Europe’s drug regulator says the AstraZeneca vaccine is not linked to overall increased risk of blood clots

Davies

A needle balanced on a vial of the AstraZeneca vaccine

Europe’s drug regulator says the AstraZeneca vaccine is not linked to overall increased risk of blood clots, and that the benefits of use outweigh the risks.

Key points:

  • Blood clots have been reported in at least 37 people who received at least one AstraZeneca vaccine
  • More than 45 million of the shots have been administered across Europe
  • At least 13 European countries stopped administering the shot pending the review

The European Medicines Agency (EMA), of the European Union, also said they found no quality or batch issues with AstraZeneca’s COVID-19 vaccine.

The findings arrive after concerns over the blood clots led to more than a dozen European countries suspending the use of the vaccine over the past week.

Emer Cooke, head of the EMA, said the agency “cannot rule out definitively a link” between rare types of blood clots and the vaccine.

The EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware.

“Our scientific position is that is that this vaccine is a safe and effective option to protect citizens against COVID-19,” Ms Cooke said.

“It demonstrated at least 60 per cent efficacy in clinical trials [for] preventing coronavirus disease. In fact, the real-world evidence suggests that the effectiveness could be even higher than that.

The agency has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

Graph shows vaccine doses administered.

Graph shows vaccine doses administered.This graph shows the total number of vaccine doses administered per 100 people in the total population. March 17, 2021.(Our World in Data

)

Blood clots have been reported in at least 37 people, with four deaths recorded from more than 45 million who have received at least one dose of the AstraZeneca vaccine in the European Economic Area (EEA).

The agency’s review covers 5 million people, included 30 cases of unusual blood disorders in people in the EEA, which links 30 European countries.

The EMA’s focus and primary concern has been on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT) or a sub-form known as cerebral venous sinus thrombosis (CVST).

More than 45 million of the shots have been administered across the EEA.

At least 13 European countries, including France, Germany and Italy stopped administering the shot pending the review.

UK regulator also backs vaccine

A woman in a black face mask walks through Trafalgar Square

A woman in a black face mask walks through Trafalgar SquareThe UK has administered 11 million doses of AstraZeneca’s vaccine.(Reuters: Henry Nicholls

)

Britain’s medicines regulator said it was investigating five cases of CVST among people given AstraZeneca’s vaccine but it reaffirmed that the benefits of the shot far outweighed any possible risks.

The World Health Organization also this week reaffirmed its support for the shot.

Many governments have said the decision to pause inoculations was out of an abundance of caution.

But experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants.

The bloc’s vaccine roll-out has lagged the United States and former EU member Britain.

In Australia, the federal government says the rollout of the AstraZeneca vaccine will continue.

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