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The Jaw Dropping Dr. Fauci Emails: Like Something Out Of A Bond Movie

The Jaw Dropping Dr. Fauci Emails: Like Something Out Of A Bond Movie June 3, 2020 Paul Joseph Watson The doctor who thanked Dr. Fauci for dismissing the Wuhan lab leak theory is the same guy who gave $600k to the lab, “investigated” it for the WHO and then acted as a Facebook fact checker censoring info on the Wuhan lab leak theory. You couldn't make this up. https://www.bitchute.com/video/1XqwDx0X5w9v/ = NEW MERCH: https://www.pjwshop.com/ DONATE: https://www.subscribestar.com/paul-joseph-watson CASH APP: https://cash.app/£PaulJosephWatson SUMMIT NEWS: http://summit.news/newsletter BITCOIN WALLET: 3EMQG9EhPkoFbX5F19RTGZs8rPqGYm2mp9 BITCOIN CASH WALLET: qrxhqz9ka423v68qwc7nyqc88q3mx9ea5gcpz88a0l LITECOIN WALLET: MSs2rWgM571WM3zUnL255gccoQAdz9L6CG ETHEREUM WALLET: 0x21221F5da5e70F46Bbfa755f89e312daDa51f115 Odysee: https://odysee.com/@PaulJosephWatson:5 Main Channel: https://www.youtube.com/channel/UCittVh8imKanO_5KohzDbpg Parler: https://parler.com/profile/PJW/posts Bitchute: https://www.bitchute.com/pauljosephwatson/ Telegram: https://t.me/pjwnews Twitter: https://twitter.com/PrisonPlanet Minds: https://www.minds.com/PaulJosephWatson Gab: https://gab.com/PrisonPlanet https://humansarefree.com/2021/06/dr-fauci-emails-covid-19.html

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Firefighters Denied Coverage by Veterans Affairs After Exposure to PFAS Firefighting Foam June 5, 2021 The VA and insurers have rejected claims from firefighters despite evidence linking PFAS foam and disease. When Kevin Ferrara was starting out in the Air Force in 1991, he and his fellow firefighters developed a method for cooling each other down. His training at Chanute Air Force Base in Illinois involved repeatedly putting jet fuel and other chemicals and debris into a pit, setting them on fire, and then putting the flames out with firefighting foam known as AFFF. Ferrara and the other members of the fire crew became unbearably hot as they stood around the fiery pit. For relief, they would cover each other with foam. “As we’re spraying each other, the substance would find its way under our collars and the cuffs of our sleeves. It would penetrate through the weak points of our suits,” Ferrara remembered. The sudsy foam did cool them down. Now, years later, Ferrara and many other civilian and military firefighters who were exposed to firefighting foam that contained the industrial chemicals known as PFAS are developing health problems that they believe are related to those occupational exposures. And despite ample evidence connecting PFAS exposure to multiple diseases, many are finding it difficult to convince others of the connection. While almost everyone has PFAS in their blood through exposure to water, dust and everyday products that contain the chemicals, firefighters may have greater contact with PFAS than any other group of workers. In addition to using — and often getting doused with — AFFF, it has become clear in recent years that the clothing that was supposed to protect them while fighting fires, known as turnout gear, is also saturated with PFAS. Given the frequent contact with the toxic chemicals, which accumulate in the body and cause kidney cancer, depressed immune function, and elevated cholesterol, among other health problems, it may not be surprising that firefighters have both relatively high levels of the chemicals in their blood and elevated rates of cancer diagnoses. Firefighters also have a death rate from cancers that is 14 percent higher than that of the general population, according to a study by the National Institute of Occupational Safety and Health. But some firefighters who have used AFFF now find themselves struggling not just with illnesses linked to the chemical-laden foam and firefighting gear, but also with getting coverage for benefits related to those illnesses. In April, Volunteer Firemen’s Insurance Services, a company that provides insurance and other services to firefighters and is a division of the Glatfelter Insurance Group, sent its policyholders a notice that the company would be applying a “pollution exclusion” to its coverage, specifying that “the application of the pollution exclusion is extended to any use of Class B firefighting foam containing PFAS.” The Glatfelter Insurance Group declined to answer questions for this story about how many firefighters and former firefighters are subject to its new