Here we are! We are happy to inform you that Corvelva has pre-published the methodology of recent metagenomic analyzes.
As you know, Corvelva has been focusing on the for almost a year analysis of various vaccine samples, and the first recently published data concern the presence of genetic material in some currently marketed vaccines, analyzed by NGS (Next Generation Sequencing, also known as deep sequencing), an innovative sequencing method from which it is possible to reconstruct the entire sequence of genomes viral DNA and RNA and bacterial genomes present in the sample and compare it with the reference genomes present in public databases.
Having said that, we had set various targets for our project, certainly to verify the compliance of the vaccines analyzed as a first aim, but also, as we like, to make our analyzes available to everyone not only in the results, but also in the method and replicability .
Thanks to this publication, the method for sequencing the genetic material that may be present in vaccines as an impurity is made public, which will allow anyone to contact any laboratory equipped for "deep sequencing" and be able to replicate the analysis. We assure you that compared to 5 years ago, the technology for "deep sequencing" is easy to find.
This allows everyone, in every part of the world, to become a controlling body without having to invest large amounts of money to refine the extraction method. Corvelva waited months before being able to give the first results and funded the laboratories to work on this.
For us it is truly an important achievement, regardless of the content of the publication, extremely technical and focused only on the method therefore not popular or useful strictly to the cause, this step moves our battle to a higher level: from Melbourne in Rome, anyone can independently verify the genetic material contained in any vaccine.
In the recent pre-published article 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 was used to analyze different types of biological matrices, including the two batches of a measles-mumps-rubella-chicken pox vaccine we analyzed (the Priorix Tetra), with the aim of demonstrating the ability of this system to characterize the biological component in a complex matrix.
There are other scientific publications attesting that, through NGS, it has been possible to demonstrate the causal link of the damage with the vaccine sample: now in the presence of damage it can be verified independently and it can be demonstrated in the appropriate locations.
Yes, this point is vital for us, now in Italy Law 210/1992 is a chimera, an obstacle course made of obstructionism, denial and bureaucracy. Now there will be an additional instrument of struggle and, in perspective, it will be possible to change the paradigm of compensation for damage, going to demonstrate that the cause, and the consequent compensation, lies with the same manufacturer of the vaccine drug. There will be a lot of work on this, but this pre-publication is only the first step, we don't stop.
Returning to the pre-published article on F1000research, it can be observed that about 80% of the sequences obtained with NGS technology on the two vaccine samples, consists of human DNA, as an impurity present in the manufacturing process; on our site we have already made public the analysis certificates of the seven samples studied and it appears that the amount of total foreign DNA in Priorix Tetra is not residual and is approximately 2 micrograms, coming from the human fetal cell line MRC-5 used to grow rubella and chickenpox viruses.
This result confirms the research of the “Epidemiologic and Molecular Relationship Between Vaccine Manufacture and Autism Spectrum Disorder Prevalence". It should be remembered that Dr. Deisher has preliminarily demonstrated that fetal DNA presents safety problems, as it can lead to recombination with the host's genomic DNA, a mechanism responsible for carcinogenesis and autoimmune diseases and therefore it is It is appropriate to use the maximum precautionary limit of 10 ng as for the immortalized lines.
It follows that the other purpose of this work is the drafting or revision of the guidelines on the limits of impurities and the improvement of the quality of vaccines, for greater protection for those who choose, in an informed and informed way, to get vaccinated.
Finally, we hope that these results will stimulate others to investigate new vaccines and to start new studies on the safety of vaccine components.
Ferdinando Donolato * and Loretta Bolgan **
* President Corvelva
** Graduated in Chemistry and Pharmaceutical Technologies, PhD in Pharmaceutical Sciences. He works as a Dlg consultant. 210, drug safety, occupational diseases, environmental pollution and nutritional therapies.
- Qin J, Li R, Raes J, et al .: A human gut microbial gene catalog 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.
- Epidemiologic and Molecular Relationship Between Vaccine Manufacture and Autism Spectrum Disorder Prevalence translated into Italian by CLiVa Toscana