European Medicines Agency director of vaccines said “there is a link” between the AstraZeneca formula and cases of thrombosis

An official from the European Medicines Agency (EMA) confirmed “a link” between the AstraZeneca vaccine and the thromboses recorded in people who received this vaccine, he assured this Tuesday in an interview with the Italian newspaper The messenger.

“Now we can say, it is clear that there is a link with the vaccine, which causes this reaction. However, we still do not know why (…) In summary, in the next few hours we will say that there is a link, but we have not yet understood why it happens“Said Marco Cavaleri, head of vaccine strategy at EMA.

“We’re going to say there is a connection, but we haven’t figured out why this is happening yet.”

The European authority must officially take a decision on this issue, Cavaleri said. The pharmacovigilance risk assessment committee (PRAC), responsible for monitoring and evaluating the safety of medicinal products for human use authorized by the EMA, has meetings scheduled from Tuesday to Friday, it is therefore planned to report on his assessment these days.

“We are trying to have a precise framework of what is happening, to define the syndrome due to the vaccine (…) Among those vaccinated, the number of cases of cerebral thrombosis in young people is higher than expected. That we will have to say“, He explained.

There have been concerns about possible serious, but rare, side effects in people vaccinated with AstraZeneca for several weeks. These would be cases of atypical thrombosis, some of them caused death. However, agency experts argue that among the elderly the benefit of the vaccine outweighs the risk, given the need to be immune to COVID-19.

In the UK, there are 30 cases and 7 deaths out of a total of 18.1 million doses administered through March 24.

For the EMA, “a causal link with the vaccine has not been demonstrated,” as executive director Emer Cooke explained several days ago. For the European agency, according to current scientific knowledge, “there is no evidence to support the restriction of the use of this vaccine in any population.”

For Paul Hunter, a specialist in medical microbiology at the University of East Anglia, interviewed by AFP, “the evidence points instead to the Oxford-AstraZeneca vaccine as the cause,” he said.

As a precaution, several countries have decided to stop giving this vaccine to certain age groups, including France, Germany and Canada.

For AstraZeneca, the benefits of the Anglo-Swedish laboratory’s antidote in the prevention of covid-19 outweigh the risks of side effects and assured Saturday that “patient safety” is its “main priority”.

In addition to the research carried out within the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA convened on March 29 a meeting of independent external experts from various medical specialties, in particular hematologists, neurologists and epidemiologists, who discussed specific aspects of the cases detected, seeking to identify risk factors and additional data to characterize observed thromboembolic events and define a potential risk, if applicable.

This review, which will also be part of the PRAC’s final report, also did not identify any specific risk factors, such as age, sex or a medical history of blood clotting disorders that could explain these rare cases of post-vaccination thromboembolism. ., but considering that there could be a risk, it was decided to continue the analysis.

“People who have been vaccinated should be aware of the remote possibility of these very rare types of blood clots. If they experience symptoms suggesting coagulation problems as described in the product information, they should seek immediate medical attention and inform healthcare professionals of their recent vaccination.», Underlined the EMA, in full evaluation.

(With information from AFP and EFE)

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