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AIFA makes available the Post-marketing surveillance report of vaccines 2014-2015

The Italian Medicines Agency makes available the Post-Marketing Surveillance Report on vaccines for the years 2014 and 2015. The main objective of the publication, now in its fifth edition, is to provide correct and transparent information on vaccines, a precious resource for public health, the efficacy of which is attested by scientific evidence. Over time, vaccinations have unequivocally contributed to the significant reduction in morbidity and mortality, especially in childhood, and to the reduction in the spread (up to the eradication, as in the case of smallpox) of potentially lethal or disabling communicable infectious diseases, with a consequent marked reduction in human, economic and social costs.

The Report provides a snapshot of the status of reports relating to the safety of different types of vaccines in the period under review.

The first part shows the processing carried out on the spontaneous reports of suspected adverse events following immunization recorded in the National Network of Pharmacovigilance. It is good to remember that it is, precisely, a "suspect" of adverse reaction, based exclusively on the temporal coincidence between the events and there is no certainty of a causal relationship between the administered product (vaccine) and the reaction. The analysis aimed at ascertaining the existence of a possible cause-effect relationship is a continuous daily activity carried out by the AIFA Post-Marketing Surveillance Area in collaboration with the Regional Centers of Pharmacovigilance and the Istituto Superiore di Sanità (ISS).

The second part describes the main regulatory events concerning vaccines, i.e. the insights and actions undertaken at regional, national and European level in the two-year period under review in the context of post-marketing surveillance.

The Report concludes with insights dedicated to vaccine-preventable diseases in relation to coverage trends, with a description of thepharmacovigilance activities coordinated by AIFA and other initiatives on the subject.

Starting from Monday 5 June it will be possible to download the typographic version of the Report from the AIFA portal.

AIFA press release – 01 June 2017

AIFA. Report on postmarketing surveillance of vaccines in Italy 2014-2015

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Vaccines, thousands in the streets, worrying AIFA data published, but where are the journalists?

THEYesterday 3 June 2017 thousands and thousands of people took to the streets in many Italian cities, to protest against the 'slightly' authoritarian decree wanted by the minister Beatrice Lorenzin, which provides for the obligation for twelve vaccinations, under penalty of exclusion from schools of all levels. No media outlet, or television, reported the event. A few days ago, after Codacons had filed a complaint against AIFA, data on reports of adverse reactions caused by vaccines in the last three years were published, which show that there are over twenty-one thousand, with hundreds of serious cases, and five deaths. No press or television reported the news.

It is also clear from these things why Italy is in seventy-seventh place in the world ranking of press freedom, because perhaps it doesn't exist. The media have lined up solidly in recent months in support of the official theses on vaccines, on the fact that they are absolutely safe, that it is right to make them mandatory, without even mentioning what the current law would provide for vaccine safety. Often real media ambushes have been organized in various television studios in which, with multi-tested media techniques, the unfortunate exponent of those who would like more safety in the field of vaccines, has been passed off as a poor moron.

The majority of those who are defined as no-vax are not actually against vaccines, but are primarily for the freedom of therapeutic choice, a sacrosanct thing enshrined in our Constitution. Then I am for the right to study, another sacrosanct thing always enshrined in our Constitution. Finally, those who took to the streets yesterday simply want safe vaccines, administered intelligently, when truly necessary, and not indiscriminately, as provided for by the Decree Law which should be published shortly. And intelligent administration could spare most of the adverse reactions also reported by AIFA.

The fact then that very good doctors are banned only because they suggest caution in the administration of vaccines, with reasons that, among other things, have yet to be made public after some time, while proven criminals remain quietly in their place, is something that makes us reflect on the trend of our country, in which it seems that those with criminal attitudes, in every sector of public life, are better protected than those who behave honestly and truthfully. Personally, I am very tired of the reality we are experiencing in Italy, thanks to a political class which, in addition to serving only its own interests, also seems to be fierce against its people, damaging them in every way.

And as president of the association Let's Take Back the Planet – Human Resistance Movement I am extremely outraged by what is happening in our country, from many points of view, but in particular by what they want to force us to do with regard to vaccines, which in fact gives a huge gift to those 'benefactors of humanity' who are the pharmaceutical companies, or drug multinationals, if you prefer. So I declare that from now on we will fight against the modalities imposed on us by the government, and we will not stop until we have completely affirmed reasonableness, true science and humanity in the vaccination field, and beyond.

In fact, in this regard, aware of the not so many veiled government intentions to strike in the therapeutic field everything that escapes the clutches of multinationals, starting from homeopathy, to continue with everything that proposes natural therapeutic approaches, we want to propose the establishment of a Association for Free Therapeutic Choice, which brings together doctors, holistic operators and all citizens who recognize themselves in this desire for free choice. The intent is primarily to offer assistance, including legal assistance, to doctors who are ending up in the crosshairs of the Order of Doctors, which if it were abolished with all the other orders we would get rid of useless trappings.

PWe would like to provide concrete assistance, including legal assistance, to all parents who find themselves Now in the need to be protected in the face of undemocratic government impositions, because they have to enroll their children in school, and maybe they don't want to vaccinate them. Finally, we want to go on the counterattack, against a government that seems to have no intention of respecting some elementary rules of democracy enshrined in our republican Constitution, fully affirming the freedom of therapeutic choice in every medical sector, even if this were to take away, God forbid, profits from drug multinationals.

Last but not least, we are working on the creation of an online archive to make available to people all the useful and necessary material to move around in the sector we are talking about, as well as a sort of 'telematic counter' of the series the expert replies, to be of help to all those who, both in the field of vaccines, but also of therapeutic choice, want to continue to freely exercise their rights.

In the meantime, let's start by participating today in Bergamo in this important initiative, called The Voice of Ghosts which will see participants damaged by vaccines, depleted uranium, asbestos, chemical substances and biological agents, precisely to give voice to a category that does not seem to exist in Italy, a category of ghosts precisely, which is that of the damaged. Come on, it's time to raise your head, united we can win.

from Massimo Rodolfi

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco