NOTE: The following is excerpted from the Corvelva website. Grazie mille a la nostra amici a Corvelva. Visit their site at Corvelva.it
We want to take stock of the situation together with you. Eight months have passed since July 2018 and in these lenght of time we have achieved extremely satisfying results. We have presented a research program and regarding the vaccines analysis we are able to make a point of reference, with the objectives achieved, those being finalised and those only planned for now.
To begin with, the analyses of 2 compounds for each vaccine have been verifyed by means of standards, using certified control standards with a concentration in the order of micrograms / mL. The compounds we have chosen are among those known for their critical hazard profile. We are talking about a cumulative quantity, a total amount of those recognized as identities and those to be identified, which can be estimated within the order of 50 micrograms / mL, in contrast to the EMA / FDA guidelines.
These tests have given positive results, therefore they fully confirm the analysis method! The contaminations observed are probably due to different and variable manufacturing process’ phenomena and topics. What has been observed in the course of the studies is an “inter-batches” variation of the composition, which makes us assume that there are some steps along the whole product manufacturing process that are difficult to control.
Summary table showing the results of analyses (Priorix tetra)
- Antigens - 3 out of 4 attenuated viruses were identified and sequenced. Rubella was detected in a very low number of copies. Varicella, mumps and measles viruses have higher mutations, probably derived from the attenuation of a large number of minor variants (quasipecies).
- Chemical Contaminants (signals) - 115-173 (29-43% known)
- Chemical toxins - NO
- Protein Contaminants - Sarcoplasmin calcium-binding protein, Actina e Vimentina
- Free peptide contaminants - NO
- Residual DNA/RNA deriving from cultured cells - Total amount of DNA: 1.7-3.7 μg/dose, the 80% of which was human (Human fetal DNA / RNA from the MRC-5 cell line). Other amount of DNA: chicken
- Adventitious viruses - Human endogenous retrovirus K, Equine infectious anemia virus, Avian leukosis virus, HERV-H/env62
- Other microbial contaminants - Proteobacteria, nematode-helminth
- Processing residues of genetic material - NO
In-depth information on the vaccines analysed
Priorix Tetra (GlaxoSmithKline) 1 Chemical composition profile study 2
READ THE FULL REPORT WITH CITATIONS HERE.