Guidelines on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. This site needs JavaScript to work properly. 1. Using Luciferine to follow biodistribution of a product is common practice. 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. Pfizer's biodistribution study for Japanese . 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. . (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). This false claim originated from: viral social media post. Over 48 hours, distribution was mainly observed to liver, adrenal glands, spleen and ovaries. 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. Even my doctor, who is against it, could not tell me public sources. 2020 Jun 1;18:176-188. doi: 10.1016/j.omtm.2020.05.029. 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. Did Pfizer Fail to Perform Industry Standard Animal Testing Prior to Initiation of MRNA Clinical Trials? It only looked at where the lipid nanoparticles go. Some people, this gets into circulation, and when that happens, in some people, they can cause damage, especially to the cardiovascular system., https://uncoverdc.com/2021/05/31/vaccine-expert-warns-we-made-a-big-mistake/, In paragraph 3 you quote him as saying inter alia, regarding the spike protein that We thought the spike protein was a great target antigen; we never knew it was a toxin. However, para 8 he states We have known for a long time that the spike protein is a pathogenic protein. The readouts were performed at 6h, 24h, 48h, 72h, 6d and 9d post IM injection (intended clinical route) in the right and left hind leg with each 1 g (total of 2g) of LNP-formulated luciferase RNA. Change), You are commenting using your Twitter account. If any decision is difficult to make, it is usually because one does not have enough facts. My intent is to bring you facts, not conjecture or opinion. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. 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. Yet he was 100% correct. Our democracy no longer represents the people. 1 Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Thus, a low ACE2 activity subsequent to SARS-CoV-2 infection leads to imbalance in renin-angiotensin system with relative excess of angiotensin II. Assessments of shedding can be utilized . 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'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. I highlighted important points for easier reading. Human organ radiation dosimetry is shown in Table 2. The biodistribution was also studied in rats, using radiolabeled LNP and luciferase modRNA (study 185350. The liver expression is also supportive of the data from the rat PK study and the findings in the rat repeat-dose toxicological study showing reversible liver vacuolation and increased GGT levels. 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. A recent study from the University of Rochester reveals how the biodistribution kinetics and the affinity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for many different organs . This toxin, Bridle notes, can cause cardiovascular damage and infertility a claim echoed by researchers such as Stephanie Seneff, Ph.D., and Judy Mikovits, Ph.D., whom Ive interviewed about these issues. Implementation status of clinical biodistribution by formulation in locally administered product group as of September 2018. They confirmed what I had found. 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). Following are pages from the Pfizer Covid vaccine biodistribution study referred to above. 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. . 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. See this image and copyright information in PMC. It is a toxin. 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. The radiolabeling data, measuring distribution to blood, plasma and selected tissues, of IM injection of a single dose of 50 g mRNA over a 48-hour period is considered more sensitive than the bioluminescence method and indicate a broader biodistribution pattern than was observed with bioluminescence. In the current work, we aimed to investigate the impact of formulation type on biodistribution profile . ), o determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study). The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. It only means the studies are not available on an internet search. 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. its important. To combat the toxicity of the spike protein, youll want to optimize autophagy, which may help digest and remove the spike proteins. 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 . 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. This is a nonprofit education and research site. Nothing whatsoever on this site is monetized, not even the Amazon links. I therefore claim fair use of materials featured here. To find out what is new, check out the above sidebar item, Recently Modified Posts. New posts are added according to date of event in keeping with the timeline theme, NOT the date when they are created. Material is often added to existing posts as well, as more is learned about an event. To make best use of this site, consider using the tags, categories, and search box. Many posts also have a See also, on this site list. For more details about the purpose and style of this site, please see the About page. When administered, COVID-19 vaccines are injected into the shoulder musclenot into the blood. https://www.regulations.gov/docket/FDA-2021-P-0521/document. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. "We made a big mistake," Bridle says. No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2. We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. . The biodistribution study of [89 Zr]Zr-DFO-TST001 demonstrated favorable pharmacokinetics with a relatively long half-life in vivo (Fig. doi: 10.1371/journal.pone.0135389. All Rights Reserved. 