MPVR vaccine study in Puglia: adverse events for 4 out of 100 children
During the hearings in the Senate to discuss the new Vaccini law decree (Ddl 770) a bomb news came out. For the first time, a pharmacovigilance study was conducted in Puglia active on one vaccine, the anti MPVR (measles, mumps, chicken pox, rubella).
So far, serious adverse events after a vaccination have been calculated taking into account spontaneous reports (called passive), doctors, parents and operators. With pharmacovigilance activeon the other hand, a group of vaccinated children is observed over time by calling the parents and periodically recording the health of the children.
In Puglia 1.672 children were recruited, all followed for a year. The results are evident here. The table on page 26 shows that reports of serious adverse events related to vaccination had an incidence of 40,69 per thousand (means 4 per cent!). It is explained, then, that about three quarters of these reports are due to vaccination.
The result was compared to the incidence observed with passive pharmacovigilance (same vaccine and same period of time) equal to 0,12 per thousand (one case per 12.000). Of these reports, around a third are due to vaccination. The difference is enormous: the serious cases collected with the study exceed 339 times the reports received spontaneously.
surprising that the authors of the study did not reveal these conclusions. The investigation ended in May (it is therefore assumed that the ASL are now informed and consequently also the parents to whom that quadrivalent is proposed and who will sign the informed consent).
The data leaked from the intervention presented in the Healthcare Commission by Antonio Affinita, general director of the Italian parents movement (Moige) who, in the past, spent himself on vaccination gratuity and for promoting the Como Confederation of world organizations against meningitis.
Here is what has been exposed in parliament.
How did you hear about the Apulian studio?
“Some parents who have always vaccinated their children have reported it to me. I have a constant dialogue with many Italian families, this was the meaning of my speech in parliament: to give voice to their perplexities ".
Was there any reaction when you exposed the Apulian data? Four out of 100 serious adverse events - for one vaccine - are important reactions ...
“Hearings are a moment of mutual listening. I was listened with keen interest. "
You spoke out against the vaccination requirement.
"Parents do not understand why a medical act such as vaccination was heavily conditioned," if you do not vaccinate your child, no nursery school "or" you will not be able to enroll the child in the summer or sports center ", to the point of absurdity" but if you pay a substantial fine, minors aged 6 and over can stay in class ”. A medical act cannot be blackmailed because - informed consent teaches us - any therapy, drug or vaccination must be understood and chosen. In this case, the right to education and sociality guaranteed by our Constitution was touched upon ”.
No blackmail, and how do you judge the premiums for those who get vaccinated? Among the proposals on the new bill we have heard of "adding credits to university students" or "points to the driver's license".
"The rewards are conditions like blackmail, as well as being non-educational (the message is that you can not study or go by car with red, if you get vaccinated, everything is fine!) They fight with free participation in health care".
Do you think that the rigidity contained in law 119 has made the number of families hesitant to vaccinate grow?
"I'm sure. I speak not of ideologically hostile families to vaccinations but of people who, not understanding the meaning of these strong ways (absence of epidemics), now doubt the goodness of vaccinations. The doubt, which was not there before, came after these impositions. Then there was the regrettable aspect of the "hunt for the greasy child", discriminating and unsustainable which risks nullifying all inclusion efforts towards children with communicable diseases, such as AIDS and hepatitis ".
He recalled that we have 11 laws governing informed consent. This is the only reason why the word "obligation" cannot be applied to health.
“Anyone who signs an informed consent accepts all the benefits, but also the risks of a therapy. Without this adhesion, no health treatment can be carried out. It is not clear why only in this case should the laws of the state be ignored. Moreover, the role of parents in their children's health choices as well as in educational ones is fundamental ".
Then there is the aspect of the risk of health treatment and the adverse events of vaccinations.
“Precisely for this reason no one can be forced. As for adverse events, I drew attention to the need to start an active pharmacovigilance, like the one that was done in Puglia. How safe are multiple vaccinations? How do we know without sample and constant pharmacovigilance studies over time? It is irresponsible to force large sections of the population to 10/12 vaccinations without worrying about observing their effects. I also mentioned the Signum study on the military which calls for the precautionary principle: no more than 5 vaccines at a time ... "
Do you think the adverse events from vaccination are underestimated?
“The study of Puglia goes in this direction. It tells us how important it is to start active pharmacovigilance. So far we have based ourselves on the Aifa report, the effect of passive reports which, however, cannot be ignored. (Click here). Attention, however, 70% of the reports come from a single region (Veneto): it is evident that we cannot consider this data collection system reliable ”.
What are the proposed changes to the bill that Moige has presented?
1. “Eliminate the compulsory nature; insert the recommendation for a number of vaccines to be established every three years by the Superior Health Council, in the light of considerations of both epidemiological and vaccine risks as well as health policy.
2. Create a pharmacovigilance system active on all vaccinations conducted by experts who have no conflict of interest.
3. Commitment by the Ministry of Health to hold a national vaccination conference every three years open to doctors to analyze prophylaxis and evaluate critical issues. The comparison should also involve parents, on the model of the Veneto Region.
4. Opening of pharmacies to vaccine prophylaxis to facilitate families.
What do you think about the fact that doctors only get 15% of the flu vaccine as Minister Grillo said?
"For a parent, knowing that about 8 out of 10 doctors don't get vaccinated reinforces perplexity and concern."