Rome, 8 April 2021 – Giorgio Palù, president of Aifa (Italian drug agency), reassures about the numbers of the anti-Covid vaccines in Italy. “In the second quarter they are coming 17 million Pfizer doses, 7-10 million J&J at the end of April. So we have doses available to arrive at the expected coverage of 500 thousand vaccinated a day“he told SkyTg24.
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Yesterday theMom, regarding AstraZeneca, spoke of thrombosis as “rare side effects”. And right in these hours the Aifa scientific technical commission noted that “no similar signs of risk have been identified at this time” by thrombotic events “for i mRNA vaccines. However, it is not yet possible to express a judgment on other vaccines that use viral vaccination platforms. “In the opinion of the CTS, attached to the circular of the Ministry of Health on the updating of the recommendations for AstraZeneca, it is also emphasized that the benefit / risk balance of the vaccine is confirmed “overall positive”. And that “in the light of the data currently available it is not possible to make recommendations regarding the identification of specific risk factors, and at the same time preventive treatments are not identifiable of thrombotic episodes “.
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Returning to AstraZeneca, Palù notes that “these rare events could not be highlighted in the validative studies, those of phase 3. It is mass vaccination that can highlight them. This does not happen only for vaccines but for all drugs. All of them. the vaccines will be followed up and studied as AstraZeneca “. He adds: “The EMA called the drug agency and AstraZeneca. A review of the 79 thrombosis cases was made and none occurred in the second vaccination. I remember that about 20 million British were vaccinated with AstraZeneca. For the second dose there is currently no contraindication“. Then he explains:” The confidence of the Italians was taken into consideration, it was a debated, painful, but unanimous decision on the part of all the scientific advisers that Minister Speranza had gathered around him “.
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The data. “The safety committee of the European drug agency Ema – the virologist told Corriere della Sera -” has reported that there is a direct relationship between this vaccine and an adverse effect. cerebral deep vein thrombosis that goes with the decrease in blood platelets. They are very rare forms, one in a million in the normal population. They have now been observed more frequently, about 1-2 every 100 thousand vaccinated. 86 cases were analyzed, 19 of which fatal, compared to 20 million vaccinated “. Palù specifies that” there was no lack of foresight on the part of the regulatory authorities “, he assures. Indeed,” the American FDA and European EMA agencies have authorization for large-scale use was issued on the premise that one was exercised careful monitoring of the relationship between risks and benefits“. President Aifa clarifies the concept as follows:” Above 60, if you take Covid, you have a 3 in 100 chance of dying from it, a risk that increases with age. Vaccinated with AstraZeneca would, based on the reported data, have a one in 100,000 chance of developing a rare thrombosis with a severe prognosis. In practice, the benefit of the protection given by prophylaxis is infinitely greater than the danger “.
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