French drug assessment center demands removal of all four widely used CÖVÌD ναccιnєs
According to the CTIAP, all of the ναccιnєs were put on the market and actively used on human beings before ‘proof of
quality for the active substance and the finished product’ was produced.
Thu Apr 22, 2021 - 10:42 am ESTApril 22, 2021 (LifeSiteNews) — A regional independent drug assessment center, the CTIAP (Centre territorial d’Information indépendante et d’Avis pharmaceutiques), which is linked to the Cholet public hospital in the west of France, recently published a report showing that the ναccιnєs used against CÖVÌD were not only submitted to insufficient clinical testing, but that the quality of the active substances, their “excipients, some of which are new,” and the manufacturing processes are problematic. “These new excipients should be considered as new active substances,” the Cholet hospital team stated, in a study that according to them raises issues that have not been commented to date.The team led by Dr. Catherine Frade, a pharmacist, worked on public data released by the EMA with relation to the pfιzєr, mσdernα, AstraZeneca and Janssen (Johnson & Johnson) shots, and its first caveat was that all these products only have temporary marketing authorizations. They are all subject to further studies that reach as far as 2024 and even beyond, and these will be almost impossible to be completed because of the way the ναccιnєs are now being distributed, said the CTIAP report.These studies even include the stability and comparability of the ναccιnє batches put on the market and the quality and safety of excipients — substances formulated alongside the active ingredient of a medication to facilitate or enhance their absorption.According to the CTIAP, all of the ναccιnєs were put on the market and actively used on human beings before “proof of quality for the active substance and the finished product” was produced: all the manufacturing labs obtained future deadlines to submit their studies in this regard.The authors of the report consider that the “variabilities, which impact the very core of the product, could even invalidate any clinical trials conducted” in the coming months and years.They go so far as to state: “Prudence would even dictate that, in all countries where these ναccιnєs against CÖVÌD-19 have been marketed, all the batches thus ‘released’ should be withdrawn immediately; and that these MAs that have been granted should be suspended, or even canceled, as a matter of urgency until further notice.”Here below is LifeSite’s full working translation of the CTIAP’s April 2 report:Can we imagine launching a car manufacturing line and putting vehicles on the road, despite the uncertainties noted in the official docuмents published? These uncertainties are related to the quality of the parts making up the engine and the various other parts, including those related to safety, the manufacturing process, the reproducibility of the batches that are being marketed, etc.In the field of medicines (including ναccιnєs), the pharmaceutical act of “release” of the finished product (an authorized product intended for sale) constitutes the final stage of control that precedes the release of these products to the population. This key step of “release” is under the pharmaceutical responsibility of the manufacturers.Following its previous analyses, the CTIAP of the Cholet Hospital Center has once again revealed to the public, and probably in an unprecedented and exclusive way, new vital information concerning the following four ναccιnєs against CÖVÌD-19: the one from the BioNTech/pfιzєr laboratory; the one from the mσdernα laboratory; the one from the Astra Zeneca laboratory; the one from the Janssen laboratory.This work was made possible thanks to the valuable contribution of Dr. Catherine Frade, pharmacist and former director of international regulatory affairs in the pharmaceutical industry. She graciously provided us with a docuмented, written alert. In this docuмent, she sheds light on data extracted, on March 22, 2021, from the MA (marketing authorization) itself; an MA qualified as “conditional.” She has extracted “source data that is difficult to identify by someone who does not work in the field.” This data is therefore public and verifiable. First of all, it should be noted that the author of this docuмent no longer works in the pharmaceutical industry; she states: “First of all, I would like to make it clear that I have no conflict of interest with the pharmaceutical industry.” It is therefore with her agreement that CTIAP intends to make available to the public, health professionals, decision-makers … an analysis of some of these data that all should read carefully.This reflection first presents what a “conditional” MA is (I). Then, it recalls that the studies for these ναccιnєs are not complete, as they run from “2021 to at least 2024” (II). Then, it reveals, in an unprecedented and exclusive way, that the official docuмents, published by the European Medicines Agency (EMA), underline the insufficiency of the evidence concerning also the “quality” of the “active substance” and of the “excipients,” of the “manufacturing process,” of the “reproducibility of the batches” that are being commercialized, etc. (III). Finally, this analysis proposes a conclusion.I — First of all, it is important to understand what a “conditional” MA isAn MA is to a drug what a car registration docuмent is to a car. MA is granted when a drug has proven its quality, efficacy, and safety; with a positive benefit/risk ratio: that is, it presents more benefits than risks. Obtaining this MA is the essential condition for a pharmaceutical laboratory to sell any drug, including ναccιnєs.Here, in the case of these ναccιnєs against CÖVÌD-19, the four MAs issued are so-called “conditional” MAs. They are temporary. They are valid for no more than one year, because they were obtained on the basis of “incomplete data.” To obtain a standard 5-year MA, the laboratories concerned must provide dossiers completed with “studies in progress and studies planned for the coming years.” Throughout “this development,” close and coordinated monitoring between the manufacturing laboratories and the health authorities is organized through regular discussions. The “conditional” MA is “re-evaluated each year” according to the contribution and critical analysis of additional data provided and collected during a full year.This “conditional” MA is a European MA. It was obtained through the centralized accelerated procedure. It allows simultaneous marketing in the following 30 countries (European Union and European Free Trade Association): Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.The studies concerning these four ναccιnєs are therefore still in progress.II — Secondly, the planned studies are still in progress and are spread over a period ranging from “2021 to at least 2024”All of the studies submitted during the MA application are summarized in the EPAR (European Public Assessment Report). This report is published on the European Medicines Agency (EMA) website. The planned studies, not yet completed, are also included.This schedule, which “extends from 2021 to at least 2024,” depending on which CÖVÌD-19 ναccιnє is involved, is defined in the “annexes” of the conditional marketing authorization and in the published EPARs.As an example, the BioNTech/pfιzєr ναccιnє received this European conditional MA on December 21, 2020. And the deadline for filing “confirmation” of efficacy, safety, and tolerability of this ναccιnє is “December 2023.”The mσdernα ναccιnє was granted marketing authorization on January 6, 2021. The deadline for filing “confirmation” of efficacy, safety, and tolerability of the ναccιnє is “December 2022” at the earliest.AstraZeneca’s ναccιnє was granted marketing authorization on January 29, 2021. The deadline for filing “confirmation” of efficacy, safety, and tolerability of the ναccιnє is “March 2024.”The Janssen ναccιnє was granted conditional European marketing authorization on March 11, 2021. The deadline for submitting “confirmation” of the ναccιnє’s efficacy, safety and tolerance is “December 2023.”https://tinyurl.com/3tvr68pk
Topic: Drug Assessment Centre demands removal of all ναccιnєs (Read 258 times)