the European Medicines Agency “has not yet reached a conclusion”

The distrust of him continues to grow, while he is suspected of being responsible for cases of thrombosis. While the European Medicines Agency (EMA) said on Tuesday April 6 that it was still evaluating whether AstraZeneca’s SARS-CoV-2 vaccine was potentially linked to the formation of rare blood clots, reported in several countries, in France, a new complaint against X was filed by the family of a man who died of “Multiple thromboses” after receiving a first injection of this product.

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  • The MEA “has not yet reached a conclusion”

This announcement came a few hours after an AEM official mentioned the existence of a “Link” between the AstraZeneca vaccine and the cases of thrombosis observed by its administration, in an interview with the Italian daily Il Messaggero published Tuesday.

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The AEM Safety Committee “Has not yet reached a conclusion and the review is currently underway”, tempered in a statement the agency based in Amsterdam. “We will communicate and organize a press briefing as soon as the examination is finalized”, added the European regulator, specifying that an announcement was expected Wednesday or Thursday.

“We can now say it, it is clear that there is a link with the vaccine. What causes this reaction, however, we don’t know yet. (…). To sum up, in the next few hours we will say that there is a connection, but we still have to understand how it happens ”, said Marco Cavaleri, head of vaccine strategy at AEM earlier.

The AEM announced on March 18 that the benefits of AstraZeneca’s vaccine continued to outweigh the risks and that its use remained safe, after the suspension of injections by several countries. The agency had explained, however, that there was a possible link to rare cases of blood clots and that it would release updated advice at its safety committee meeting this week.

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  • For the WHO, the risk-benefit balance weighs “largely” in favor of the vaccine

The risk-benefit balance continues to weigh “Widely” in favor of the use of the AstraZeneca vaccine, for its part reaffirmed, Tuesday, an official of the World Health Organization (WHO).

Explaining that experts were gathered this week to discuss a possible link between this vaccine and certain rare types of thrombosis, Rogerio Pinto de Sa Gaspar, WHO director in charge of regulation, insisted that in l current state of knowledge, the risk-benefit balance remained “Very largely positive”.

“These benefits are really very important in terms of reducing mortality among populations that are vaccinated”, he said during a WHO press briefing devoted to World Health Day, saying that experts and the media alike had ” too much “ tendency to focus on risks alone. “We need to restore the balance [de notre message] with the benefits of the vaccine “, he insisted.

  • New family complaint after the death of a loved one

In France, the family of a 63-year-old man who died in March in Haute-Savoie in “Multiple thromboses” after receiving a first injection of AstraZeneca vaccine, filed a complaint against X for ” manslaughter “, announced, Tuesday, the parquet of Annecy. “The complaint was submitted to me urgently this Tuesday morning”, confirmed Véronique Denizot, the public prosecutor of Annecy.

According to the regional daily The Dauphiné freed, which revealed the information, the complaint was registered by the gendarmes of Seynod, Friday April 2, a little more than two weeks after the death, on March 18 in Annecy, of this sixty-year-old who had just received the first injection. His relatives reported the tragedy to the National Agency for the Safety of Medicines and Health Products (ANSM), which ordered additional information to clarify the causes of his death.

This is not the first procedure targeting the vaccine from the Anglo-Swedish laboratory: a complaint against X was filed in Toulouse after the death of a 38-year-old woman and the Nantes public prosecutor’s office opened a preliminary investigation in following the death of a medical student. These complaints could be examined jointly by the Paris prosecutor’s office as part of a grouping. Otherwise, Mme Denizot left the door open to “Referral to an examining magistrate”.

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  • Oxford University Announces Pause for AstraZeneca Vaccine Trials in Children

The University of Oxford announced on Tuesday that it was suspending trials on children of the vaccine it has developed with the Anglo-Swedish laboratory AstraZeneca, pending the opinion of the Human Regulatory Agency. British Medicines and Health Products (MHRA).

“While there are no concerns regarding the safety of the pediatric clinical trial, we are awaiting further information from the MHRA on the rare cases of thrombosis that have been reported in adults, before proceeding with further vaccinations. in the test “, the British university said in a statement.

  • Dozens of cases identified, very rare deaths

For several weeks, suspicions have appeared on possible serious side effects, but rare, after the observation in people vaccinated with the product of AstraZeneca of cases of atypical thrombosis.

Dozens of cases have been identified, several of which have resulted in death. In the UK, there have been thirty cases and seven deaths out of a total of 18.1 million doses administered (report as of March 24).

As a precaution, several countries have decided to no longer administer this vaccine below a certain age, such as France, Germany and Canada. Norway and Denmark have suspended its use for now. For its part, AstraZeneca assured in March that there was “No evidence of aggravated risk” and affirmed on Saturday that “Patient safety” was his “Main priority”.

The World with AFP