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. 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. The research, previously unseen, demonstrates a huge problem with all COVID-19 vaccines 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. 8.6. PMC The attack causes damage to the lining, which results in inflammation. 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. . 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. Characteristics of Extracellular Vesicles and Preclinical Testing Considerations Prior to Clinical Applications. Dr. Bret Weinstein, Dr. Robert Malone, Steve Kirsch Over 48 hours, distribution from the injection site to most tissues occurred, with the majority of tissues exhibiting low levels of radioactivity. As expected with an mRNA product, the luciferase expression was transient and decreased over time. Bridle explains the study absolutely refutes the premise that the COVID-19 vaccine stays in the shoulder muscle, asserting: The short answeris absolutely not. Change), You are commenting using your Facebook account. We thought the spike protein was a great target antigen. 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. J Altern Complement Med. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. 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. This information is found on the internet leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer. I wanted links for my wife who is Japanese and could not understand my resistance to them. Data were . 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. This analysis is not usually conducted on ex vivo transduced cells. "Biodistribution" study of mRNA vaccines. 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. PLoS One. (a) DNA extraction, (b) PCR detection,, MeSH Read our disclaimer for details. mRNA-1273 . Specific alterations make it far more toxic than that found on the virus itself. 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 .gov means its official. and when exactly? It has been one of the hardest blogs for me to write and why you did not receive a blog last week! Unauthorized use of these marks is strictly prohibited. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. 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. 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. 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. The vaccine-induced spike protein does not do this. We thought the spike protein was a great target antigen; we never knew it was a toxin. According to Kendrick, all of them have two things in common:12. 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. The study started last September 16, 2020 and the planned end date is March 31, 2022. Metabolomic studies suggest that SARS-CoV-2 inhibits mitophagy. The FDA has broken at least two federal rules to release these shots under the EUA. It also modulates the adhesion of platelets to the endothelium. 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). 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. Methods This is a . Remember to check the date when the fact-check you are reading was published before sharing it. Concise review: quantitative detection and modeling the in vivo kinetics of therapeutic mesenchymal stem/stromal cells. Biodistribution; Cell therapy product; Imaging; MRI; PET; SPECT; qPCR. 2. Explanation: When you receive the covid vaccine, it will not impair the function of your ovaries, just as the coronavirus will not. Okay I just noticed the link please ignore. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. 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. No published research data on biodistribution of the mRNA vaccines in animals can be found on the internet. -, Brooks A., Futrega K., Liang X., Hu X., Liu X., Crawford D.H.G. Please send me all info on any new updates. Arthritis Care Res (Hoboken). Spike Protein Is Very Dangerous, Its Cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein). After drying, the sections were exposed to a BAS imaging plate (FUJIFILM, Tokyo, Japan). Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of MRNA-1273 Vaccine Recipients. So, by vaccinating people we are inadvertently inoculating them with a toxin.. S1A). The study is titled, "Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel-group comparison . Image . Pfizer also found that the LNP-encapsulated . Production and hosting by Elsevier B.V. All authors declare that they have no competing interests. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Alzheimer disease 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. Recently, there has been speculation regarding potential safety signals associated with COVID-19 mRNA vaccines. Women have reported changes in menstruation after taking mRNA vaccines. SARS-CoV-2 MRNA Vaccine (BNT162, PF-0 7302048)2.6.4 . When a substance is injected into the body, tracking where it goes- its biodistribution is important to know. In what organs can you find the vaccine? 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. Please Donate so that we can continue to bring you important updates concerning the Covid Virus Pandemic. All of these risk factors have something in common: Theyre all associated with mitochondrial dysfunction. Not believing the outcome of my research, I called for help from my PhD friends at Penn State in the Materials Research Institute. Its the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination, Bridle told Pierson.10. 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. 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. Autoradiographic images were obtained using Amersham Typhoon Scanner (GE Health Life Sciences, IL, U.S.A.). 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.. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. 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. 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