pollution rider, which types of policies are affected, and why the company has chosen to exclude coverage of AFFF-related claims. Meanwhile, some former military firefighters who used the firefighting foam and wore the gear are struggling to get the Department of Veterans Affairs to recognize a connection between their workplace exposure and their illnesses. Ferrara, who has elevated triglyceride levels in his blood, Type 2 diabetes, and numbness in his feet and hands, all symptoms that he believes are related to his exposure to the chemicals while in the military, was unable to get the VA to pay for a blood test to measure the PFAS levels in his blood. The VA also denied his claim for disability benefits based on his exposure to the firefighting foam. Ferrara found that he wasn’t alone in meeting resistance from the hulking bureaucracy that provides health care to U.S veterans. As he learned more about the dangers of the foam that he had been told was harmless, he has become outspoken on the issue of the government’s obligation to take care of firefighters who were exposed to the chemicals in the line of duty. Through a Facebook group and email, he estimates that he has connected with at least 50 veterans who have developed cancer and other serious illnesses after using AFFF in the military and have had their claims for disability related to AFFF exposure denied by the VA. The VA provides these monetary benefits to veterans only if they can prove that an illness or injury was caused or exacerbated by their service. “The VA keeps pushing back, saying that since about 96 or so percent of Americans have PFAS in their blood, there’s no definitive correlation between AFFF and their medical illnesses,” said Ferrara. “But if you ask any firefighter, they’re going to tell you that’s BS.”
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Pfizer Skipped Critical Testing and Cut Corners on Quality Standards, Documents Reveal June 3, 2021 New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer COVID vaccine. New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer/BioNTech COVID vaccine, and that U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine. Regulatory documents revealed Pfizer didn’t thoroughly examine biodistribution and pharmacokinetics issues relating to its vaccine before submitting the vaccine to the European Medicines Agency (EMA) for review. In fact, in key studies — called biodistribution studies, which are designed to test where an injected compound travels in the body, and which tissues or organs it accumulates in — Pfizer did not use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA that produced the luciferase protein. According to TrialSite News, the EMA reviewers shared this explicit admission: “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Pharmacokinetics refers to the study of what the body does with a drug and the drug’s movement throughout the body — the time course of its absorption, bioavailability, distribution, metabolism and excretion. Regulatory documents also show Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies of its vaccine, as key studies did not meet good laboratory practice (GLP). Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies used as the basis for research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. “The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on the pressures of the pandemic,” said TrialSite founder and CEO Daniel O’Connor. “The challenge is that the processes, such as Good Laboratory Practices, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling.” O’Connor pointed to the example of generic repurposed drugs that when under evaluation, even if they are approved, must go through “ever more studies to prove their worth.” Yet in the case of the Pfizer vaccine, O’Connor said, “Pfizer was given more discretion even with a radically new life science-based technology.” According to TrialSite News, it’s standard practice for the EMA to disclose its assessment of investigational new drug submissions. In the case of Pfizer’s vaccine, the EMA assessment included a summary of the agency’s evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer — but the EMA did not disclose the results of Pfizer’s biodistribution studies in its public EMA summary. Studies submitted to the EMA were carried out using two methods: use of mRNA that produces the luciferase protein and use of a radioactive label to mark the mRNA. The studies revealed the majority of radioactivity initially remained near the injection site. But within hours, a subset of the stabilized mRNA-containing particles became widely distributed throughout the bodies of test animals. Rapporteur Filip Josephson, (a person appointed by an organization to report on the proceedings of its meetings) and Co-Rapporteur Jean-Michael Race suggested Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies performed and submitted by Pfizer were non-GLP. 