The previous report on metagenomic analysis of Gardasil 9 revealed the presence of L1 fragments of the HPV virus genome, but we didn't investigate what types of papilloma virus they belong to (the vaccine contains strains 6, 11, 16, 18, 31, 33, 45, 52, 58).

The analysis in proteomics by LC-MS revealed that strains 11 and 58 were missing, raising a doubt about the efficacy of the vaccine, in fact their presence could have various interpretations:

1. subthreshold presence of the antigenic protein;
2. the protein is present in the unidentified part because it is chemically bound to aluminum and therefore undigestible and insoluble (we fear that the lack of digestion in vitro also occurs in vivo and this would prevent the formation of specific antibodies against the proteic antigen in the vaccine, which needs to be fragmented into short peptides in order to stimulate the correct antibody response);
3. absence of the protein.

In each and every case the immune response could be partial or null (in the report a brief explanation of how the immune response occurs).

Remind that in order to get the humoral immune response, which leads to the formation of antibodies as occurs after vaccination, the antigen must be digested and exposed on the membrane of the antigen-presenting cells (APC).

Remind that the vaccine preparation process involves the recombinant synthesis of the main L1 proteins of the capsid that are self-assembled in a shell of 72 pentameric capsomers to form viral particles (VLP). The assembled pseudovirus is very similar to the native human papillomavirus and is highly immunogenic.

Our analysis have confirmed the following:

• From the study in metagenomics of the L1 fragments of the vaccine HPV strains it was found that the 58 strain is absent both as DNA and as RNA, this may be due to the same reasons for which the protein is not found, as also the DNA sequencing and of RNA could be hampered by the bond with aluminum (as demonstrated in his studies by Professor Lee mentioned later in the notes), or indeed the antigen might be missing.
  
  
• The absence of DNA and the presence of RNA for types 16, 6, 11, 33, 52, 45, 31 indicates that the strains are there and there is also evidence in the analysis with LC- MS with protein detection, except for strain 11.
  
  
• Ppo Strain 20 is not stated in the data sheet so it can be considered a potential contaminant.
  
  
• Virus Copies of viruses referred to as Human papillomavirus and Unsigned Papillomaviridae are pieces of L1 fragments that cannot be attributed to a specific strain.
  
  
• For further information, the L1 fragments present in the greatest number of copies were sequenced, ie strains 18, 16, and 6 and were confirmed.
  
  
• The implications related to the presence of these fragments are those already reported by prof. Lee in his studies, namely that the presence of aluminum stabilizes degradation, enhancing its ability to activate a powerful long-term inflammatory response and to be transported through the lymphatic system to macrophages in various districts of the body.

In conclusion

• Absence of the 58 strain is confirmed.
• Only the RNA is present in strain 11 and with a very low number of reads (6 reads).
• 545 reads of the strain 20 are a probable contamination that attests a non-conformity with the technical sheet.

Download: CORVELVA-Insights-sequences-L1-HPV-genome-Gardasil-9.pdf

Translated by team CLiVa - www.clivatoscana.com