The European Medicines Agency (EMA) today concluded that there is a "possible relationship" between AstraZeneca's covid-19 vaccine and the formation of "very rare cases" of blood clots, but insisted on the drug's benefits.
"The EMA has found a possible relationship [between AstraZeneca's vaccine] and very rare cases of unusual blood clots with low blood platelets," but "confirms that the overall benefit-risk remains positive," says the EU regulator. ) in a statement.
In particular, the EMA safety committee "concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria," AstraZeneca's new name for the vaccine, taking into account "all the evidence currently available" , adds the regulator, in an allusion to the investigation carried out in recent weeks.
Noting that "covid-19 is associated with a risk of hospitalization and death", the European agency adds that "the reported combination of clots and low blood platelets is very rare", hence "the overall benefits of the vaccine" from AstraZeneca " outweigh the risks of side effects'.
According to the EMA, 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic venous thrombosis were registered until 22 March, as well as 18 deaths, in a universe of about 25 million vaccinated in the EU, the European Economic Area and the United Kingdom.
AstraZeneca has been shrouded in controversy due to the emergence of blood clots in those vaccinated with its vaccine against covid-19, meanwhile called Vaxzevria, a situation that led some European countries to suspend its use and which was only overcome after the EMA had assured, in mid-March, that this was a safe and effective drug.
The European regulator has since been investigating the relationship between the vaccine and episodes of blood clots and death in people inoculated with the Vaxzevria vaccine.
As early as Tuesday, Marco Cavaleri, head of vaccination strategy at the EMA, had assumed the existence of a link between AstraZeneca's covid-19 vaccine and cases of thromboembolism after its administration, in an interview with the Italian daily Il Messaggero, statements that caused discomfort in the European Union.
Earlier, earlier this week, the EMA published an update on the drug and, in addition to disclosing the name change to Vaxzevria, indicated that "a warning about very rare specific blood clot events has been included in the product information."
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