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. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern.” This EMA observation corresponds with a growing number of adverse events and aligns with data TrialSite obtained through FOIA showing concentrations of LNP-formulated RNAs in the spleen, ovaries, other tissues and organs. TrialSite News contacted Dr. Robert W. Malone, the original inventor of mRNA vaccine technology and a senior regulatory specialist who serves as president of a prestigious European association who wished to remain anonymous. When asked to review and comment on the EMA assessment, Malone noted normal pharmacokinetic and pharmaco-toxicology studies had not been performed before EUA authorization for the product. “I was particularly surprised that the dossier of regulatory documents indicates allowance for use in humans based on non-GLP PK and Tox studies relying on formulations which are significantly different from the final vaccine,“ Malone said. After completing a review, TrialSite’s other source noted the following: “A quick review the Toxicology Section (2.3.3) of the European Medicines Agency (EMA) Assessment Report on Comirnaty (COVID-19 mRNA vaccine) issued on 19 February 2021, raises concerns about data applicability of preclinical study findings to clinical use: “To determine the biodistribution of the LNP-formulated modified mRNA (modRNA), the applicant did study distribution of the modRNA in two different non-GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA. “Thus, one might question the validity and applicability of non-GLP studies conducted using a variant of the subject mRNA vaccine. “In addition, no genotoxicity data were provided to EMA.” According to official government accounts, minimal risk is associated with COVID vaccines when compared to the risks of COVID infection. This belief forms the basis of the U.S. Food and Drug Administration’s Emergency Use Authorization approval, which is based on a risk-benefit analysis. However, a search in the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System (VAERS) revealed 294,801 reports of adverse events following COVID vaccines, including 5,165 deaths and 25,359 serious injuries between Dec. 14, 2020 and May 28, 2021. Though the U.S. government argues none of the deaths have been formally linked to COVID vaccines and the reported adverse event risk is low, the discovery of these documents and associated information may alter the risk-benefit assessment underlying the EUA decision, TrialSite News reported. As The Defender and TrialSite News reported, documents obtained by scientists through the Freedom of Information Act (FOIA) revealed pre-clinical studies showing the active part of the vaccine (mRNA-lipid nanoparticles) — which produce the spike protein — did not stay at the injection site and surrounding lymphoid tissue as scientists originally theorized, but spread widely throughout the body and accumulated in various organs, including the ovaries and spleen. Research suggests this could lead to the production of spike protein in unintended places, including the brain, ovaries and speen, which may cause the immune system to attack organs and tissues resulting in damage, and raises serious questions about genotoxicity and reproductive toxicity risks associated with the vaccine. Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario, who was awarded a $230,000 grant by the Canadian government last year for research on COVID vaccine development, said he and a group of international scientists filed a request for information from the Japanese regulatory agency to get access to Pfizer’s biodistribution study. The biodistribution study obtained by Bridle showed the COVID spike protein gets into the blood where it circulates for several days post-vaccination and then accumulates in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries. “We made a big mistake. We didn’t realize it until now,” said Bridle. “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” that could cause damage in our body if it gets into circulation.
