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They did not say how many reports of blood clots there had been, but Austria has stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.
“Both we and the Danish Medicines Agency have to respond to reports of possible serious side-effects, both from Denmark and other European countries,” the director of the Danish Health Authority, Soren Brostrom, said in a statement.
The vaccine would be suspended for 14 days, the health agency said. It did not give details of the Danish blood clot victim.
AstraZeneca and the European Medicines Agency (EMA) were not immediately available for comment.
The drugmaker said earlier this week its shots are subject to strict and rigorous quality controls and that there have been “no confirmed serious adverse events associated with the vaccine”. It said it was in contact with Austrian authorities and would fully support their investigation.
The EMA said on Wednesday there was no evidence so far linking AstraZeneca to the two cases in Austria.
It said the number of thromboembolic events – marked by the formation of blood clots – in people who have received the AstraZeneca vaccine is no higher than that seen in the general population, with 22 cases of such events being reported among the 3 million people who have received it as of March 9.
Four other countries – Estonia, Lithuania, Luxembourg and Latvia – have stopped inoculations from the batch while an investigation contines, the EU drug regulator said.
The batch of 1 million doses of the shot went to 17 EU countries.
The Danish Medicines Agency said it had launched an investigation into the vaccine together with corresponding agencies in other EU-countries as well as EMA.
“It is important to emphasise that we have not opted out of using the AstraZeneca vaccine, but that we are putting it on hold,” Brostrom said.
The agency said it had pushed back the final date for when it expects all Danes to have been fully vaccinated by four weeks to Aug. 15 as a result of the vaccine suspension.
