New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer COVID vaccine.
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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.