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'We Made a Big Mistake' — COVID Vaccine Spike Protein Travels From Injection Site, Can Cause Organ Damage June 3, 2021 Research obtained by a group of scientists shows the COVID vaccine spike protein can travel from the injection site and accumulate in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries. COVID vaccine researchers had previously assumed mRNA COVID vaccines would behave like traditional vaccines. The vaccine’s spike protein — responsible for infection and its most severe symptoms — would remain mostly in the injection site at the shoulder muscle or local lymph nodes. But new research obtained by a group of scientists contradicts that theory, a Canadian cancer vaccine researcher said last week. “We made a big mistake. We didn’t realize it until now,” said Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario. “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. So by vaccinating people we are inadvertently inoculating them with a toxin.” Bridle, who was awarded a $230,000 grant by the Canadian government last year for research on COVID vaccine development, said he and a group of international scientists filed a request for information from the Japanese regulatory agency to get access to Pfizer’s “biodistribution study.” Biodistribution studies are used to determine where an injected compound travels in the body, and which tissues or organs it accumulates in. “It’s the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination,” Bridle said in an interview with Alex Pierson where he first disclosed the data. “Is it a safe assumption that it stays in the shoulder muscle? The short answer is: absolutely not. It’s very disconcerting.” The Sars-CoV-2 has a spike protein on its surface. That spike protein is what allows it to infect our bodies, Bridle explained. “That is why we have been using the spike protein in our vaccines,” Bridle said. “The vaccines we’re using get the cells in our bodies to manufacture that protein. If we can mount an immune response against that protein, in theory we could prevent this virus from infecting the body. That is the theory behind the vaccine.” “However, when studying the severe COVID-19, […] heart problems, lots of problems with the cardiovascular system, bleeding and clotting, are all associated with COVID-19,” he added. “In doing that research, what has been discovered by the scientific community, the spike protein on its own is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation.” When the purified spike protein is injected into the blood of research animals, they experience damage to the cardiovascular system and the protein can cross the blood-brain barrier and cause damage to the brain, Bridle explained. The biodistribution study obtained by Bridle shows the COVID spike protein gets into the blood where it circulates for several days post-vaccination and then accumulates in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries. “We have known for a long time that the spike protein is a pathogenic protein, Bridle said. “It is a toxin. It can cause damage in our body if it gets into circulation.” A large number of studies have shown the most severe effects of SARS-CoV-2, the virus that causes COVID, such as blood clotting and bleeding, are due to the effects of the spike protein of the virus itself. A recent study in Clinical and Infectious Diseases led by researchers at Brigham and Women’s Hospital and the Harvard Medical School measured longitudinal plasma samples collected from 13 recipients of the Moderna vaccine 1 and 29 days after the first dose and 1-28 days after the second dose. Out of these individuals, 11 had detectable levels of SARS-CoV-2 protein in blood plasma as early as one day after the first vaccine dose, including three who had detectable levels of spike protein. A “subunit” protein called S1, part of the spike protein, was also detected. Spike protein was detected an average of 15 days after the first injection, and one patient had spike protein detectable on day 29 — one day after a second vaccine dose — which disappeared two days later. The results showed S1 antigen production after the initial vaccination can be detected by day one and is present beyond the injection site and the associated regional lymph nodes. Assuming an average adult blood volume of approximately 5 liters, this corresponds to peak levels of approximately 0.3 micrograms of circulating free antigen for a vaccine designed only to express membrane-anchored antigen. In a study published in Nature Neuroscience, lab animals injected with purified spike protein into their bloodstream developed cardiovascular problems. The spike protein also crossed the blood-brain barrier and caused damage to the brain. It was a grave mistake to believe the spike protein would not escape into the blood circulation, according to Bridle. “Now, we have clear-cut evidence that the vaccines that make the cells in our deltoid muscles manufacture this protein — that the vaccine itself, plus the protein — gets into blood circulation,” he said. Bridle said the scientific community has discovered the spike protein, on its own, is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation. Once in circulation, the spike protein can attach to specific ACE2 receptors that are on blood platelets and the cells that line blood vessels, Bridle said. “When that happens it can do one of two things. It can either cause platelets to clump, and that can lead to clotting — that’s exactly why we’ve been seeing clotting disorders associated with these vaccines. It can also lead to bleeding,” he added. Both clotting and bleeding are associated with vaccine-induced thrombotic thrombocytopenia (VITT). Bridle also said the spike protein in circulation would explain recently reported heart problems in vaccinated teens. Stephanie Seneff, senior research scientists at Massachusetts Institute of Technology, said it is now clear vaccine content is being delivered to the spleen and the glands, including the ovaries and the adrenal glands, and is being shed into the medium and then eventually reaches the bloodstream causing systemic damage. “ACE2 receptors are common in the heart and brain,” she added. “And this is how the spike protein causes cardiovascular and cognitive problems.” Dr. J. Patrick Whelan, a pediatric rheumatologist, warned the U.S. Food and Drug Administration (FDA) in December mRNA vaccines could cause microvascular injury to the brain, heart, liver and kidneys in ways not assessed in safety trials. In a public submission, Whelan sought to alert the FDA to the potential for vaccines designed to create immunity to the SARS-CoV-2 spike protein to instead cause injuries. Whelan was concerned the mRNA vaccine technology utilized by Pfizer and Moderna had “the potential to cause microvascular injury (inflammation and small blood clots called microthrombi) to the brain, heart, liver and kidneys in ways that were not assessed in the safety trials.”
