Metagenomic analysis on Gardasil 9

Metagenomic analysis on Gardasil 9

With these analyzes we came to the conclusion of the first level screening of the Gardasil9 vaccine.


Results

There is adventitious genetic material present in residual quantities. The following essential points can be summarized:

Adventitious genetic material present as DNA:

  • Battery: the percentage is relevant: 54% of the total DNA, this contamination can mainly come from the culture of yeast, but also from contaminants present in the laboratory; more whites have been made to minimize the error due to environmental contamination, but we will have a more accurate data when we make the replicates with other laboratories. Bacterial DNA could interact with adjuvant aluminum and cause allergies, inflammation and autoimmunity. Data to be confirmed.

  • Human and mouse DNA: their origin is unknown! It may be that human DNA comes from the residues present in the raw materials of the HPV virus taken from human tissues. The mouse DNA could instead be a cross-contamination from other cell lines used for the production of vaccines (it is a hypothesis). These DNAs could interact with the adjuvant aluminum and cause inflammatory and autoimmune reactions.

  • Adventitious viruses: L1 fragment of the HPV virus of double-chain DNA - comes from the process of manufacturing antigens; it is a contaminant because it poses safety problems as it is not degraded and remains in the macrophages for a long time tied to the adjuvant aluminum; its biological effect is not fully known but it can probably integrate into the host's DNA, stimulate inflammation through the production of proinflammatory cytokines and autoimmune reactions (see research by Prof. Lee).

  • Phages: they come from the production process, they are adventitious contaminants of unknown hazard. Can antibodies produced against phages interact with the bacteria of the intestinal bacterial flora? Can they integrate into the bacterial DNA of the bacterial flora?

  • Molluscum contagiosum virus: belongs to the Poxviridae family, subfamily Chordopoxvirinae, genus Molluscipoxvirus. The term pox contained in the name of these viruses derives from the vesicles (in English: poxes) produced by the smallpox virus.

  • Retrovirus: potentially integrated into DNA; they can cause neoplastic transformation and host genome mutations; they come from human and mouse DNA contaminations, such as possible cross contaminations with other cell lines.

  • Mouse leukemia virus.

  • Human endogenous retrovirus K.

Adventitious genetic material present as RNA:

  • Bacteria: the transcripts indicate that DNA is functioning.

  • Synthetic constructs (artificial sequences): they can come from the production process of antigens by genetic recombination with the plasmid; are potentially able to recombine with human DNA; the bond with adjuvant aluminum can prolong and enhance its biological effect (inflammation and autoimmunity).

  • Yeast and its viruses (L-BC virus and narnavirus): yeast RNA can give rise to allergenic proteins (which can bind to adjuvant aluminum), while viruses are not known for their effects on human cells and the microbiota.

  • Infectious equine anemia virus and mouse leukemia virus: (the latter is present both as DNA and RNA and therefore is a functioning virus): these viruses come from contamination of raw materials and must not be present.

Bibliography

  • J Inorg Biochem. 2012 Dec; 117: 85-92. Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil. Lee SH1.
  • Advances in Bioscience and Biotechnology, 2012, 3, 1214-1224 - Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil® vaccination — A case report. Sin Hang Lee

Download: CORVELVA-Report-analysis-metagenomic-of-Gardasil9.pdf