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EXPOSED: New Documents Reveal Pfizer Skipped Critical Safety Checks Before EUA of Experimental COVID-19 Vaccine


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When Big Pharma’s profits come before public safety, there’s bound to be important safety checks that get bypassed.

Since vaccine manufacturers have zero legal liability for vaccine-related injuries/deaths, there’s no reason for them to care about safety.

In the case of the experimental COVID-19 vaccines, the unprecedented number of VAERS Report cases should lead to an immediate halt of their distribution.

As previously reported, the latest VAERS Report noted over 5,000 post-vaccine deaths and nearly 4,000 cases of permanent injuries.

The horrific and often life-threatening side effects have led to more questions than answers regarding the risk-benefit analysis of the experimental jabs.

As noted by Dr. Byram Bridle, shocking discoveries about the experimental jabs show that the spike protein can spread throughout the body and accumulate in organs, notably the ovaries and spleen.

And newly retrieved regulatory documents indicate Pfizer either skipped or failed to thoroughly analyze key biodistribution studies before submitting the experimental jab for review.

Pfizer’s lackadaisical review failed to meet industry standards and study how the vaccine moves throughout the body.

And one can argue this failure (whether caused by corruption or incompetence) has resulted in the record-breaking number of vaccine-related injuries.

But when greed runs the pharmaceutical industry and effective therapeutics are censored, this shouldn’t shock the public.

TrialSite News shared this info:

TrialSite has learned of material information regarding mRNA vaccine safety revealed by a freedom of information act (FOIA) request filed by a group of Canadian physicians. These doctors have become concerned about COVID-19 mRNA vaccine safety. This new safety information involves the Pfizer mRNA-based vaccine known as BNT162b2 or “Comirnaty.” The FOIA documents reveal animal study results demonstrating that the Pfizer mRNA-based vaccine does not remain at the injection site, but rather appears to spread widely after injection. According to the documents, pre-clinical studies show that the active part of the vaccine (mRNA-lipid nanoparticles), which produce the spike protein, spreads throughout the body and is then concentrated in various organs, including the ovaries and spleen. The FOIA-produced data sets are incomplete, so the full meaning of these data cannot be determined at this time. TrialSite has also learned via regulatory documents that apparently (at least in their European Medicines Agency submission), Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies during vaccines, as key studies did not meet good laboratory practice (GLP). The full panel of industry-standard reproductive toxicity and genotoxicity studies were apparently also not performed. But does this matter in light of the risk-benefit analysis associated with regulatory emergency use authorization (EUA)?

Recently, there has been speculation regarding potential safety signals associated with COVID-19 mRNA vaccines.  Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. Women have reported changes in menstruation after taking mRNA vaccines. Problems with blood clotting (coagulation) – which are also common during COVID-19 disease – are also reported.

Among the most critical tests, which must be performed prior to testing any drug or vaccines in a human being, is whether it can cause mutations in the DNA (genotoxicity), or whether it could cause problems with cells or tissues of the reproductive tract – including ovaries (reproductive toxicity). In the case of the Pfizer COVID mRNA vaccine, these newly revealed documents raise additional questions about both the genotoxicity and reproductive toxicity risks of this product. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. Furthermore, in key studies designed to test whether the vaccine remains near the injection site or travels throughout the body, Pfizer did not even use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA producing the luciferase protein.

These new disclosures seem to indicate that the U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine. It is certainly understandable why the vaccine was rushed into use as an experimental product under emergency use authority, but these new findings suggest that routine quality testing issues were overlooked in the rush to authorize use. People are now receiving injections with an mRNA gene therapy-based vaccine, which produces the SARS-CoV-2 spike protein in their cells, and the vaccine may be also delivering the mRNA and producing spike protein in unintended organs and tissues (which may include ovaries). Unfortunately, there is no way to know if this is related to vaccine safety signals or reports of menstrual irregularities; the required studies were either not done or not done properly.

TrialSite News also discussed the European Medicines Agency (EMA) assessment of the experimental Pfizer jab:

As standard practice, the European Medicines Agency (EMA) discloses their assessment of investigational new drug (IND) submissions. In the case of the Pfizer-BioNTech “Comirnaty” vaccine, the EMA assessment can be found on the Web here. This document includes a summary of EMAs evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer-BioNTech. These studies were carried out using two methods: 1) use of mRNA producing the luciferase protein and 2) use of radioactive label to mark the mRNA (a more sensitive approach). These studies reveal that the majority of radioactivity initially remains near the injection site. However, within hours, a subset of the stabilized mRNA-containing particles become widely distributed throughout the bodies of test animals.

Upon inspection of the EMA summary document, TrialSite found evidence suggesting that the issue of biodistribution and pharmacokinetics of the “Comirnaty” BNT162b2 vaccine was not thoroughly examined in accordance with industry norms prior to the EMA review of the BNT162b2 IND/CTD. The reviewers share an explicit admission that “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Rapporteur (Filip Josephson) and Co-Rapporteur (Jean-Michael Race) suggest, however, that Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and suggest that “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies that were performed and submitted 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 what appears to be a growing number of adverse events and aligns with data TrialSite observed via the FOIA showing concentrations of LNP-formulated RNAs in the spleen, for example.

To obtain independent reviews of these EMA regulatory documents, TrialSite contacted both Dr. Robert W. Malone, MD, MS, and another expert that wished to remain anonymous, and provided them copies of the EMA analysis and the FOIA documents. Dr. Malone was the original inventor of the mRNA vaccine technology back in the late 1980s. He currently advises several companies in regulatory affairs and clinical development. One of TrialSite’s other sources is a senior regulatory specialist who currently serves as the President of a prestigious European association.  When asked to review and comment on the EMA assessment, Dr. Malone noted that 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.“ 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.”

Based on the FOIA documents, the biodistribution results (which are not disclosed in the public EMA summary document) suggest that the delivery technology results in mRNA delivery and significant concentration of the delivery lipids in ovaries, spleen, and other tissues and organs.



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