Denmark joined other European countries in suspending use of a batch of AstraZeneca Plc’s Covid vaccine due to safety concerns, in a further setback for the shot just as immunizations were ramping up.
Health Minister Magnus Heunicke said in a tweet that it’s a precautionary move, following “signals of a possible serious side effect in the form of deadly blood clots.” The European Medicines Agency has said it’s investigating but has found no evidence linking the vaccine to clotting.
Shares in AstraZeneca fell as much as 2.7%.
“The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine is generally well tolerated,” AstraZeneca said in a statement.
The suspension adds to the vaccine’s woes in Europe, where delayed deliveries have fueled a dispute between the European Union and the U.K., where AstraZeneca is based. The company’s shot has also faced questions over its efficacy, after trials results sowed confusion. A number of EU countries have reversed course on earlier restrictions on its use in the elderly amid new data showing its benefits.
The development in Denmark follows news from Austria, where authorities last weekend suspended the use of one batch of the vaccine after reports of a death and an illness among recipients. The EMA said on Wednesday that its safety committee is investigating the cases reported in Austria, but there’s currently no indication that the shots have caused blood clotting.
Denmark’s suspension represents a “super-cautious approach based on some isolated reports in Europe,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence.”
Estonia, Lithuania, Luxembourg and Latvia have also suspended use of shots from the batch in question, according to an EMA statement. Iceland has since said it will also put its Astra program on hold until more is known about the side effects.
Vaccines from the lot, totaling 1 million shots, have also been delivered to France, Bulgaria, Cyprus, Greece, Ireland, Malta, the Netherlands, Poland, Spain and Sweden, the EMA said.
Denmark’s decision follows reports of one Danish fatality, though authorities are stressing that it’s currently not possible to conclude that there’s a link to AstraZeneca’s vaccine. Still, the country will suspend use of the vaccine for two weeks, with a new assessment due in the week starting March 22.
“It’s important to underline that we haven’t abandoned the AstraZeneca vaccine,” the Danish Health Authority said in a statement. “But we’re pausing its use. There’s good documentation that the vaccine is both safe and effective.”
Prime Minister Mette Frederiksen said Denmark needs to “research this further. It is with regret that we receive this news and it’s too soon to say what it will mean for our vaccine timeline.”
Denmark has given more than 142,000 inoculations with the AstraZeneca vaccine, accounting for about one-quarter of all Danes who have received a first Covid shot.
A year ago, Denmark became one of the first EU nations to go into a lockdown and shut its borders, and it has stood out for its cautious approach to fighting the pandemic. That includes forcing its fur industry to exterminate the entire Danish mink population amid concerns the animals were spreading the virus.
Denmark has also been one of the EU leaders in vaccinations, giving 13 shots per 100 people, according to Bloomberg’s vaccine tracker.
-Bloomberg