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Firefighters Denied Coverage by Veterans Affairs After Exposure to PFAS Firefighting Foam June 5, 2021 The VA and insurers have rejected claims from firefighters despite evidence linking PFAS foam and disease. When Kevin Ferrara was starting out in the Air Force in 1991, he and his fellow firefighters developed a method for cooling each other down. His training at Chanute Air Force Base in Illinois involved repeatedly putting jet fuel and other chemicals and debris into a pit, setting them on fire, and then putting the flames out with firefighting foam known as AFFF. Ferrara and the other members of the fire crew became unbearably hot as they stood around the fiery pit. For relief, they would cover each other with foam. “As we’re spraying each other, the substance would find its way under our collars and the cuffs of our sleeves. It would penetrate through the weak points of our suits,” Ferrara remembered. The sudsy foam did cool them down. Now, years later, Ferrara and many other civilian and military firefighters who were exposed to firefighting foam that contained the industrial chemicals known as PFAS are developing health problems that they believe are related to those occupational exposures. And despite ample evidence connecting PFAS exposure to multiple diseases, many are finding it difficult to convince others of the connection. While almost everyone has PFAS in their blood through exposure to water, dust and everyday products that contain the chemicals, firefighters may have greater contact with PFAS than any other group of workers. In addition to using — and often getting doused with — AFFF, it has become clear in recent years that the clothing that was supposed to protect them while fighting fires, known as turnout gear, is also saturated with PFAS. Given the frequent contact with the toxic chemicals, which accumulate in the body and cause kidney cancer, depressed immune function, and elevated cholesterol, among other health problems, it may not be surprising that firefighters have both relatively high levels of the chemicals in their blood and elevated rates of cancer diagnoses. Firefighters also have a death rate from cancers that is 14 percent higher than that of the general population, according to a study by the National Institute of Occupational Safety and Health. But some firefighters who have used AFFF now find themselves struggling not just with illnesses linked to the chemical-laden foam and firefighting gear, but also with getting coverage for benefits related to those illnesses. In April, Volunteer Firemen’s Insurance Services, a company that provides insurance and other services to firefighters and is a division of the Glatfelter Insurance Group, sent its policyholders a notice that the company would be applying a “pollution exclusion” to its coverage, specifying that “the application of the pollution exclusion is extended to any use of Class B firefighting foam containing PFAS.” The Glatfelter Insurance Group declined to answer questions for this story about how many firefighters and former firefighters are subject to its new pollution rider, which types of policies are affected, and why the company has chosen to exclude coverage of AFFF-related claims. Meanwhile, some former military firefighters who used the firefighting foam and wore the gear are struggling to get the Department of Veterans Affairs to recognize a connection between their workplace exposure and their illnesses. Ferrara, who has elevated triglyceride levels in his blood, Type 2 diabetes, and numbness in his feet and hands, all symptoms that he believes are related to his exposure to the chemicals while in the military, was unable to get the VA to pay for a blood test to measure the PFAS levels in his blood. The VA also denied his claim for disability benefits based on his exposure to the firefighting foam. Ferrara found that he wasn’t alone in meeting resistance from the hulking bureaucracy that provides health care to U.S veterans. As he learned more about the dangers of the foam that he had been told was harmless, he has become outspoken on the issue of the government’s obligation to take care of firefighters who were exposed to the chemicals in the line of duty. Through a Facebook group and email, he estimates that he has connected with at least 50 veterans who have developed cancer and other serious illnesses after using AFFF in the military and have had their claims for disability related to AFFF exposure denied by the VA. The VA provides these monetary benefits to veterans only if they can prove that an illness or injury was caused or exacerbated by their service. “The VA keeps pushing back, saying that since about 96 or so percent of Americans have PFAS in their blood, there’s no definitive correlation between AFFF and their medical illnesses,” said Ferrara. “But if you ask any firefighter, they’re going to tell you that’s BS.”
