During the hearings in the Senate to discuss the new law decree Vaccines (Law Decree 770) a bombshell came out . For the first time, an active pharmacovigilance study on a single vaccine, the anti-MPVR (measles, mumps, varicella, rubella) was conducted in Puglia.

Serious adverse events after vaccination have been calculated so far taking into account spontaneous (referred to as passive) reports from physicians, parents and practitioners. With active pharmacovigilance, however, a group of vaccinated children is observed over time, calling parents and periodically recording the health status of the young.

In Puglia, 1,672 children were recruited, and all been followed for one year. Here the evident results. The table on page 26 shows that serious adverse events reports related to vaccination have had an incidence of 40.69 per thousand (means 4%!). It is explained, next, that about three quarters of these reports are DUE to vaccination.

The result has been compared to the passive pharamcovigilance observed incidence (same vaccine and same period of time) equal to 0.12 per thousand (one case per 12,000). About one third of these reports is due to vaccination. The difference is huge: the serious cases reported with the present study exceed by 339 times the reports received spontaneously.

It is surprising that the authors of the study did not reveal these conclusions. The investigation ended in May (it is therefore assumed that the ASLs are now informed and consequently also the parents to whom this quadrivalent is proposed and who will sign the informed consent).

The data have leaked from the intervention reported in the Health Commission by Antonio Affinita, general director of the Italian parents movement (Moige), which in the past had promoted free vaccination and the Como Confederation of the world organizations against meningitis.

Here is what has been exposed in the parliament.

How did you learn about the Pugliese studio?

"Some parents told me they have always been vaccinating their children. I have a constant dialogue with many Italian families, this was the meaning of my speech in Parliament: give voice to their perplexities".

Were there any reactions when you exposed the data from Puglia? Four serious adverse events out of 100 - for a single vaccine - are important reactions ...

"The auditions are a chance for mutual listening. I have been listened to with lively interest ".

You have given your opinion against the mandatory vaccination.

"Parents do not understand why a medical act such as vaccination has been heavily conditioned,"if you do not vaccinate your child, no kindergarten" or "you can not enroll the child at the summer or sports center", taking it to point of absurdity "but if you pay a substantial fine, the child aged 6 and over can stay in class". A blackmail can not be made of a medical act because - informed consent tells us - any therapy, drug or vaccination must be understood and chosen. In this case the right to education and sociality guaranteed by our Constitution has been affected".

No blackmail, and how do you judge the prizes for those who get vaccinated? Among the proposals on the new bill we have heard of "add credits to the university" or "points to the driving license".

"The awards are conditions like blackmail, in addition to being non-educational (the message is that it is ok to not study or to run a red light with your car, but if you get vaccinated it is all right!) go against the free choice of medical treatment."

Do you think that the rigidity of the law 119 has increased the number of the families who are hesitating about the vaccinatation?

"I am sure about it. I am a spokesman for families who are not ideologically hostile to vaccinations but for people who, not understanding the sense of these strong ways (absence of epidemics), now have doubts about the goodness of the vaccinations. The doubt, which was not there before, came after these impositions. Furthermore there was the unfortunate aspect of "discriminating and unsustainable" hunt for the child, "which risks undermining all efforts to include children with transmissible diseases, such as AIDS and hepatitis".

You have recalled that we have 11 laws that regulate informed consent. Just this one reason would be enough to not apply the principle of "obligation" to the whole  field of health.

"The person who signs an informed consent accepts all the benefits, but also the risks of a therapy. Without this accession no health treatment can be carried out. It is not clear why only in this case the laws of the state should be ignored. Above all, the role of parents in the health choices of their children as well as in those of education is fundamental".

And there is also the aspect of the risk of any health treatment and of the adverse events following the vaccinations.

"Precisely for this reason nobody can be forced. As for the adverse events, I drew the attention to the fact that we need to start up an active pharmacovigilance, like the one that was carried out in Puglia. How safe are multiple vaccinations? How do we know it, with no active pharmacovigilance sample and constant studies over time? It is irresponsible to force large sections of the population to 10/12 vaccinations with no concerns about observing their effects. I have also mentioned the Signum study on the military that calls for the precautionary principle: no more than 5 vaccines at a time ... "

Do you think that adverse events following vaccination are underestimated?

"The study carried out in Puglia goes in this direction. It tells us how important it is to start up an active pharmacovigilance. We have relied on the AIFA reports so far, an effect of passive reports that, however, can not be ignored. (Click here). Note that, however, 70% of the reports have come from a single region (Veneto): it is clear that we cannot consider this data collection system reliable".

What are the amendments that Moige has propososed to modify the bill?

1. "To abolish the obligation; to replace it with the recommendation for a number of vaccines to be defined every three years by the Higher Health Council, in the light of considerations of both epidemiological and vaccine risks as well as health policy.

2. To Create an active pharmacovigilance system on all vaccinations conducted by experts who do not have conflicts of interests.

3. A Commitment by the Ministry of Health to hold every three years a national vaccination conference for doctors to analyze prophylaxis and assess critical issues. The debate should also involve parents, following the model of the Veneto Region.

4. Opening of pharmacies for vaccination prophylaxis to facilitate families.

What do you think of the fact that only 15% of doctors are vaccinated against influenza, as Minister Grillo said?

"As a parent knowing that about 8 out of 10 doctors do not get vaccinated reinforces perplexity and worries".