Grazie mille a la nostra amici a Corvelva.
Click here to see this full report at the Corvelva site.
We want to take stock of the situation together with you. Eight months have passed since July 2018 and in these length 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 verified 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.
Such analyses have allowed us to achieve the following steps:
- Conformity assessment of composition as outlined in the vaccine datasheet
- Screening for chemical and protein/peptide contaminations, as well as those deriving from genetic material
- Confirmatory study of chemical and protein target compounds through con standard certificates of inspection
The following vaccines have been submitted to an initial screening:
- Infanrix Hexa - GlaxoSmithKline Biologicals s.a.
- Priorix Tetra - GlaxoSmithKline S.p.A.
- Hexyon - Sanofi Pasteur Europe
- Gardasil 9 - MSD Vaccins
These other vaccines were analyzed as initial screening:
- Measles vaccine live B.P. - Poonawalla Group (Profarma AG, Baar)
- MMR vax Pro - MSD Vaccins, Francia
- PolioInfanrix - GlaxoSmithKline, Belgio
- Fluad - Seqirus Srl, Siena
- Vivotif - PaxVax, Regno Unito
The study is structured in:
Impurity and chemical and protein contamination analysis
- The LC-SACI / ESI-MS analysis system associated with the pioneering SANIST platform has been used to perform an initial identification screening on the vaccines of interest, as well as to confirm it with the control standards, with a minimum level between the nanograms and micrograms / dose
- MALDI-TOF-MS technology has been used to study the insoluble macromolecules found in the vaccines
Analysis of genetic material
- Test for the presence of nucleic acids (DNA / RNA) of human and animal origin and of microorganisms (viruses, bacteria) using the Next Generation Sequencing method, which made it possible to quantify the genetic material sequence contained in the vaccines in a highly specific and accurate way
- Verification of correspondence of bacterias and live attenuated and inactivated vaccine viruses genomic sequences (presence of genetic variants)
Quantitative analysis of metals
- The ICP-MS technology made it possible to quantify the metals present in the vaccines with a minimum limit of 5ng / dose.
Analysis of chemical and protein contamination
After a first screening that had identified the presence of hundreds of chemical signals inside the vaccines, confirmation tests were carried out by means of standards of 2 compounds per vaccine, using certified control standards, chosen from those known for their critical hazard profile and for the non-residual quantity (such as to be considered components of the vaccines, therefore to be included in the technical data sheet and quantified).
These tests have given positive results, therefore they fully confirm the analysis method. So far only two compounds have been tested for economic reasons solely, in fact this study is not complete as it is limited by the considerable cost of the survey but we have chosen to identify the more relevant standards as for the regulatory restrictions and it is to be considered that this kind of in-depth investigation should not after all be up to us.