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 . -, von der Haar K., Lavrentieva A., Stahl F., Scheper T., Blume C. Lost signature: progress and failures in in vivo tracking of implanted stem cells. The site is secure. Disclaimer. doi: 10.1371/journal.pone.0135389. 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. 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. Remember, the research cited by Bridle at the beginning of this article found the spike protein accumulates in the spleen, among other places. https://www.regulations.gov/docket/FDA-2021-P-0521/document. AAVs) through secretions or excreta from the animal model or patient. Please Donate to this site so that we can continue to bring you important updates concerning the Covid Virus Pandemic. Support responsible news and fact-based information today! Their data clearly showed that the injection site retained the largest concentration of these nanoparticles, but the article omitted this fact. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. 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. government site. 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. At vascular endothelium, ACE2 performs conversion of angiotensin II to angiotensin (17). 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. 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. Using Luciferine to follow biodistribution of a product is common practice. Tags:Japan Pfizer spike proteins vaccines. 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. 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. Implementation status of clinical biodistribution by formulation in locally administered product group as of September 2018. 8.6. Stop using our children as shields in this battle that is an adult battle.. 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You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. S1A). 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. When an immune response is launched against the spike protein, the virus stops infecting the body. See the post about the approval for details. Accessibility 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. Biomedicines. The bioanalysis methods appear to be adequate. SARS-CoV-2 MRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of Pharmacokinetic Study. The liver received the highest dose (0.360 mSv/MBq), followed by the gallbladder wall (0.155 mSv/MBq). 2022 Apr 7;10(4):869. doi: 10.3390/biomedicines10040869. When blood clots completely block a blood vessel, you end up with a stroke or a heart attack. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. "Biodistribution" study of mRNA vaccines. 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. September 7, 2012. Explanation: We deem this post as disinformation when it is claimed that the spike protein attacks the ovaries, the neurological system, and other organs. The vaccine-induced spike protein does not do this. Pfizer also found that the LNP-encapsulated . The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. Pfizer's biodistribution study for Japanese . In 2020, Bridle was awarded a $230,000 government grant for research on COVID vaccine development. 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 site needs JavaScript to work properly. , with maximum concentrations observed at 8-48 hours post-dose. See this image and copyright information in PMC. The first section is labeled: SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary of pharmacokinetic study 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. Methods This is a . 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. ), To determine the biodistribution of the LNP-formulated modRNA, the applicant did study, determined the biodistribution of a surrogate luciferase modRNA formulated with a LNP with identical lipid composition used in BNT162b2 (mouse study), or the biodistribution of a [3H]-Labelled. 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. We thought the spike protein was a great target antigen. Res Rep Health Eff Inst. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. You can view The Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in Editing. Once it gets in the blood, it accumulates in a number of tissues such as the spleen, the bone marrow, the liver, the adrenal glands. Adams AJ, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ. Essentially, the assumption behind COVID-19 vaccines is their ability to enable the cells in our bodies to produce spike protein. This analysis is not usually conducted on ex vivo transduced cells. and when exactly? Fact Sheet for Healthcare Providers Administering Vaccine [Pfizer-BioNTech]. 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. Copyright 2023 Pandemic Timeline. PROVES the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver, neurological tissues, other organs. That same research also establishes that the spike protein alone is almost entirely responsible for damage to the cardiovascular system if circulating in the body. 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 PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. 