Partners and supporters,
also for the 2020-2021 season we have decided to present a general program of actions that we will develop in the next two years, to explain the furrows traced and where we want to go. We can summarize the projects into four main categories, which are:
- Legal area
- Projects related to the vaccine quality survey
The first three battle areas will focus on raising awareness of the population on the issue of freedom of choice in the therapeutic field, on providing concrete help to members, on defining points that contrast the authoritarianism in the scientific and health fields of recent years, and many are the examples with which Corvelva over the years has pressed on these focuses:
- for Communication: from events, to the purchase of newspaper pages and / or billboards / sailing trucks / posters; the development and maintenance of a functional website that has led the views to grow exponentially all over the world (enough to lead us to implement the sections in English); the creation and free distribution of leaflets; the interviews given on the various topics, the organization of conferences and opportunities for further study, etc.
- for the Legal Area: requests for access to documents (Foia), warnings (free for members in 2017 and 2018) aimed at the school situation; drafting of vademecum, legal opinions and iter for objection ASL, exposed-complaints (also on specific statements by institutional and non-institutional figures, concerning the safety of vaccines and the existence of the damages related to them, as well as on the results of the analysis project), assistance to victims of vaccine in the administrative and judicial phases, etc.
- for Research: financing of studies and publications of different nature with maximum openness to integrate the strategy on related subjects but always falling within the freedom of choice. In previous years we have financed more than one publication, such as on the flu vaccine in collaboration with Dr. Franchi, commissioning and publication of a study on military health in collaboration with Cosmi and Ivan Catalano, start-up of the antibody analysis project that today was taken up by others, etc.
We cannot quantify the expenditure for each individual project in these areas of action, also because many start as a reaction to specific actions, such as warnings for school exclusions or awareness campaigns in conjunction with the appeal of the Veneto Region to the Constitutional Court, we will not draft therefore for these three areas of specific projects but our commitment will be to continue on the road already traveled, or to exploit all the resources in our possession where it will seem more urgent, necessary or useful.
We are instead able to give a rather precise indication of both the projects and the costs and times as regards the survey on the quality of the vaccines, as we have completed the first phase of work and have already determined therefore what the most important aspects may be interesting to investigate, in addition to obtaining approximate cost estimates. Of this you will find a detailed study in the next pages.
In addition to this, we are keen to continue to have a territorial office, inaugurated in 2018, through which we have been able to expand the topics treated and proposed to the associates and to all the people who want to approach the theme of Health, in addition to giving concrete assistance and direct, for example, through appointments, also individual for members and non-members; in addition, the venue was equipped in order to transmit and disseminate the most interesting videos of the meetings, free of charge, on the web.
It is obvious that all the activities described here will be possible only thanks to the support and support of those who believe in us: if you believe that our battle is yours, you can support it associating in Corvelva or making one donation.
Projects related to the vaccine quality survey
It is compulsorily divided into other sub-projects: we present them divided according to the analysis technologies chosen both for costs and because some insights are consequent to the work done in 2018/2019.
1.0. Next Generation Sequencing (NGS):
1.1. Completion of MRC-5 cell line sequencing. This cell line is the main component of the Priorix Tetra vaccine and is widely used in several MPR vaccines marketed in Europe. We have analyzed the cell line present in the vaccine and commissioned a service provider to purchase the Mrc5 and compare it with that present in the vaccine. The result was positive, the cell line contained in the Priorix Tetra vaccine is MRC-5 and now we have confirmed, from our analyzes, that this line has numerous genetic translocations that seriously jeopardize its safety. The decision to analyze the original line would answer a clear question: do the "transformations" take place during the production phases or are the problems at the source, that is, precisely in the cell line itself as it is purchased for production?
Recall that the World Health Organization and especially the EMA do not currently place limits on the amount of DNA present in vaccines unless it comes from Vero cells or in any case from cell lines known to be tumorigenic. Going to study this cell line in depth helps us to be able to counterattack on the guidelines by demonstrating, or refuting, the safety of this component that contaminates the vaccine. From the data in our possession now, this line, the Mrc5, is potentially tumorigenic, that is, carcinogenic.
▪ TIMING: nearing completion
▪ COST: less than 1.000 €
1.2. Study of the quasi-species of the measles virus. In the report of the viral quasi-species contained in the lots of Priorix Tetra, we had given news of a series of "mutants" that were going to pose serious doubts about the effectiveness of these vaccines. We had left a parenthesis open since the quantity of viral measles material was so little that we could not identify its mutations with the technology used (NGS). Going to study this aspect in a sample for at least three different lots and in more vaccines, would give a very solid data to understand what people are immunizing against.
▪ TIMING: about 2-4 months since we commission the laboratories (i.e. since we supply all the vaccine samples)
▪ COST: 5.000 € approx.
