EU agency says AstraZeneca vaccine is ‘safe and effective’

A review by the EU’s medicines regulator has concluded the Oxford-AstraZeneca Covid-19 vaccine is “safe and effective”.

A woman is vaccinated against Covid-19 with the AstraZeneca vaccine in Genoa, Italy, 10 March 2021.
image captionGermany, France and Italy were among the countries to pause their rollouts of the vaccine as a precaution

The European Medicines Agency (EMA) investigated after 13 EU states suspended use of the vaccine over fears of a link to blood clots.

It found the jab was “not associated” with a higher risk of clots.

Italy announced it would resume using the jab on Friday while Sweden said it needed a “few days” to decide

It is up to individual EU states to decide whether and when to re-start vaccinations using the AstraZeneca vaccine.

The agency’s investigation focused on a small number of cases of unusual blood disorders. In particular, it was looking at cases of cerebral venous thrombosis – blood clots in the head. 

Decisions to suspend use of the vaccine sparked concerns over the pace of the region’s vaccination drive, which had already been affected by supply shortages.

Much of Europe is struggling to contain a surge in coronavirus cases.

The World Health Organization (WHO) on Thursday called on countries to continue using the vaccine, and is due to release the results of its own review into the vaccine’s safety on Friday. 

What did the EMA say exactly?

Emer Cooke, the agency’s executive director, told a news conference: “This is a safe and effective vaccine.”

“Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweigh the possible risks.” 

Emer Cooke
image captionMrs Cooke was speaking at an online news conference in Amsterdam

The EMA’s expert committee on medicine safety, Mrs Cooke said, found that “the vaccine is not associated with an increase in the overall risk of… blood clots”. 

But the EMA, she added, could not rule out definitively a link between the vaccine and a “small number of cases of rare and unusual but very serious clotting disorders”.

Therefore the committee has, she said, recommended raising awareness of these possible risks, making sure they are included in the product information. Additional investigations are being launched, Mrs Cooke added. 

“If it was me, I would be vaccinated tomorrow,” Mrs Cooke added. “But I would want to know that if anything happened to me after vaccination what I should do about it and that’s what we’re saying today.”

Why did European countries act?

Thirteen EU countries suspended use of the vaccine, after reports of a small number of cases of blood clots among vaccine recipients in the region.

Leading EU states said they had opted to pause their use of the drug as a “precautionary measure”.

“There were a few very unusual and troubling cases which justify this pause and the analysis,” French immunologist Alain Fischer, who heads a government advisory board, told France Inter radio. “It’s not lost time.”

In Germany, the health ministry also pointed to a small number of rare blood clots in vaccinated people when justifying its decision. It postponed a summit on extending the vaccine rollout ahead of the EMA’s announcement. 

Other countries, such as Austria, halted the use of certain batches of the drug, while Belgium, Poland and the Czech Republic were among those to say they would continue to administer the AstraZeneca vaccine.

Decisions to halt rollouts of the AstraZeneca vaccine were criticised by some politicians and scientists.

A spokeswoman for Germany’s opposition Free Democrats said the decision had set back the country’s entire vaccination rollout. German Greens health expert Janosch Dahmen, meanwhile, argued that authorities could have continued using the drug.

Dr Anthony Cox, who researches drug safety at the UK’s University of Birmingham, told the BBC it was a “cascade of bad decision-making that’s spread across Europe”.

What has AstraZeneca said?

The company says there is no evidence of an increased risk of clotting due to the vaccine.

It said it had received 37 reports of blood clots out of more than 17 million people vaccinated in the EU and UK as of 8 March.

These figures were “much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines”, it said.

Professor Andrew Pollard, director of the Oxford vaccine group which developed the Oxford-AstraZeneca jab, told the BBC on Monday that there was “very reassuring evidence that there is no increase in a blood clot phenomenon here in the UK, where most of the doses in Europe [have] been given so far”.

British Health Secretary Matt Hancock this weekurged people to “listen to the regulators” and to “get the jab”. 

Chart showing the number of countries using each vaccine. Updated 15 March.

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