With these analysis we have reached the conclusion of the first level screening of the Hexyon vaccine
Focal points of the results
- DNA from bacterial cultures used for the production of toxins (diphtheria, tetanus and pertussis) and Haemophilus influenzae B antigens: this DNA is immunogenic and is able to stimulate the formation of inflammatory cytokines and thus contribute to a consistent at the injection site and systemic inflammation. The question arises whether these fragments are potentially able to cause autoimmune reactions and integrate into human DNA causing mutations. Since aluminum adjuvant is also present in the vaccine, these fragments are probably bound to aluminum, which protects their degradation and enhancing their biological and toxicological effects, still largely unknown.
- Monkey Cercopithecidae DNA: this DNA can be derived from Vero cells, i.e. immortalized. This DNA is found in traces and is degraded, so it should not be able to integrate into the host DNA. The fact remains that its presence is a proof of the incomplete reaction of formaldehyde and glutaraldehyde on the genetic material, which should instead be completely destroyed, and the presence of aluminum, as for the other genetic material, can make it stable to degradation over time, expanding potential toxic effects.
Adventitious viruses analysis:
- Phages: tetanus phage (Clostridium phage phiCT453A). It can potentially cause autoimmune diseases, especially if bound to aluminum.
- Vectors used for cloning, including the SV40 vector: these are fragments of RNA that most likely come from the production process of the hepatitis B antigen. NB: in this case the SV40 is not the adventitious virus found in the attenuated polio vaccine, but a vector normally used for genetic recombination for the production of engineered vaccines. The toxicology of these fragments is not known but, if they are used to integrate fragments of genetic material, they could also integrate into the host DNA. Since the amount is very small, the biological effect is not possible to define. Also the toxicity of this contamination linked to aluminum remains impossible to define.
- RNA from bacterial cultures used for the production of toxins (diphtheria, tetanus and pertussis) and Haemophilus influenzae B antigens: what it was said for DNA it can be applied also to RNA. In reality we are dealing with bacterial DNA and RNA partially degraded by the effect of formaldehyde, and therefore it is not possible to understand from these data if they are able to integrate into DNA, while it is very likely that they are able to cause persistent inflammation and autoimmunity.
- Monkey RNA: RNA may be able to form proteins, but these have not been detected in mass spectrometry (either because they are below the limit of nanograms, or because they are linked to aluminum and therefore not sequenceable and unidentifiable, or because this RNA is not working). As for bacterial RNA it can bond to aluminum and cause autoimmunity and inflammation.
Overall, this analysis tells us that compared to Infanrix hexa (the other analysed hexavalent) the treatment with formaldehyde is much milder, and there is genetic material from the starting cultures, which should not be there. This may pose a potential risk for autoimmunity, local and systemic inflammation, genetic mutations.
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Translated by team CLiVa - www.clivatoscana.com