With these analyses we have finished the first level screening of the Gardasil 9 vaccine.
Presence of adventitious genetic material in residual quantities. The following essential points can be summarized:
Presence of adventitious genetic material as DNA:
- Bacteria: The percentage is significant: 54% of the total DNA, the contamination can derive mainly from yeast culture, but also from contaminants in the laboratory; more blanks have been made to minimize the error due to environmental contamination, but we will have more accurate data when we make replicates with other laboratories. The bacterial DNA could interact with the adjuvant aluminum and cause allergies, inflammation and autoimmunity. Data to be confirmed.
- Human and Mouse DNA: their origin is not known! It may be that human DNA could instead be a cross-contamination from other cell lines used for the production of vaccines (it is a hypothesis). These DNA could interact with the adjuvant aluminum and cause inflammatory and autoimmune reactions.
- Adventitious viruses: fragment L1 of the HPV virus double strain DNA – comes from the antigen manufacturing process; it is a contaminant because it poses safety problems as it is not degraded and remains in the macrophages linked to the adjuvant aluminum for a long time; its biological effect is not fully known but it can probably be integrated into the host DNA, stimulate inflammation through the production of proinflammatory cytokines and autoimmune reactions (see research by Prof. Lee).
- Phages: they derive from the manufacturing process, they are adventitious contaminants of unknown hazards. Can antibodies against phages interact with bacteria in the intestinal bacterial flora? Can they integrate into the bacterial flora?
- Molluscum contagiosum virus: it belongs to the family Poxviridae, subfamily Chordopoxvirinae, genus Molluscipoxvirus. The term pox contained in the name of these viruses comes from the vesicles (poxes) produced be the smallpox virus.
- Retrovirus: potentially integrated into DNA; they can cause neoplastic transformation and mutations of the host genome; they derive from the contamination of human and mouse DNA, such as possible cross-contamination with other cell lines.
– Mouse leukemia virus.
– Human endogenous retrovirus K.
Adventitious genetic material present as RNA:
- Bacteria: the transcripts indicate that the bacteria are present and active during the manufacturing process.
- Synthetic constructs (artificial sequences): they may derive from the antigen production process by genetic recombination with the plasmid; they are potentially able to recombine with human DNA; the link with the adjuvant aluminum can extend and enhance the 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 effects on human cells and microbiota.
- Infectious equine anemia virus and mouse leukemia virus: (the latter) is present both as DNA and RNA and therefore it’s a complete virus). These viruses derive from the contamination of raw materials and must not be present.