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...<<<Read The Full Article Here>>>...
