Giorgio Palù, president of Aifa and member of the technical scientific committee (CTS) as a virologist analyzes the reasons that led the international drug organizations to change the path of the AstraZeneca vaccine. On what basis did the EMA update the information?
“The agency’s safety committee reported that there is a direct relationship between this vaccine and an adverse effect. It is a cerebral deep vein thrombosis that is accompanied by a decrease in blood platelets. They are very rare forms, one in a million in the normal population. Now they have been observed more frequently, about 1-2 per 100,000 vaccinated. 86 cases were analyzed, 19 of which were fatal, compared to 20 million vaccinated “
Why does this association only emerge now?
“Such a rare event could not be detected in the clinical trial but only when mass vaccination was initiated, in large numbers. There was no lack of foresight on the part of the regulatory authorities. The American FDA and European EMA agencies have issued authorization for large-scale use on the premise that careful monitoring of the relationship between risks and benefits is exercised “
Explain this technical concept that is hard to understand by those who are very afraid to get vaccinated.
“Over the age of 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 based on reported data would 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 ».
“We still don’t know if the cases of cerebral venous thrombosis are linked to genetics. The hypothesis remains that it is an autoimmune reaction. But we are in the field of hypotheses ».
Is the pill in the dock?
Can anyone who has already taken the first dose have a booster with a different preparation?
“We will have time to evaluate it. The vaccination has just started and we can wait three months for the booster. In the meantime the studies on these events will have been deepened “
After so many counter-orders, how can we convince people of all ages, young and old, not to lose faith in AstraZeneca since, among other things, at first Italy had given the indication to restrict the administration of the vaccine to the under 55?
«Never as in this case has science raced to provide us with an essential protection for health without violating any biological, ethical and medical rules. And further proof of having confidence in science, bodies and agencies that carry out surveillance on the safety of medicines. Let us recall how many banal drugs, including aspirin itself, have first undergone a reduction and then a limitation of use. A transparent, live communication from EMA to civil society must make it clear that there is no need to fear. Medicine is aimed at biological entities, the human species, where every single individual is different. Therefore, the existence of an individual predisposition cannot be excluded ”.
Why has cerebral venous thrombosis not been reported in association with RNA vaccines which also target the same viral protein as AstraZeneca?
“There have been some rare reports, but not of this type.”
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