The introduction of the vaccination obligation “is a political and autonomous decision of each Member State and completely independent of the agencies”. Guido Rasi, former director of Ema, now adviser to Commissioner Figliuolo, explains this in an interview with Corriere della Sera, adding that “the European one has already issued a definitive decision. He used the conditional approval tool that imposes further measures on the manufacturer, but it has nothing to do with the legal validity or completeness of the trial. The indications for the four vaccines currently in use in Europe are therefore definitive. They have completed all three canonical experimental steps required by Ema. As with all other 1,000+ products approved in 25 years. The only conditions imposed by Ema concern guarantees regarding the quality of the product. Today 5 billion people have been vaccinated, talking about the experimental phase is ridiculous ”. The vaccination coverage that would secure Italy from the resumption of the epidemic, according to Rasi, would be “probably a very homogeneous 80%. Unfortunately, the Delta variant lost at least 14% of effectiveness on the ability to prevent infection. These numbers are therefore subject to continuous verification, as we have learned with this virus. Territorial homogeneity is fundamental. Inhomogeneities greatly reduce the efficiency of a mass vaccination. Where the percentages drop, outbreaks of infection are created, hospitals are overloaded, the virus is put back into circulation and the onset of variants is favored in outbreaks. The Delta has spread just like that, in India, in regions with a lower rate of immunization. Let’s not forget the outbreaks of measles outbreaks in areas where children were not vaccinated and the rabies over avoidable deaths. Obligation has quickly restored safety and measles cases have drastically dropped ”. The commissioner structure “aims at 80% set by the Technical Scientific Committee – continues Rasi – remodeled with respect to the 70% initially planned, precisely to compensate for territorial unevenness and the effects of the Delta variant. The impact of Delta in children remains to be verified. The vaccination machine has now been run in and allows great flexibility. The doses are now available. We will have to closely monitor the population from 0 to 12 years old in light of the Delta variant which in the US is causing an increasing number of hospitalizations even in this age group. The opening of the schools will be a verification. The next 3 or 4 weeks will be diriment. On the third dose for everyone and whether Ema’s green light is needed? It is not strictly binding, but it is recommended. The decline over time of immunity, both vaccine-induced and natural, is now documented even if unfortunately there is no test that with absolute certainty discriminates a protected individual from an unprotected one. We also expect substantial differences by age group. Fda will hold a first meeting on the third dose and the general population on September 17 (on the fragile it has already given the green light) and Ema will communicate by the end of the month if it believes it has enough elements to pronounce. Obviously, for high-risk populations such as the immunosuppressed, it is reasonable to decide quickly at the national level, exactly how our Aifa agency is oriented ”.
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