2.0. Mass spectrometry (LC-MS)
2.1. Analysis with control standards. For each vaccine analyzed in 2018/19, a selection of two compounds was made and of these we had purchased the control standards in order to be sure of their presence.
Here we try to be as clear as possible, even coarse, leaving the technical aspect to the previous reports: mass spectrometry is able to identify the presence of a large number of chemical compounds in complex matrices and of these generates a number, the molecular weight, which if entered in the database can be associated with the compound. The larger the molecule, the more signals can be generated by the instrument, also giving more probable compounds associated with a given molecular weight. Some of these results are alarming; we are convinced that it is necessary to identify their presence with certainty, or by purchasing the relative certified control standard, in order to associate them with precision. The result, as in the case of APDB (amphetamine found in Gardasil9), could open up to a series of complaints / reports to NAS.
▪ TIMING: about two months since we commissioned the work from the labs
▪ COST: 2.000 € approx. for each control standard.
2.2. Interlaboratory analysis of the control standard - If point 2.1 is activated, to verify the data, it is mandatory to commission the analysis in a second laboratory so that the data is proven both by the control standard and by at least 2 different labs. In this case the cost of the standard is zero, since it is already purchased for primary analysis and is also used in the second laboratory, there is obviously the cost of the analysis itself.
▪ TIMING: about two months after the result of point 2.1
▪ COST: 1.000 € approx. for each control standard (additional to 2.1)
2.3. Study of the properties of the macromolecule found in the Infanrix hexa vaccine - In this vaccine we have found the presence of an insoluble and indigestible macromolecule. We would like to continue with the study of its composition by applying other specific methods to break up these types of aggregates. The primary purpose was to understand what is injected at the time of vaccination, now it is necessary to understand its properties more deeply.
The planned investigation would allow to evaluate its aggregating capacity in the presence of the native scrapie protein (mad cow prion). With this preliminary experiment we will try to understand: first, if it is possible to disaggregate the macromolecule in more aggressive conditions and study the individual components (antigens and protein contaminations) and second, if the macromolecule has prionic behavior or not.
▪ TIMING: about two months after the purchase of the control standards
▪ COST: 2500 €
2.4. Study of the power of the antigens of the Infanrix hexa - We have been hoping for this analysis for at least a year and have outlined what is necessary. Finally we are able to rely on accredited laboratories, outside Italy, able to perform an in vitro and in vivo study for us to verify the immunization capacity of the GSK hexavalent vaccine. This study aims to evaluate whether the Infanrix hexa is able to stimulate the production of antibodies against the 10 vaccine antigens compared to the control standards (single vaccine antigens and wild type antigens). The animals will only be used to carry out vaccinations and the collection of antibodies (the animals will not be suppressed or vivisected).
▪ TIMING: 6 months ca.
▪ COST: 13.000 €
2.5. Study of the power of the antigens of the Priorix Tetra - Operation identical to point 2.4 but on the quadrivalent Priorix Tetra vaccine.
▪ TIMING: 6 months ca.
▪ COST: 13.000 €
2.6. Study of prionic behavior (aggregating ability-formation of an insoluble precipitate) - If point 2.3 is successful, that is, it leads to a positive result for the prionic behavior, it is possible to confirm it.
We want to help understand this possible huge problem, namely the prionic behavior of some components of the vaccines analyzed, and to do this we have identified several technologies capable of giving us some answers on the subject. In this case, being a particularly complex analysis, we have identified an accredited international laboratory for these types of analyzes.
▪ TIMING: 2 months ca.
▪ COST: 10.000 € approx.
2.7. Complete screening of a new vaccine - We want to repeat the primary screening (2018/19) on other vaccines, for now we have identified a type of vaccine but the project can extend to others.
▪ TIMING: 2 months ca.
▪ COST: 5.000 € approx. as a maximum cost; if the vaccine, for example, does not require metagenomic analysis, the figure can be halved.
3.0. New publications
If the analyzes are important, the publication of the results in scientific peer-reviewed journals is equally important. We have (at the time of writing) two publications already in approval, one for chemical analyzes and one for metagenomic analyzes, concerning the methods, but a whole series of publications remain that would certainly bring the discussion to another plane. Below we list only some of our ideas and to protect the outcome we will remain vague but they should make us understand where we want to go:
New publications already drafting course: indefinite cost
- on the sequencing of the complete MRC-5 genome (already performed)
- on complete interlaboratory analyzes of genetic material (already performed)
On the program:
- prion study;
- study on quasispecies;
- review of the implications of vaccine quality control results
▪ TIMING: from 3 months to 1 year from the completion of the analyzes.
▪ COST: we have some estimates but the variables are indeterminable, the idea is to allocate an initial budget of € 10.000 for this project.