EMA says AstraZeneca benefits outweigh risks as more countries halt use

A string of countries across Europe have temporarily halted AstraZeneca Covid-19 vaccinations until reports of blood clots are reviewed, a setback for inoculations across the continent that national authorities described as a difficult decision that was necessary due to an abundance of caution.

The European Medicines Agency said it was examining the reports in close co-operation with experts in blood disorders, the pharmaceutical company, and national medical regulators including that of Britain, where about 11 million doses of the vaccine have been administered.

“Vaccines for Covid-19 help to protect individuals from becoming ill, especially healthcare professionals and vulnerable populations, such as older people or those with chronic diseases,” the EMA said in a statement.

“While its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing Covid-19 . . . outweigh the risks of side-effects.”

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Despite the EMA's view that AstraZeneca vaccines can continue to be administered, a string of national regulators including in Germany, Spain, Italy, France, and the Netherlands followed Ireland, Denmark, Iceland and Norway in suspending the use of the jab.

Beyond Europe, Thailand, Indonesia and the Democratic Republic of the Congo also temporarily halted inoculations pending more information. The EMA is expected to issue its assessment on Thursday.

‘Safe and effective’

Amid fears that the suspensions might lead to people refusing to have the vaccine, Downing Street said the AstraZeneca jab “remains both safe and effective”. Prime minister Boris Johnson’s official spokesperson said there was “no evidence” that blood clots were any more likely to occur following vaccination.

Minister for Finance Paschal Donohoe said Ireland had halted use of the vaccine due to an “abudance of caution” and it was important that reports of adverse events were handled in “a transparent and clear way”.

“I absolutely understand the reaction of many citizens yesterday who were very eager to access this vaccine. We had many citizens, many elderly citizens, many citizens in Ireland with other health conditions that were awaiting this vaccine yesterday. But I believe the right decision has been made,” he told journalists following a meeting of the Eurogroup in Brussels.

“I believe any short term effects on economic activity that could be caused by what I hope is a temporary suspension of the use of one vaccine, I believe will be offset by the great prize of retaining confidence in how effective our vaccines are and an effective vaccination program in the weeks to come.”

Minister for Health Stephen Donnelly told RTÉ Radio’s Morning Ireland on Monday that he hopes the suspension of the vaccine’s use would be a “very short period”.

He said he had no hesitation in temporarily halting the administration of the product as the public wanted clinical leaders to take a “very safety-conscious, cautious approach”. Around 30,000 people who had been due to receive the jab this week would hopefully have their appointments rescheduled before then end of the month or early next month.

Frustration

Across the EU, the suspension caused frustration for people who had been expecting to receive a jab as it caused the cancellation of 43,000 appointments in the Netherlands alone, at a time when vaccination campaigns had been beginning to ramp up. In Rome, there were scenes of confusion as patients who had been queuing for vaccine appointments had to be turned away.

“We are all aware of the implications of this decision and we didn’t take it lightly,” German health minister Jens Spahn told journalists. “The decision today is purely precautionary. It is a purely technical and not a political decision.”

There had been seven possible cases of blood clots out of 1.6 million vaccinations in Germany, Mr Spahn said. Both in Germany and Norway, which was the first to suspend use of the vaccine, authorities said that the reports of blood clots were very rare but had occurred in a relatively short time period, which prompted a safety review.

Germany’s vaccine authority the Paul Ehrlich Institute said there had been a “conspicuous accumulation” of cases of a very rare cerebral vein thrombosis together with lack of blood platelets, known as thrombocytopenia and bleeding.

The EMA said that “many thousands” of people develop blood clots each year in the EU, and that the number of reports seen in vaccinated people “seems not to be higher than that seen in the general population”. As of March 10th, 30 cases of blood clotting had been reported among almost 5 million people who had received the AstraZeneca vaccine in Europe, the regulator said.

In France, President Emmanuel Macron said he hoped the suspension would be brief.

“The decision which has been taken out of precaution is to suspend vaccinating with the AstraZeneca vaccine in the hope that we can resume quickly if the EMA gives the green light,” Mr Macron told reporters.

But there were concerns that, whatever the outcome of the EMA’s review, the suspension could fuel hesitancy towards vaccines that is already particularly prevalent in France, potentially slowing efforts to emerge from the pandemic.

In the northern Italian region of Piedmont, local prosecutors announced they had seized a batch of 393,600 AstraZeneca shots following the death of a 57-year-old music teacher in unclear circumstances, in what they said was a precaution to prevent further inoculations “until we are completely sure” the death was not linked to receiving the vaccine.

Separately, magistrates in Sicily also ordered the seizure of a separate batch of AstraZeneca vaccines after reports of the sudden death of two men.