AstraZeneca vaccine not linked to overall increased risk of blood clots, benefits outweigh risks, says Europe’s drug regulator

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European nations which paused AstraZeneca coronavirus vaccinations have announced they will be resumed after Europe’s drug regulator said the vaccine was not linked to an overall increased risk of blood clots, and that the benefits of use outweighed the risks.

The European Medicines Agency (EMA) also said it had found no quality or batch issues with the vaccine.

Concerns over the blood clots led more than a dozen European countries to suspend the use of the vaccine over the past week.

Vaccinations will restart in the coming days.

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 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 received the shot.

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, covering 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 is difficult to treat called cerebral venous thrombosis (CVT); and a sub-form known as cerebral venous sinus thrombosis (CVST).

The review said it looked “in extreme detail” at records of CVST cases and of another form of clotting known as disseminated intravascular coagulation, or DIC.

“Most of these occurred in people under 55 and the majority were women,” the final statement said.

Italy, France to resume vaccination rollout

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

On Thursday, Italy became the first to announce it was resuming its rollout of the AstraZeneca, followed by France and Germany.

In a news conference, Prime Minister Jean Castex said France would resume inoculations now that the European Medicines Agency had confirmed it was safe.

“I am confident public trust in the vaccine will be restored,” he said, adding that he would get the shot on Friday.

Boris Johnson holds up a vial. He is wearing goggles and a facemask.
Prime Minister Boris Johnson said the COVID-19 vaccines being rolled out in Britain were safe.(Reuters: Paul Ellis)

British Prime Minister Boris Johnson said he would also be receiving his vaccination on Friday.

“The Oxford jab is safe and the Pfizer jab is safe. The thing that isn’t safe is catching COVID, which is why it’s so important that we all get our jabs as soon as our turn comes,” Mr Johnson said at a news conference in Downing Street.

“As it happens I’m getting mine tomorrow, and the centre where I’m getting jabbed is currently using the Oxford/AstraZeneca vaccine … and that is the one I’ll be having.”

Germany’s Health Minister Jens Spahn confirmed on Thursday (local time) that the country was set to resume administering AstraZeneca vaccines on Friday.

Mr Spahn said the move to previously suspend the vaccinations was the correct one.

“Informed decision-making, informed vaccination, is important for confidence,” Mr Spahn said.

Spain, Portugal and the Netherlands said they would also resume AstraZeneca vaccinations next week.

UK regulator also backs vaccine

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

Millions of people in the UK have already received at least one dose of the AstraZeneca vaccine.

Britain’s medicines regulator said it was investigating five cases of CVST among recipients, but reaffirmed that the benefits 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 made 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.

Reuters/AP

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