Headlights still on on the AstraZeneca vaccine and the correlations with the rare cases of thrombosis. Based on all the data currently available, the Safety Committee of EMA, the European Medicines Agency, is expected to issue a recommendation updated Wednesday afternoon, 7 April. But the words of Marco Cavaleri, head of Ema’s vaccine strategy, regarding “an association with the vaccine” of the thrombosis cases recorded so far have led to discussion and become a case. The EMA intervened by declaring that «the pharmacovigilance commission that assesses the risk (Prac) has not yet reached a conclusion. The review is in progress. We will hold a press conference as soon as the work is finished, tomorrow (Wednesday, ed) or Thursday ». Pending the pronouncement of the EMA, a meeting between AIFA technicians and the Ministry of Health on the possibility of other indications for the vaccine. The agenda of the Aifa Technical-Scientific Commission (CTS) does not include the AstraZeneca vaccine but it is possible that there will be an analysis on the new scientific evidence concerning the thrombotic events induced by the vaccine. Meanwhile, theBritish drug agency (MHRA) is considering, according to the newspaper “The Times”, whether to limit the use of the AstraZeneca vaccine in young people: The UK has recorded 7 deaths out of 18.1 million doses administered due to rare thrombus developed after the vaccine. The decision could be made by Tuesday.
The Covid situation in Italy and in the world
The Undersecretary of Health Pierpaolo Sileri Tuesday morning he said that “it is possible, for greater precaution, that the EMA indicates that for a certain category it is better not to use the AstraZeneca anti-Covid vaccine”: that is, the Ema “can identify subgroups of the population that have a common denominator for a higher level of risk, and evaluate the cause-effect relationship in these groups” in relation to the rare thrombotic events that have been reported. As for the possibility that the EMA will come to limit the use of the vaccine by excluding certain categories, “it is part of the pharmacovigilance processes and has already happened for many other drugs, starting with aspirin, for which, starting from the 1980s, a limit of use has been set for the age group of children under 12 for some adverse events ».
Marco Cavaleri, head of Ema’s vaccine strategy, interviewed by “Il Messaggero”, explained that “it is now increasingly difficult to state that there is no cause and effect relationship between vaccination with AstraZeneca and very rare cases of unusual blood clots associated with a low number of platelets” . The EMA is currently investigating the cases of thrombosis recorded in the under 55s, mostly women. Cavaleri explains that the evaluation work is still “far from being completed”, “this week we will begin to give preliminary definitions, but we will hardly be able to indicate age limits as various countries have done. For the simple reason that we are a regulatory agency and we must have very precise data on the risk-benefit ratio “, while” the public health agencies that manage the various vaccination campaigns have different options available and can use them as they see fit ” . When asked if it exists a link between thrombosis cases and the vaccine Cavaleri replied that according to him «we can now say, it is clear there is an association with the vaccine. What causes this reaction, however, we do not yet know. ” “In summary: in the next few hours we will say that the connection exists, but we still have to understand how this happens”.
On March 31, the executive director of EMA, Emer Cooke had said that “it is possible” but “it is not proven” that there is a link by age or gender between the rare events of thrombosis of the cerebral sinuses and the administration of the anti-Covid vaccine of Astrazeneca, that at the moment “there is no evidence” that justifies restrictions and that “the benefits outweigh the risks of side effects”. Before the pronouncement of the EMAGermany, on the basis of the indications of the national regulator, had suspended the administration of the vaccine of the Oxford house for the under 60s after 31 suspected cases involving in particular 29 women between 20 and 63 years old. On April 2, the Netherlands decided to temporarily limit vaccination with AstraZeneca to people over sixty after new reports of serious side effects.
April 6, 2021 (change April 6, 2021 | 16:32)