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Pfizer Skipped Critical Testing and Cut Corners on Quality Standards, Documents Reveal June 3, 2021 New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer COVID vaccine. New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer/BioNTech COVID vaccine, and that U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine. Regulatory documents revealed Pfizer didn’t thoroughly examine biodistribution and pharmacokinetics issues relating to its vaccine before submitting the vaccine to the European Medicines Agency (EMA) for review. In fact, in key studies — called biodistribution studies, which are designed to test where an injected compound travels in the body, and which tissues or organs it accumulates in — Pfizer did not use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA that produced the luciferase protein. According to TrialSite News, the EMA reviewers shared this explicit admission: “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Pharmacokinetics refers to the study of what the body does with a drug and the drug’s movement throughout the body — the time course of its absorption, bioavailability, distribution, metabolism and excretion. Regulatory documents also show Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies of its vaccine, as key studies did not meet good laboratory practice (GLP). Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies used as the basis for research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. “The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on the pressures of the pandemic,” said TrialSite founder and CEO Daniel O’Connor. “The challenge is that the processes, such as Good Laboratory Practices, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling.” O’Connor pointed to the example of generic repurposed drugs that when under evaluation, even if they are approved, must go through “ever more studies to prove their worth.” Yet in the case of the Pfizer vaccine, O’Connor said, “Pfizer was given more discretion even with a radically new life science-based technology.” According to TrialSite News, it’s standard practice for the EMA to disclose its assessment of investigational new drug submissions. In the case of Pfizer’s vaccine, the EMA assessment included a summary of the agency’s evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer — but the EMA did not disclose the results of Pfizer’s biodistribution studies in its public EMA summary. Studies submitted to the EMA were carried out using two methods: use of mRNA that produces the luciferase protein and use of a radioactive label to mark the mRNA. The studies revealed the majority of radioactivity initially remained near the injection site. But within hours, a subset of the stabilized mRNA-containing particles became widely distributed throughout the bodies of test animals. Rapporteur Filip Josephson, (a person appointed by an organization to report on the proceedings of its meetings) and Co-Rapporteur Jean-Michael Race suggested Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies performed and submitted by Pfizer were non-GLP. 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. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern.” This EMA observation corresponds with a growing number of adverse events and aligns with data TrialSite obtained through FOIA showing concentrations of LNP-formulated RNAs in the spleen, ovaries, other tissues and organs. TrialSite News contacted Dr. Robert W. Malone, the original inventor of mRNA vaccine technology and a senior regulatory specialist who serves as president of a prestigious European association who wished to remain anonymous. When asked to review and comment on the EMA assessment, Malone noted normal pharmacokinetic and pharmaco-toxicology studies had not been performed before EUA authorization for the product. “I was particularly surprised that the dossier of regulatory documents indicates allowance for use in humans based on non-GLP PK and Tox studies relying on formulations which are significantly different from the final vaccine,“ Malone said. After completing a review, TrialSite’s other source noted the following: “A quick review the Toxicology Section (2.3.3) of the European Medicines Agency (EMA) Assessment Report on Comirnaty (COVID-19 mRNA vaccine) issued on 19 February 2021, raises concerns about data applicability of preclinical study findings to clinical use: “To determine the biodistribution of the LNP-formulated modified mRNA (modRNA), the applicant did study distribution of the modRNA in two different non-GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA. “Thus, one might question the validity and applicability of non-GLP studies conducted