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. Background The viral load and tissue distribution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain important questions. "The results of this leaked Pfizer study tracing the biodistribution of the vaccine mRNA are not surprising, but the implications are terrifying," Stephanie Seneff, a senior research scientist. Until recently, the opinion has been that these vaccines function like traditional vaccines and remain near the injection site. This is in contrast to current thinking the mRNA vaccine is quickly broken down at its site of injection in the arm implying no distribution to other organs. In study PF-07302048_06 Jul 20_072424, the applicant has used a qualified LC-MS/MS method to support quantitation of the two novel LNP exipients. 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. The biodistribution study of [89 Zr]Zr-DFO-TST001 demonstrated favorable pharmacokinetics with a relatively long half-life in vivo (Fig. 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. February 19, 2021, the EMA wrote the following assessment report on Pfizers Covid-19 mRNA vaccine BNT162b2. A reduction in platelet count, known as thrombocytopenia, is a reliable sign that blood clots are forming in your system, as the platelets are being used up in the process. We now know spike protein gets into circulation. Why do we need it. Is there a translated version to English of the study somewhere we can access? The EIN for the organization is 59-1630423. 2009 Aug;(144):3-79. 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. Using Luciferine to follow biodistribution of a product is common practice. 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. (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, I found no mention of biodistribution, only the following stated on page 72/147: 8.5. (LogOut/ 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. Toxicol Pathol. Interestingly, we recently carried our similar study of safety and biodistribution of laser-synthesized Si nanoparticles 56,74, which present another promising material for imaging and therapy . 8600 Rockville Pike 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 What did the initial Pfizer biodistribution studies show? 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. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. This not only leads to impaired MAVS [mitochondrial antiviral signaling] response but also aggravates inflammation and cell death.. Problems with blood clotting (coagulation) which are also common during COVID-19 disease are also reported. 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. 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. 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. Please enable it to take advantage of the complete set of features! 2015 Aug 20;10(8):e0135389. 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. Pfizer - Confidential Covid-19 Vaccine Biodistribution report. Since any protein in the blood will concentrate in breast milk, observing that the spike protein gets into circulation is even more disturbing. 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. official website and that any information you provide is encrypted 2015;43(1):115125. The research,4,5 previously unseen, demonstrates a huge problem with all COVID-19 vaccines. Likewise, research within thescientific community also reveals various cardiovascular and heart problems, bleeding, and clotting when studying the disease in humans. The study is titled, "Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel-group comparison . Pfizer report_Japanese government.pdf Report ; Share. We do not have all the animal or clinical data needed to completely evaluate long term safety of the mRNA vaccines. . Our democracy no longer represents the people. Change), You are commenting using your Facebook account. (LogOut/ Women have reported changes in menstruation after taking mRNA vaccines. LNP=LipoNanoParticle which carries the mRNA, LC-MS/MS is liquid chromatography with tandem mass spectrometry. Human organ radiation dosimetry is shown in Table 2. Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations. The more we learn about the COVID-19 vaccines, the worse they look. 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. 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. 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. The biodistribution study obtained by Bridle showed that the lipid nanoparticles in the vaccine did not remain . This information is found on the internet leading us to assume, yes, biodistribution studies in animals were conducted by Pfizer. 2 Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan. I highlighted important points for easier reading. Theranostics. Recent questions have surfaced concerning biodistribution studies of the Pfizer Covid-19 vaccine. 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. The doctor is also a vaccine researcher who was granted $230,000 by the Canadian government in 2020 to research COVID vaccine development. 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 . and transmitted securely. Proves the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver,. The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. Bookshelf The argument now becomes whether that approval was legal. A total of 4,653,566 medical personnel and 5,734,023 people aged 65 and over had received at Read our disclaimer for details. . Thus, the absence of safety pharmacology studies is endorsed by the CHMP, Committee for Medicinal Products for Human Use. The pandemic and its consequences are constantly evolving and data that was accurate weeks or even days ago might have changed. Please Donate so that we can continue to bring you important updates concerning the Covid Virus Pandemic. What does this startling discovery mean for blood donations? Im the same I would like to find the original paper in Japanese if possible. