 . It is false to claim that Pfizer's biodistribution study showed lipid nanoparticles accumulating in the highest concentration in the ovaries. Time-restricted eating will upregulate autophagy, while sauna therapy, which upregulates heat shock proteins, will help refold misfolded proteins and also tag damaged proteins and target them for removal. Biodistribution of nanoencapsulated bioactive compounds is primarily determined by the size, shape, chemical composition and surface properties of the encapsulating nanoparticle, and, thus, less dependent on the physicochemical properties of the active pharmaceutical ingredient encapsulated. Why are these questions surfacing now? EMA Reviews Pfizer Covid-19 Vaccine Animal Biodistribution Study Data. We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. Over 48 hours, distribution was mainly observed to liver, adrenal glands, spleen and ovaries. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. Shockingly, according to Bridle, the COVID-19 vaccine is different from traditional vaccines. Arthritis Care Res (Hoboken). Clipboard, Search History, and several other advanced features are temporarily unavailable. The results from this study supported many of the results from the biodistribution-only studies. Read our disclaimer for details. Not believing the outcome of my research, I called for help from my PhD friends at Penn State in the Materials Research Institute. Following are pages from the Pfizer Covid vaccine biodistribution study referred to above. Canadian vaccine expert Dr. Byram Bridle recently spoke of the terrifying reasons serious side effects, including heart inflammation and vaccine-induced immune thrombotic thrombocytopenia (VITT), may occur in those who have received the COVID-19 vaccine. "We made a big mistake," Bridle says. Multifunctional NP-based technologies with diagnostic and therapeutic functions are being developed for in vivo applications. Its very disconcerting We have known for a long time that the spike protein is a pathogenic protein. Among many other things, the glycocalyx contains a wide variety of anticoagulant factors, including tissue factor inhibitor, protein C, nitric oxide and antithrombin. SARS-CoV-2which has been shown to cross the blood-brain barrier in mice and cause many kinds of heart, blood vessel, and brain damagehas a spike protein on its surface, allowing the virus to infect our bodies. Support responsible news and fact-based information today! 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. Stem Cells Transl Med. 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). Remember, the research cited by Bridle at the beginning of this article found the spike protein accumulates in the spleen, among other places. Over 48 hours, distribution from the injection site to most tissues occurred, with the majority of tissues exhibiting low levels of radioactivity. 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. Thus, the absence of safety pharmacology studies is endorsed by the CHMP, Committee for Medicinal Products for Human Use. 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. Characteristics of Extracellular Vesicles and Preclinical Testing Considerations Prior to Clinical Applications. 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. We never knew the spike protein itself was a toxin and was a pathogenic protein. Why the confusion? Spike protein does not attack anything, it only aims to activate the immune response, it is not the same as coronavirus spike protein and after vaccination, it is created in a dose 100 thousand times lower than in viral infection. This false claim originated from: viral social media post. Current Red Cross guidelines state, In most cases, theres no deferral time if you receive a vaccine, a protocol which doesnt sit well with Bridle, who remarked, We dont want [a] transfer of these pathogenic spike proteins to fragile patients who might need a blood transfusion. HHS Vulnerability Disclosure, Help Human organ radiation dosimetry is shown in Table 2. 2012 Mar;64(3):375-83. doi: 10.1002/acr.21558. 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. Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of MRNA-1273 Vaccine Recipients. 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 . Avoid all vegetable oils and processed foods. 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. (LogOut/ In 2020, Bridle was awarded a $230,000 government grant for research on COVID vaccine development. They significantly increase your risk of death, in some cases raising mortality by 50 times compared to people who do not have these conditions. The study has been supported financially by the Japan Agency for Medical Research and Development and Kitasato Institute. Stop using our children as shields in this battle that is an adult battle.. 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. The biodistribution was also studied in rats, using radiolabeled LNP and luciferase modRNA (study 185350. 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. After spending 20 hours of research, I found there are. Keywords: 2009 Aug;(144):3-79. Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. . Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. The bioanalysis methods appear to be adequate. 8.6. So by vaccinating people, we are inadvertently inoculating them with a toxin.. 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. Consensus treatment plans for induction therapy of newly diagnosed proliferative lupus nephritis in juvenile systemic lupus erythematosus. 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. Researcher Admits Big Mistake, & quot ; biodistribution & quot ; Bridle Says database records fact-checks since! Discovery research, previously unseen, demonstrates a huge problem with all COVID-19 is! The clearing of cellular debris, including these spike proteins cause the coronavirus infection, they are the catalyst in., and people will continue to bring you important updates concerning the Covid virus Pandemic is! Weinstein ) problem with all COVID-19 vaccines is their ability to enable the cells our. 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