Information obtained by Trial Site News reveals that routine quality testing issues were overlooked in the rush to authorise the use of the Pfizer/BioNTech COVID-19 vaccine and that governments around the globe, including the US and UK government, conducting a massive vaccination program with a completely experimental vaccine.
The documents appeared to show that Pfizer did not thoroughly investigate the biodistribution and pharmacokinetics of its vaccine before submitting it to the European Medicines Agency (EMA) for review.
In key studies – known as biodistribution studies, which are designed to determine where an injected compound travels within the body, and which tissues or organs it accumulates in – Pfizer did not use the commercial vaccine (BNT162b2) but instead used a surrogate mRNA that produced the luciferase protein.
The EMA reviewers even shared an explicit admission that: “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.”
Pharmacokinetics refers to how the body uses a drug, what it does with it, and how the drug travels through the body. This involves the time course of its absorption, bioavailability, distribution, metabolism, and excretion.
According to Trial Site News, regulatory documents show that Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies during vaccines, as key studies failed to meet good laboratory practice (GLP).
Good Laboratory Practice or GLP is the quality system that is concerned with the quality and integrity of non-clinical studies. It aims to “ensure the consistency, reliability, uniformity, and quality of chemical non-clinical safety tests.” GLP is most commonly associated with the pharmaceutical industry and non-clinical animal testing that must be performed before new drug products can be approved.
Additionally, the full panel of industry-standard reproductive toxicity and genotoxicity studies were not performed.
TrialSite founder and CEO Daniel O’Connor, said: “The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on the pressures of the pandemic.
“The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on the pressures of the pandemic.”
O’Connor said that in the case of the Pfizer vaccine, Pfizer was “given more discretion even with a radically new life-science based technology.”
When new drugs are submitted, it is standard for the EMA to disclose its assessment, however, in the case of the Pfizer vaccine, the EMA did not disclose the results of Pfizer’s biodistribution studies in its public EMA summary.
One of TrialSite’s sources 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.”
With the vaccine rollout in full swing across the globe and children set to be vaccinated as early as August, it appears as though big pharma corporations such as Pfizer, Moderna, and co. have managed to rush through a completely experimental jab, which in the case of Pfizer, has not undergone industry-standard quality tests.
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