Vaccine reports missing: Aifa trial, Ministry of Health, Iss and Cts

The Italian institutions do not appear to be in possession of the necessary documents to verify the efficacy and safety of the anti-covid vaccines, which would make it possible to maintain the conditional authorization system: this is basically what emerged from a grueling study and research work. out of some lawyers from the IDU (Human Rights Instance) and from the DUS (Human Rights and Health) association against Aifa (Italian Medicines Agency), Ema (European Medicines Agency) and the Ministry of Health. A true search for the truth, which, based on the results that emerged, last March 4th got the IDU association to file a lawsuit against Aifa, the Ministry of Health, the CTS (Scientific Technical Committee) and the ISS (Higher Institute of Health) to the Rome Public Prosecutor’s Officeaccused of having committed the crimes omission of official acts, abuse of official acts, manslaughter, personal injury, ideological lie, provided alarm, false public document.

To better understand the story, however, we need to make a brief introduction. The Anti Covid-19 vaccines have not received an unconditional marketing authorization from EMA or AIFA, but conditional authorization, a procedure subject to specific requirements that pharmaceutical companies should guarantee and submitted for inspection by the authorities. These are the same leaflets for the anticovid-19 vaccines to specify it, but not only. What is probably even more important is the fact that Aifa itself puts the pen to paper this concept, which by decision n.318 of 23 December 2020 has essentially asked companies to submit the following documents: the first “Psur” (Periodic security update report) within 6 months of the approval and the interim security reports to be submitted from January 2021 to December 2023, the month in which the final report is to be made available.

It is therefore precisely with the desire to verify compliance with these requirements that the associations’ lawyers decide on 29 November 2021 to formulate the request for access to AIFA, which requests the provision of “Interim Reports” and “Psur”. The latter, however, confirms on 28 December 2021 and in the person of CEO Nicola Magrini that he is not in possession of the necessary documentation as such data would be of a “confidential nature”, being the “exclusive property of the manufacturing companies”. However, applicants are encouraged to contact the EMA to find preliminary reports, while to consult the PSURs, a link to the site is provided for the same, which, however, leads to a page that no longer exists. On December 29, an application for access to the file will be sent to the Ministry requesting the delivery of Psur and the interim safety reports. Even the latter confirms, however, in the personality of General Manager Dr. Giovanni Rezza, February 2, 2022, that he is not in possession of the documentation in question. Nevertheless, EU Regulation 507/2006 in Art. 9 provides that the periodic safety update reports are to be submitted to the Agency and to the Member States immediately upon request or at least every six months after the issue or renewal of a conditional marketing authorization, so that the Italian State as a Member State would apparently have every right to request surrender.

Anyway the investigation continues and on December 29, 2021, the request will be sent to the EMAwho at first claims not to understand what the required relationships are, then essentially sees previews and finally on February 9, 2022, he opposed his refusal access to documents for a number of reasons, including reasons for which the Agency would not have identified any overriding public interest which justifies the publication of the requested documents and which precedes the protection of private interests: the proliferation of documents would in fact seriously undermine decision making.

It is therefore for all these reasons that the complaint was lodged. But to get a clearer idea of ​​the mindset of those who made this search for the truth, we asked for a comment from the lawyer Enzo Iapichino, one of the lawyers who investigated the case. “What does all this mean? It means we have extortion legislation in Italy”said the lawyer, stressing that “if on the one hand certain categories of subjects who choose not to be vaccinated can not be paid, on the other hand if you decide to ask for the documents that support the effectiveness and safety of the vaccines , they are not provided and we do not even know if they exist ».

[di Raffaele De Luca]

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