New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer COVID vaccine.
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.
“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 CEO Daniel O’Connor. “The challenge is that the processes, such as Good Laboratory Practices, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling.”
O’Connor pointed to the example of generic repurposed drugs that when under evaluation, even if they are approved, must go through “ever more studies to prove their worth.” Yet in the case of the Pfizer vaccine, O’Connor said, “Pfizer was given more discretion even with a radically new life science-based technology.”
According to TrialSite News, it’s standard practice for the EMA to disclose its assessment of investigational new drug submissions. In the case of Pfizer’s vaccine, the EMA assessment included a summary of the agency’s evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer — but the EMA did not disclose the results of Pfizer’s biodistribution studies in its public EMA summary.
Studies submitted to the EMA were carried out using two methods: use of mRNA that produces the luciferase protein and use of a radioactive label to mark the mRNA.
The studies revealed the majority of radioactivity initially remained near the injection site. But within hours, a subset of the stabilized mRNA-containing particles became widely distributed throughout the bodies of test animals.
Rapporteur Filip Josephson, (a person appointed by an organizationto report on the proceedings of its meetings) and Co-Rapporteur Jean-Michael Race suggested Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.”
However, the studies performed and submitted by Pfizer 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 a growing number of adverse events and aligns with data TrialSite obtained through FOIA showing concentrations of LNP-formulated RNAs in the spleen, ovaries, other tissues and organs.