using a variant of the subject mRNA vaccine. “In addition, no genotoxicity data were provided to EMA.” According to official government accounts, minimal risk is associated with COVID vaccines when compared to the risks of COVID infection. This belief forms the basis of the U.S. Food and Drug Administration’s Emergency Use Authorization approval, which is based on a risk-benefit analysis. However, a search in the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System (VAERS) revealed 294,801 reports of adverse events following COVID vaccines, including 5,165 deaths and 25,359 serious injuries between Dec. 14, 2020 and May 28, 2021. Though the U.S. government argues none of the deaths have been formally linked to COVID vaccines and the reported adverse event risk is low, the discovery of these documents and associated information may alter the risk-benefit assessment underlying the EUA decision, TrialSite News reported. As The Defender and TrialSite News reported, documents obtained by scientists through the Freedom of Information Act (FOIA) revealed pre-clinical studies showing the active part of the vaccine (mRNA-lipid nanoparticles) — which produce the spike protein — did not stay at the injection site and surrounding lymphoid tissue as scientists originally theorized, but spread widely throughout the body and accumulated in various organs, including the ovaries and spleen. Research suggests this could lead to the production of spike protein in unintended places, including the brain, ovaries and speen, which may cause the immune system to attack organs and tissues resulting in damage, and raises serious questions about genotoxicity and reproductive toxicity risks associated with the vaccine. Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario, who was awarded a $230,000 grant by the Canadian government last year for research on COVID vaccine development, said he and a group of international scientists filed a request for information from the Japanese regulatory agency to get access to Pfizer’s biodistribution study. The biodistribution study obtained by Bridle showed the COVID spike protein gets into the blood where it circulates for several days post-vaccination and then accumulates in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries. “We made a big mistake. We didn’t realize it until now,” said Bridle. “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” that could cause damage in our body if it gets into circulation.
14 views ·
'We Made a Big Mistake' — COVID Vaccine Spike Protein Travels From Injection Site, Can Cause Organ Damage June 3, 2021 Research obtained by a group of scientists shows the COVID vaccine spike protein can travel from the injection site and accumulate in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries. COVID vaccine researchers had previously assumed mRNA COVID vaccines would behave like traditional vaccines. The vaccine’s spike protein — responsible for infection and its most severe symptoms — would remain mostly in the injection site at the shoulder muscle or local lymph nodes. But new research obtained by a group of scientists contradicts that theory, a Canadian cancer vaccine researcher said last week. “We made a big mistake. We didn’t realize it until now,” said Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario. “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. So by vaccinating people we are inadvertently inoculating them with a toxin.” Bridle, who was awarded a $230,000 grant by the Canadian government last year for research on COVID vaccine development, said he and a group of international scientists filed a request for information from the Japanese regulatory agency to get access to Pfizer’s “biodistribution study.” Biodistribution studies are used to determine where an injected compound travels in the body, and which tissues or organs it accumulates in. “It’s the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination,” Bridle said in an interview with Alex Pierson where he first disclosed the data. “Is it a safe assumption that it stays in the shoulder muscle? The short answer is: absolutely not. It’s very disconcerting.” The Sars-CoV-2 has a spike protein on its surface. That spike protein is what allows it to infect our bodies, Bridle explained. “That is why we have been using the spike protein in our vaccines,” Bridle said. “The vaccines we’re using get the cells in our bodies to manufacture that protein. If we can mount an immune response against that protein, in theory we could prevent this virus from infecting the body. That is the theory behind the vaccine.” “However, when studying the severe COVID-19, […] heart problems, lots of problems with the cardiovascular system, bleeding and clotting, are