An announcement about the AstraZeneca vaccine and whether it is associated with a rare clot formation was issued by the European Medicines Agency on Tuesday afternoon after the statement of a top EMA officer, Marco Cavaleri in the Italian newspaper “The messenger”. EMA said in a statement that "it continues to examine whether the AstraZeneca vaccine against Covid-19 is associated with rare clot formation". It is also emphasized that the security committee of the European regulatory authority “has not yet reached a conclusion and the examination is ongoing” and it is stressed that the decision on the matter will be announced tomorrow Wednesday or Thursday.
For her part, EU Health Commissioner Stella Kyriakidou said in a post that the Commission is in close contact with the European Medicines Agency, “In close contact with the European Medicines Agency on the pharmacovigilance assessment of the AstraZeneca vaccine. The evaluation is expected late Wednesday” wrote on Twitter.
After the “freeze” vaccines with this vaccine in different countries, the EMA had announced on 18 March that the benefits of the AstraZeneca vaccine continue to outweigh the risks and that its use remains safe.
The agency had, however, explained at the time that there was a possible link to rare cases of blood clots and that it would make updated recommendations at its security committee meeting this week..
The statements that caused concern
Specifically, The head of the vaccination strategy of the European Medicines Agency argued that "in my opinion, we can say it now, it is clear that there is a connection with the vaccine ", although it was not clear what provoked such a reaction. He hinted that this connection would be confirmed by the European Regulatory Authority in the coming hours..
As broadcast by ANSA, “It is now increasingly difficult to say that there is no link between the AstraZeneca vaccine and very rare cases of abnormal blood clots associated with low platelet counts.”. This is what Cavaleri said speaking to the Italian newspaper about the investigations carried out for the cases of thrombosis that have been recorded in people under 55 years, mainly women.
The EMA official explained that the evaluation process has not yet been completed. “This week we will give some preliminary instructions, but it will be difficult to point out age limits as various countries have done. For the simple reason that we are a regulatory authority and must have very specific data on the benefit relationship- risk”.
“We try to have an accurate picture of what is happening, to define the syndrome in detail”, he even mentioned. Asked if we can say that the rare syndrome is related to the vaccine, he replied: “In my opinion we can say that now, it is clear that there is a relationship with the vaccine. However, we do not yet know what causes this reaction”.
Cavaleri insists, however, that the benefit-risk balance remains in favor of vaccination. As he mentioned, the different age groups will be examined in more detail. “Young women often star in cases of thrombosis, suffer less from the effects of the coronavirus. So we have to assess the benefits and the risks for them. Sure, do not forget that even young women end up in intensive care due to Covid. Therefore, a very careful study will be needed to determine whether the benefit-risk ratio is in favor of vaccination for all ages.”, notes.
“The instructions for this product will definitely be updated, with reference to that side effects, associated with the vaccine. It will be clearly emphasized”, emphasizes, end, Marco Cavalieri.