For Ema, the benefits of AstraZeneca outweigh the risks but the verdict will be on Thursday

by time news

Time.news – The Ema, the European Medicines Agency, on which the spotlight of the whole continent is focused in these hours, seeks to resolve the doubts on the vaccine of AstraZeneca. He insists that there is currently “no evidence” of a link between thrombosis cases and vaccination. He asks to rely on science, di “maintain confidence in vaccines” and promises for “Thursday afternoon” a definitive word with “maximum transparency” on the future of the vaccination campaign, without excluding any response action.

The difficult task of chasing away the shadow of suspicion with the beacon of science and numbers has been entrusted to the executive director of the EMA, Emer Cooke. “We remain firmly convinced that the benefits of the AstraZeneca vaccine in the prevention of Covid-19, with the associated risk of hospitalization and death, outweigh the risks of these side effects, “he said in his presentation before addressing an hour of questions from reporters from around the world.

“Till today, there is no evidence that vaccination caused these conditions. They have not appeared in clinical trials and are not listed as known or expected side effects, “explained Cooke. And EMA experts, including thrombosis specialists, are now sifting through every medical record of suspected cases.” to statistics but also to physical analysis “, explained one of the members of the task force who supports Cooke in the enterprise.

“In clinical trials, both people who were vaccinated and people who received the placebo showed a very small number of blood clot developments. The number of thrombi and overall embolic events in vaccinated people it does not appear to be higher than that of the general population“, explained the director.

“I don’t need to remind all of you here today that the Covid-19 pandemic is a global crisis with a devastating social and economic impact on health and continues to be a major burden on EU health systems,” he warned. In short, we must not let ourselves be carried away by collective panic, with about fifteen countries, including Italy, Germany, France and Spain, who have already stopped the AstraZeneca vaccine as a precaution.

Cooke explained the complexity of the current review, also to respond to those who accuse – once again – the EMA of being too slow in making decisions. “Our experts are working tirelessly to evaluate these effects as soon as possible but facts are needed to give a scientific evaluation and give citizens an answer based on science “, he clarified. In these days doubts are not allowed, especially by those who have the last word.

We are evaluating every report, on a case-by-case basis, and our experts will meet again today to consider the additional information sent by the Member States. There will be another meeting on Thursday that will bring us to a conclusion and will allow us to understand what actions to take. “And at the moment nothing is excluded.” Even our actions will depend on the analyzes we are doing “, he specified.

“Our priority is to ensure that vaccines can be used safely in the European population: if that means a further warning, we will consider it. If we believe there is a problem that cannot be solved, we will make the necessary decisions,” he warned. .

“As of March 30th, 30 cases out of nearly 5 million vaccinated with AstraZeneca have been reported but I know that number is wrong because the data continues to arrive even now and it is difficult to give a precise number.”

Emer Cooke, Ema

Cooke did not want to go into details: “Initially the investigation was focused on some specific lots but the further reports excluded the direct link between these lots and the cases”; “Reports regarding other vaccines are also analyzed, including Pfizer and Moderna, but the focus is on AstraZeneca” and “there is a continuous exchange of data with regulators and Member States” as well as a “comparison with Great Britain” . The numbers provided are as of March 10: “Thirty cases of thrombosis out of nearly 5 million vaccinated, but it is certainly a wrong number because the reports keep coming “.

The priority of Cooke and EMA is one: “To be sure of the safety of the vaccine”. And to do this, you must first of all keep your nerve. “A situation like this is not unexpected: When you vaccinate millions of people, rare or serious episodes of disease are inevitable after vaccination.

“We are concerned that there may be an effect on vaccine confidence, but our job is to ensure that the products we have authorized are safe and that European citizens can trust.”

Emer Cooke, Ema

The role of the EMA is to investigate quickly so as to be able to understand if it is a real side effect of the vaccine or a coincidence “, clarified the director who has in the long curriculum tasks ranging from the Irish pharmaceutical industry to WHO. “We are concerned that there may be an effect on vaccine confidence, but our job is to ensure that the products we have authorized are safe and that European citizens can trust.” A trust that no one can afford to lose in the midst of a pandemic.

“We are doing this review following concerns” about adverse cases after vaccination with AstraZeneca against Covid-19. This was stated by the director of the EMA, Emer Cooke, at a press conference.

“Our priority is to make sure the vaccine is safe.” For the moment, he explained, “there are no indications that the vaccine caused these conditions, they have not emerged in clinical trials nor have they been indicated as known side effects.

Many thousands of people develop thrombosis every year in Europe from different causes“So the EMA’s ongoing evaluation was born to answer the question:” Is this a side effect or a coincidence? “, he explained.” We are evaluating events connected with all vaccines, “Cooke said, although” at the moment Cases have been reported on AstraZeneca “.

“We are concerned that there may be an effect on vaccine confidence, but our job is to ensure that the products we have authorized are safe and that European citizens can trust.”

Emer Cooke, Ema

“Our position” on the AstraZeneca vaccine “is that the benefits outweigh the risks“,” but serious concerns need a serious scientific evaluation “after which” it will be possible to answer the questions “.

“As of March 30th, 30 cases out of nearly 5 million vaccinated with AstraZeneca have been reported but I know that number is wrong because the data continues to arrive even now and it is difficult to give a precise number.”

Emer Cooke, Ema

“For the moment we have not found any effects linked to single lots, but we continue to investigate” even if “the events we are seeing now in Europe are linked to different lots and therefore it is unlikely that these (lots, ed) concern the events” in question.

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