Denmark has put using AstraZeneca’s COVID-19 vaccine shots on hold for two weeks after reports of cases of blood clots forming, including one death in Denmark, Danish authorities said on Thursday.
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.
Malta’s government, in a statement (see further below) said that there were no adverse effects have been reported in Malta from a batch of the AstraZeneca Covid-19 vaccine. The Ministry of Health said on Thursday that the Malta consignment of the ABV5300 batch was used up several weeks ago.
READ UPDATE INCLUDING MALTA’S GOVERNMENT REACTION HERE
“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.
Apart from Denmark and Austria, four other countries – Estonia, Lithuania, Luxembourg and Latvia – have stopped inoculations from the batch while an investigation contines, the EU drug regulator said.
The Austrian case stemmed from AstraZeneca batch labelled ABV5300 comprised one million doses and had been delivered to 17 EU countries.
In all according to the EMA, batch number ABV5300 was distributed to to 17 EU countries: Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Poland, Spain, Sweden.
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.
The country’s health minister, Magnus Heunicke, tweeted: ‘The health authorities have, due to precautionary measures, suspended vaccination with AstraZeneca following a signal of a possible serious side effect in the form of fatal blood clots.
‘It is currently not possible to conclude whether there is a connection. We act early, it needs to be thoroughly investigated.’
Main Photo: The AstraZeneca vaccine at the Region Hovedstaden’s Vaccine Center in Bella Center in Copenhagen, Denmark. EPA-EFE/Liselotte Sabroe