all associated with COVID-19,” he added. “In doing that research, what has been discovered by the scientific community, the spike protein on its own is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation.” When the purified spike protein is injected into the blood of research animals, they experience damage to the cardiovascular system and the protein can cross the blood-brain barrier and cause damage to the brain, Bridle explained. The biodistribution study obtained by Bridle shows the COVID spike protein gets into the blood where it circulates for several days post-vaccination and then accumulates in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries. “We have known for a long time that the spike protein is a pathogenic protein, Bridle said. “It is a toxin. It can cause damage in our body if it gets into circulation.” A large number of studies have shown the most severe effects of SARS-CoV-2, the virus that causes COVID, such as blood clotting and bleeding, are due to the effects of the spike protein of the virus itself. A recent study in Clinical and Infectious Diseases led by researchers at Brigham and Women’s Hospital and the Harvard Medical School measured longitudinal plasma samples collected from 13 recipients of the Moderna vaccine 1 and 29 days after the first dose and 1-28 days after the second dose. Out of these individuals, 11 had detectable levels of SARS-CoV-2 protein in blood plasma as early as one day after the first vaccine dose, including three who had detectable levels of spike protein. A “subunit” protein called S1, part of the spike protein, was also detected. Spike protein was detected an average of 15 days after the first injection, and one patient had spike protein detectable on day 29 — one day after a second vaccine dose — which disappeared two days later. The results showed S1 antigen production after the initial vaccination can be detected by day one and is present beyond the injection site and the associated regional lymph nodes. Assuming an average adult blood volume of approximately 5 liters, this corresponds to peak levels of approximately 0.3 micrograms of circulating free antigen for a vaccine designed only to express membrane-anchored antigen. In a study published in Nature Neuroscience, lab animals injected with purified spike protein into their bloodstream developed cardiovascular problems. The spike protein also crossed the blood-brain barrier and caused damage to the brain. It was a grave mistake to believe the spike protein would not escape into the blood circulation, according to Bridle. “Now, we have clear-cut evidence that the vaccines that make the cells in our deltoid muscles manufacture this protein — that the vaccine itself, plus the protein — gets into blood circulation,” he said. Bridle said the scientific community has discovered the spike protein, on its own, is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation. Once in circulation, the spike protein can attach to specific ACE2 receptors that are on blood platelets and the cells that line blood vessels, Bridle said. “When that happens it can do one of two things. It can either cause platelets to clump, and that can lead to clotting — that’s exactly why we’ve been seeing clotting disorders associated with these vaccines. It can also lead to bleeding,” he added. Both clotting and bleeding are associated with vaccine-induced thrombotic thrombocytopenia (VITT). Bridle also said the spike protein in circulation would explain recently reported heart problems in vaccinated teens. Stephanie Seneff, senior research scientists at Massachusetts Institute of Technology, said it is now clear vaccine content is being delivered to the spleen and the glands, including the ovaries and the adrenal glands, and is being shed into the medium and then eventually reaches the bloodstream causing systemic damage. “ACE2 receptors are common in the heart and brain,” she added. “And this is how the spike protein causes cardiovascular and cognitive problems.” Dr. J. Patrick Whelan, a pediatric rheumatologist, warned the U.S. Food and Drug Administration (FDA) in December mRNA vaccines could cause microvascular injury to the brain, heart, liver and kidneys in ways not assessed in safety trials. In a public submission, Whelan sought to alert the FDA to the potential for vaccines designed to create immunity to the SARS-CoV-2 spike protein to instead cause injuries. Whelan was concerned the mRNA vaccine technology utilized by Pfizer and Moderna had “the potential to cause microvascular injury (inflammation and small blood clots called microthrombi) to the brain, heart, liver and kidneys in ways that were not assessed in the safety trials.”
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