This is it! We are pleased to inform you Corvelva has pre-published the analysis methods of recent metagenomic tests.

For almost one year Corvelva has been focusing on different vaccine samples analysis, and the first data recently published show the presence of genetic material in some vaccines currently on the market, analyzed by NGS (next generation sequencing also known as deep sequencing), a pioneering sequencing method which makes it possible to trace the whole sequence of viral DNA and RNA genomes and bacterial genomes existing in the sample and compare it with the baseline genomes in public databases.

That said, we had set different goals to our project; naturally our first goal was to verify the analyzed vaccines compliance, and furthermore, the way we like, to make our analysis available to everyone, not just for the results but also for methods and replicability.

Thanks to this disclosure, the method for sequencing genetic material eventually existing in vaccines as impurity is made public, so that anybody will be allowed to ask any equipped laboratory for deep sequencing to replicate the analysis. We assure you that compared to 5 years ago, the technology for deep genetic sequencing " can nowadays be easily available.

This enables everyone, anywhere in the world, to become a scrutiny body without having to invest a considerable amount of money to refine the extractive methodology. Corvelva has been waiting for months before being able to release the first results and funded some laboratories in order to work just on this.

It is for us a really important achievement, regardless of the content of the publication, extremely technical and strictly focused on methods thus not suitable for descriptive or general purposes other than our cause, however this step takes our fight onto the nextlevel: from Melbourne to Rome, anyone will independently be able to verify the genetic material existing in any vaccine.

In the recent article pre-published on F1000research “Do you cov me? Effect of coverage reduction on species identification and genome reconstruction in complex biological matrices by metagenome shotgun high-throughput sequencing” NGS technology has been used to analyze biological matrices of different kinds, including the two analyzed batches of MPRV (Priorix Tetra), in order to prove the ability of this system to typify the biological component in a complex matrix.

There are two further scientific publications showing how , through NGS, it has been possible to prove the causal connection between the damage and the vaccine sample: this can now be verified in an independent way and demonstrated in the appropriate forums.

Indeed, this issue is vital to us: law 210/1992 in Italy is by now a pipe dream, an obstacle course made of obstructionism, denial and bureaucracy. Now we'll all have an additional instrument for fighting and, in perspective, it'll be possible to shift the paradigm of compensation for the damages, providing evidence that the cause and the consequent compensation is chargeable to the drug-vaccine producer itself. There will be lots of work to do on this, but the present publication is just the first step in this direction, and we will not stop.

Returning to the pre-published article on F1000research, it can be seen how about 80% of the sequences obtained by NGS technology on the two vaccine samples, consists of human DNA, as impurity present during the production process; we already published on our website the analysis certificates of the seven examined samples and it turns out that the total amount of foreign DNA in Priorix Tetra is not residual and is approximately 2 micrograms deriving from the human fetal cell line MRC-5 used to grow rubella and varicella viruses. This finding confirms the researches carried out by "Epidemiologic and Molecular Relationship Between Vaccine Manufacture and Autism Spectrum Disorder Prevalence".

It should be noticed that Dr. T. Deisher has preliminarily demonstrated that fetal DNA presents safety problems, since it can give rise to recombination with the host's genomic DNA, a mechanism responsible for carcinogenesis and auto-immune diseases and therefore it is appropriate to use the maximum precautionary limit of 10 ng as for the immortalized lines.

It follows that the other goal of this work is the drafting or reviewing of the guidelines on impurity limits and the improvement of vaccines quality, to better protect the ones who make the aware and informed choice to get vaccinated.

Finally, we hope these results will inspire others to further investigate on new vaccines and to carry out new studies on quality and safety of vaccine components.

Ferdinando Donolato, Corvelva President

* Corvelva President
**Laureata in Chimica e tecnologie farmaceutiche, dottore di ricerca in scienze farmaceutiche. Lavora come consulente Dlg. 210, sicurezza dei farmaci, malattie professionali, inquinamento ambientale e terapie nutrizionali.

References
- Qin J, Li R, Raes J, et al.: A human gut microbial gene catalogue established by metagenomic sequencing.Nature. Nature Publishing Group; 2010; 464(7285): 59–65
- Posada-Cespedes S, Seifert D, Beerenwinkel N. Recent advances in inferring viral diversity from high-throughput sequencing data. Virus Res. 2017 Jul 15;239:17-32. doi: 10.1016/j.virusres.2016.09.016. Epub 2016 Sep 28. Review. PubMed PMID: 27693290.
- Cattonaro F, Spadotto A, Radovic S and Marroni F. Do you cov me? Effect of coverage reduction on species identification and genome reconstruction in complex biological matrices by metagenome shotgun high-throughput sequencing [version 1; referees: awaiting peer review]. F1000Research 2018, 7:1767 (https://doi.org/10.12688/f1000research.16804.1)
- Morfopoulou S, Mee ET, Connaughton SM, Brown JR, Gilmour K, Chong WK, Duprex WP, Ferguson D, Hubank M, Hutchinson C, Kaliakatsos M, McQuaid S, Paine S, Plagnol V, Ruis C, Virasami A, Zhan H, Jacques TS, Schepelmann S, Qasim W, Breuer J. Deep sequencing reveals persistence of cell-associated mumps vaccine virus in chronic encephalitis. Acta Neuropathol. 2017 Jan;133(1):139-147. doi: 10.1007/s00401-016-1629-y. Epub 2016 Oct 21. PubMed PMID: 27770235; PubMed Central PMCID: PMC5209397.
- Deisher TA, Doan NV, Koyama K, Bwabye S. Epidemiologic and Molecular Relationship Between Vaccine Manufacture and Autism Spectrum Disorder Prevalence. Issues Law Med. 2015 Spring;30(1):47-70. PubMed PMID: 26103708.
- Jarzyna P, Doan NV, Deisher TA. Insertional mutagenesis and autoimmunity induced disease caused by human fetal and retroviral residual toxins in vaccines. Issues Law Med. 2016 Fall;31(2):221-234. PubMed PMID: 29108182.

Attachments
- Epidemiologic and Molecular Relationship Between Vaccine Manufacture and Autism Spectrum Disorder Prevalence
- Metagenomics analysis report on vaccine samples

 Translated by team CLiVa - www.clivatoscana.com