“We try to get a clear picture of what is happening, to define precisely this syndrome induced by vaccination. Among vaccinees, there are more cases of venous thrombosis in the cerebral cavernous sinus in younger people than would be expected. We have to say this, ”said Marco Cavaleri to the Italian newspaper.
The PUBLIC contacted the EMA headquarters, looking for a reaction to these statements. A spokeswoman for the European agency just underlined that “the Pharmacovigilance Risk Assessment Committee has not yet reached a conclusion and the analysis is currently underway”. A decision is expected on Wednesday or Thursday, he said, which will be communicated through a press conference.
The evaluation work “is far from being completed”, acknowledged Marco Cavaleri. “This week we will start to have preliminary conclusions, but we will hardly get to give indications of age limits for the administration of the vaccine, as did several countries”, he warns. This is because the EMA is a regulatory agency and they would need to have very accurate data “on the risk-benefit ratio” to make such a recommendation. That role, he says, could be left to national public health agencies, which “manage vaccination campaigns and have several options at their disposal, which they can use as they see fit.”
Dozens of thromboembolic events have been reported in Europe, with some resulting in death. In the UK, it was learned this Easter, there were 30 cases and seven deaths out of a total of about 18.1 million doses administered by March 24. On March 31, the EMA reported that 62 cases had been recorded (in a count until the 22nd), among 9.2 million people who took a dose of the AstraZeneca vaccine in the European Union and also in Iceland, Liechtenstein and Norway, countries that, with the European Union, make up the European Economic Area.
So far, the EMA has always stressed that “no causal relationship with the vaccine has been proven”, although without excluding the possibility that it will be found. Some mechanisms have been suggested, such as thrombocytopenia (platelet reduction) induced by taking the anticoagulant drug heparin, and the EMA should look at all of these contributions this week.
The EMA also reiterates the message that the benefits of vaccination against the SARS-CoV-2 virus outweigh any risks – which Marco Cavaleri also confirms. “But let’s look more closely at each age group. Young women, who have been the protagonists of these thrombosis, suffer less from the effects of covid-19, we must make a risk-benefit assessment for them. But without forgetting that sometimes they also end up in intensive care with covid-19 – it takes meticulous work to understand whether the risk-benefit ratio is favorable at all ages ”, said the head of the EMA in this interview, quoted by the Italian news agency Loop.
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