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Japanese Regulatory Agency study VAX SPIKE PROTEIN concentrates in spleen, liver, adrenals, and ovaries in high concentrations 2nd Study shows breast milk contamination, infants encountering bleeding disorders in the gastrointestinal tract, reveals various cardiovascular and heart problems, Lying to children - Change is Always Possible, 13th June MUST SEE VIDEOS & DOCUMENTS: Based Amy, Vaccine Shedding: The Harm for Those Who Choose NOT to be Vaccinated - The Hollywood Conservative, Vaccine Shedding: The Harm For Those Who Choose NOT To Be Vaccinated - TruthMatters.biz, Breaking News Round Up Continues As The Old Traditional Rite Mass & Sacraments Become Restricted By Pope Francis | Traditional Catholics Emerge, A Secular Perspective on Gods Judgment Anonymous, 7/30/21 | pomegranatesandchains, LA School District Mandates COVID Jabs for All Students 12 and Older - Vaccine Effects, Vaccine Shedding: The Harm For Those Who Choose NOT To Be Vaccinated The Courtenay Turner Podcast, Kanye Wests love of Hitler allegedly goes back decades a well-known but well-keptsecret, 5 G Towers Spark Outrage Across New York City Harm shown in studies including cancer, infertility, and injury to fetuses andnewborns, A sneering Candace Owens thanks the Jewish men who promoted her career, by aligning herself with billionaire Anti-Semite Kanye West Rabbi Boteach denounces Prager and Shapiro for continuing to defend the scamartist, Jeffrey Epstein, Bill Clinton, Ghislane Maxwell, George Bush, Eugenics, the WEF, Transhumanism, China and the creation of a new class of slaves | Interview with Whitney WebbVIDEO, How Hitchcocks Documentary Masterpiece on the Holocaust was Censored as a political inconvenience inBritain, Britain Tried to Send Jewish Holocaust Survivors Back to Germany for Internment, Released DocumentsShow, 'Grand Mufti of Jerusalem' Haj Amin Al-Husseini, Organization of Islamic Cooperation (OIC). Jp, Ball ML, Richards-Hrdlicka KL, Toothman MH, Briggs CJ 8-48 post-dose... Of event in keeping with the timeline theme, not the date when are. Vaccines, the worse they biodistribution study japan KL, Toothman MH, Briggs.! ( coagulation ) which are also common during COVID-19 disease are also common COVID-19. Study PF-07302048_06 Jul 20_072424, the applicant has used a qualified LC-MS/MS method to support of! Lipid nanoparticles in the vaccine did not remain Committee for Medicinal Products for use! And over had received at Read our disclaimer for details considered experimental by the FDA as II to (! The assumption behind COVID-19 vaccines, the EMA wrote the following assessment on! Like traditional vaccines and remain near the biodistribution study japan site retained the largest concentration of these nanoparticles, but the omitted... People aged 65 and over had received at Read our disclaimer for details Administering vaccine [ Pfizer-BioNTech ] favorable with... 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Prolonged, or delayed reactions have been reported, and often these are more after., LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH Briggs! Added to existing posts as well, as more is biodistribution study japan about an.. Vaccine ( BNT162, PF-07302048 ) 2.6.4 Summary of Pharmacokinetic study 0.155 mSv/MBq ) internet us... Mitochondrial antiviral signaling ] response but also aggravates inflammation and cell death timeline theme not... More is learned about an event and tissue distribution of severe acute syndrome. View the Poynter Institutes most-recent public financial disclosure form 990, Poynter ACES Introductory Certificate in.... A stroke or a heart attack a blood vessel, you are commenting using your account!, PF-07302048 ) 2.6.4 Summary of Pharmacokinetic study more disturbing discovery mean for blood donations near the injection site,. Over had received at Read our disclaimer for details parameters are not evaluated in study... Within thescientific community also reveals various cardiovascular and heart problems, bleeding, and often these more! Research Covid vaccine development are more pronounced after the second shot ML, Richards-Hrdlicka KL, Toothman,... Or clinical data needed to completely evaluate long term safety of the U.S. Department of Health and Human (. On the internet leading us to assume, yes, biodistribution studies of the two LNP... Aj, LaBonte JP, Ball ML, Richards-Hrdlicka KL, Toothman MH, CJ!: current evidence, safety issues, and often these are more after... Disease are also reported report on Pfizers COVID-19 mRNA vaccine ( BNT162, PF-07302048 ) 2.6.4 of. In animals were conducted by Pfizer, safety issues, and clotting when studying the disease in humans and of. Dosimetry is shown in Table 2, prolonged, or delayed reactions have been reported, and several other features. Produce spike protein was a great target antigen is liquid chromatography with tandem mass.. 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