Tuesday

13th Apr 2021

EU drugs agency plays down AstraZeneca 'blood clot' fears

  • Some 17 million people in the UK and the EU have already received the AstraZeneca jab (Photo: Cheshire East Council)

The European Medicines Agency (EMA) stressed on Tuesday (16 March) that the benefits of AstraZeneca's Covid-19 vaccine continue to outweigh the risks - after a dozen member states suspended its use in national inoculation programmes over blood-clot concerns.

"A situation like this is not unexpected when you vaccinate millions of people. Our role is to evaluate these so we can figure out is this a real side effect or is it a coincidence," EMA executive director Emer Cooke told a news conference.

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"At present, there is no indication that the vaccine has caused these conditions," she added, arguing that thrombosis cases reported are "very rare" events that need a "serious and detailed scientific evaluation",

The outcome of EMA investigation on whether there is a link between the vaccine and reported thrombosis cases is expected on Thursday afternoon.

"The experts will meet again on Thursday to come to a conclusion and to advise whether there are any further actions that need to be taken", Cooke said.

"We need to have the facts first, we cannot come to a conclusion until we have done a thorough scientific analysis and we owe it to the European citizens," she added.

Unease arose initially in Austria, which last week suspended the use of a batch of AstraZeneca vaccines after a nurse died of "severe blood coagulation problems" days after receiving the shot.

Danish and Norwegian authorities then decided to suspend all AstraZeneca vaccinations for two weeks.

They were followed by the Netherlands, Ireland, Bulgaria, Spain and Iceland.

After more reports of blood-clotting emerged on Monday, France, Germany, Italy, Portugal, Slovenia, and Cyprus also decided to suspended all AstraZeneca vaccinations.

Sweden and Latvia announced the same decision on Tuesday.

Belgium and other EU countries like Poland or Slovakia have decided not to pause vaccination with AstraZeneca, accusing others of suspending the jab use due to "panic".

"The side effects of stopping AstraZeneca vaccination are Covid-19 hospitalisations, long-term organ damage from Covid-19, and death from Covid-19," said Belgium virologist Marc Van Ranst.

The suspension of the AstraZeneca jab is expected to impact negatively the rollout of vaccines, but experts warned that these decisions might also undermine the trust of citizens in the vaccination process.

"We are worried that there may be an effect on the trust of the vaccines, but our role is to make sure that the products that we authorised are safe and can be trusted by European citizens," Cooke said.

Last week, the World Health Organization recommended that countries continue to use the Oxford-AstraZeneca vaccine.

As of 10 March 2021, there were just 30 cases of thromboembolic events reported among five million people vaccinated with AstraZeneca across Europe, EMA said.

Some 17 million people in the UK and the EU have already received the AstraZeneca jab.

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The European Commission said that bloc's strict regulatory process for the evaluation and approval of vaccines is crucial to persuade citizens to get the jab, calling on member states to fight vaccine hesitancy with information.

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The European Commission published a redacted version of the AstraZeneca contract - only for large parts to be uncovered by using the bookmark tool in Adobe Acrobat's Reader. "It was certainly not our intention for this to happen," it said.

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"The view that the company is not obliged to deliver because we signed a 'best effort agreement' is neither correct nor acceptable," said EU health commissioner Stella Kyriakides, after the company's CEO tried to justified delayed deliveries to the EU.

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A closer look at the events, however, shows that instead of a conspiracy the decision was old-fashioned bureaucratic caution. Isolated quotes by European officials were used to suit ideological agendas.

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