Germany, France, Italy and Spain have become the latest countries to suspend use of AstraZeneca’s Covid-19 vaccine over reports of dangerous blood clots in some recipients, but the company and global regulators have said there is no evidence the jab is to blame.
AstraZeneca’s is one of three vaccines in use on the continent, but the number of nations raising the alarm is another setback for the European Union’s vaccination drive, which has been plagued by shortages and other hurdles and is lagging well behind the campaigns in the UK and the US.
The EU’s drug regulatory agency called a meeting for Thursday to review experts’ findings on the AstraZeneca vaccine and decide whether action is needed.
The moves came as much of Europe tightened restrictions on schools and businesses amid surging cases of Covid-19.
Germany’s health minister said the decision to suspend AstraZeneca jabs was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven cases of clots in the brains of people who had been vaccinated.
“Today’s decision is a purely precautionary measure,” Jens Spahn said.
French President Emmanuel Macron said his country will suspend shots until at least Tuesday afternoon, Italy’s drug regulator announced a temporary ban, less than 24 hours after saying the “alarm” over the vaccine was unjustified, and Spain said it will stop using the vaccine for two weeks while experts review its safety.
Portugal and Slovenia have taken similar steps.
AstraZeneca is expected to apply for US authorisation of its vaccine in coming weeks. The US currently relies on Pfizer, Moderna and Johnson & Johnson vaccines.
AstraZeneca said there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country EU and the UK.
The drug maker said there is no evidence the vaccine carries an increased risk of clots, adding that the incidence is much lower than would be expected to occur naturally in a general population of this size, and is similar to that of other licensed Covid-19 vaccines.
The World Health Organisation and the EU’s European Medicines Agency have also said the data does not suggest the vaccine caused the clots and people should continue to be immunised.
“Many thousands of people develop blood clots annually in the EU for different reasons,” the EMA said. The incidence in vaccinated people “seems not to be higher than that seen in the general population”.
The agency said that while the investigation is going on, “the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects”.
Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 instances of pulmonary embolisms, or clots in the lungs.
Denmark last week became the first country to temporarily halt use of the AstraZeneca vaccine. It said one person developed clots and died 10 days after receiving at least one dose. The other countries include Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.
Canada, Britain and several smaller European countries are standing by AstraZeneca’s vaccine for now.