ISS "responds" to our requests for clarification relating to the chemical analyzes of Priorx Tetra

ISS "responds" to our requests for clarification relating to the chemical analyzes of Priorx Tetra

We report in full the email exchange between Corvelva and the Istituto Superiore di Sanità in relation to the recent chemical analyzes on the Priorix Tetra (here the link of the analyzes).


eMail Pec of Corvelva at the Istituto Superiore di Sanità (22 November 2018)

Request for information Study on the chemical composition profile Priorix Tetra

Updating our previously sent data (https://goo.gl/veW35T) on the metagenomic analysis of vaccines currently on the market (https://goo.gl/qBCMi7), we bring to your attention the preliminary results of the analysis of contaminants and of the chemical and protein impurities of the Priorix Tetra vaccine, found in the Italian territory.

This vaccine, as per the preliminary technical report attached, presents a significant number of contaminations and impurities of compounds partially identified through the databases.
Since the vaccine is registered at national level, but subject to European legislation, we ask to be able to view the guidelines adopted for the control of chemical and protein contaminations in the finished product and to know the criterion according to which the specifications for the limits are defined residuals of the substances found (known and unknown).

Regards
Ferdinando Donolato, President of Corvelva

Download: eMail Pec sent to the ISS


Reply eMail Pec of the Istituto Superiore di Sanità in Corvelva (22 December 2018)

SUBJECT: Corvelva - Request for information Study on the chemical composition profile Priorix Tetra

With reference to your request to be able to view the guidelines adopted for the control of chemical and protein contaminations in the finished product and to know the criterion on the basis of which the specifications are defined for the residual limits of the substances found (known and unknown), it is noted that this information is publicly available on the websites of international bodies. In particular, they are available on the public page of the EMA website https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines; the various guidelines provide harmonized indications in the European Community which define the criteria on the basis of which the quality, safety and efficacy requirements of the medicines (including vaccines) established by the EU directives are assessed and approved.

Furthermore, the quality of substances for pharmaceutical use, including vaccines, is established by the current texts of the European Pharmacopoeia of the Council of Europe (https://www.edqm.eu/european-pharmacopoeia-ph-eur-9th-edition), which can be purchased in paper and / or electronic format.

Finally, since the vaccines before being placed on the market are subjected, lot by lot, to an additional quality control by an Official European Laboratory for the Control of Medicines (OMCL), it is advisable to consult also the official website of the European Directorate for the Quality of Medicines (EDQM, https://www.edqm.eu/en/) which reports to the public the criteria applied in order to evaluate the quality of the individual lots before their use.

With best regards
The Director of the National Center for Drug Control and Evaluation Dr. Carlo Pini

Download: eMail Pec reply to Corvelva


Corvelva's reply to the ISS's latest eMail Pec

Subject: Reply to your Prot. Gen. ISS n. AOO-ISS 21/12/2018 0038820

To the kind attention of the Director of the National Center for Drug Control and Evaluation, Dr. Carlo Pini

Thanking you for your kind reply, we inform you that Ema had already given us feedback in August 2018. The answer is available here https://goo.gl/LDMNoX.

Among other things, moreover, EMA pointed out that in reference to the Priorix Tetra, specifically, the answers had to be requested precisely from your institution: cit. "In reference to the Priorix Tetra, Vivotif, and Measles Live Vaccine BP, these are vaccines with release of the marketing authorization in the member countries through the national authorization procedure and not via EMA, if you want to obtain further information on the vaccines authorized at national level you should contact the national competent authority in the state of your interest. "

Without this premise, we inform you that we have already consulted the sites you have recommended and that we have not found what you requested; furthermore, there are no specific studies on the implications of the quantities of fetal DNA found.

These cell lines found in non-negligible quantities, according to the EMA response, are "considered" safe, but there are no specific studies in this regard or at least we are not in possession of them or are present in the documentation indicated by you.

In general, however, in reference to your response that "before being placed on the market, the vaccines are subjected, lot by lot, to an additional quality control by an Official Laboratory (OMCL)", once again we are forced to reiterate that our requests refer to various substances found within the vaccines themselves, which are not necessarily part of those controlled by default, and therefore it would seem appropriate to investigate what we have exposed.

Do the controls carried out by OMCL Laboratories establish below which threshold the presence of fetal cells with high molecular weight can be considered compliant? Do the checks carried out search for the presence of contaminants, also different from those foreseen in the guidelines?

Using methods other than those defined by the European Community for the evaluation and approval of the quality, safety and efficacy requirements of medicinal products, various chemical and biological substances have been identified and on which there are no specific regulations; the existence of these results has been brought to your knowledge, we believe that we have done everything in our power: our request for answers from the various Control Bodies is part of the duties of civil society, when doubts arise (supported by data) on the safety of certain preparations - drugs or vaccines that are - on the market.

On the other hand, it is not a mystery to anyone that it could happen, and it happened, that drugs or vaccines were withdrawn from the market (even after several years from the placing on the market) due to the presence of impurities or contaminations, as well as new profiles of risk emerged after the control bodies had already fulfilled their task and authorized the medicinal product for placing on the market. The reports often come from the manufacturer, therefore it is clear that there may be risk profiles that are not identified by the routine control analyzes. By way of example, the withdrawal of various batches of the "Meningitec" vaccine in 2014 is due to the "presence of a reddish orange foreign body identified as iron oxide and stainless steel". These lots were commercially available and were used and administered.

Cases like this demonstrate, if needed, that "batch by batch" checks may not be sufficient to guarantee the safety of the product from all points of view, simply because, of course, they do not include any analysis method and they do not seek every type of substance or possible contamination, but only those indicated, precisely, in the guidelines.

For this reason, it seemed to us an act due to inform you of the results of the analyzes we commissioned, obviously we cannot replace you and your task, therefore the assessments as to whether or not to investigate these reports remain your responsibility.

Our Association filed a complaint with the Public Prosecutor of the Republic of Rome in August 2018, when we obtained the first results (also of these previous analyzes we made you aware with Pec email of 9 July 2018 at 16:03 available here https://goo.gl/VAzyPy ). The same will be integrated with the latest findings from subsequent analyzes carried out, which raise other doubts and new questions regarding the safety of these vaccines.

We thank you for the answer, we trust as always in your role in defense of public health and for this reason we will continue to update you on any problems that we may encounter.

Regards
Ferdinando Donolato, President of Corvelva

Download: eMail Pec response to ISS