COPENHAGEN (Reuters) – Health authorities in Denmark, Norway and Iceland on Thursday suspended the use of AstraZeneca’s COVID-19 vaccine following reports of blood clots forming in some people who had been vaccinated.
Austria had earlier stopped using a bunch of AstraZeneca shots while investigating deaths due to coagulation disorders and an illness due to a pulmonary embolism.
However, European regulator EMA said that the benefits of the vaccine outweigh the risks and that it could still be administered.
Europe is struggling to accelerate the explosion of vaccines following the delay in delivery of Pfizer and AstraZeneca, even though an increase in cases amid a more contagious virus variant has caused new barriers in countries such as Italy and France.
Denmark suspended the shots two weeks after a 60-year-old woman, who received an AstraZeneca shot from the same group used in Austria, formed a blood clot and died, Danish health authorities said.
Their response has also been fueled by reports “of possible serious side effects” from other European countries.
“It is currently not possible to determine if there is a link. We are acting early, it needs to be thoroughly investigated,” Health Minister Magnus Heunicke said on Twitter.
The vaccine would be suspended for 14 days in Denmark.
“This is a warning decision,” Geir Bukholm, director of infection prevention and control at the Norwegian Institute of Public Health (FHI), told a news conference.
FHI did not say how long the suspension would last.
“We … are waiting for information to see if there is a link between the vaccination and this case with a blood clot,” Bukholm said.
Iceland stung the vaccine on Thursday as it awaits the results of an investigation by the EMA. Italy also said on Thursday that the use of an AstraZeneca bundle not used in Austria would be suspended.
Some health experts have said that there is little evidence that the AstraZeneca vaccine should not be administered, and that the number of cases of blood clots is similar to the number of such cases in the general population.
“The problem with spontaneous reports of suspected side effects on a vaccine is the huge problem of distinguishing a causal effect of a coincidence,” Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told Reuters said.
Evans added that COVID-19 disease is very strongly associated with blood clotting.
Phil Bryan, head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), said the reports of blood clots so far were no more than would naturally occur in the vaccinated population.
“Available evidence does not confirm that the vaccine is the cause,” he said.
More than 11 million doses of AstraZeneca’s vaccine have so far been administered across the UK.
In a statement, AstraZeneca said no evidence of an increased risk of pulmonary embolism or deep vein thrombosis was found in safety data of more than 10 million records, not even when subgroups were considered based on age, gender, production group or country of use.
“In fact, the observed number of these types of events is significantly lower in those who are vaccinated than would be expected among the general population,” he added.
The drugmaker said this week that there were “no confirmed serious side effects with the vaccine”. It said it was in contact with the Austrian authorities and would fully support their investigation.
The EMA, the EMA, said on Wednesday that so far there is no evidence linking AstraZeneca to the two cases in Austria.
It is said that the number of thromboembolic events – characterized by the formation of blood clots – in people who received the AstraZeneca vaccine was not higher than in the general population, with 22 cases reported among the 3 million people who received the shot. of 9 March.
EMA said it understood the decision was taken by Denmark and Norway as a precautionary measure.
Four other countries – Estonia, Lithuania, Luxembourg and Latvia – have halted vaccinations from the group while the investigation continues, the EMA said.
The group of 1 million doses went to 17 EU countries.
Swedish authorities said they had not found sufficient evidence to stop the vaccination with AstraZeneca’s sting.
“There is no evidence that the vaccine causes these types of blood clots,” Veronica Arthurson, head of medical safety at the Swedish Medical Products Agency, told a news conference.
The Danish Medicines Agency said it had launched an investigation into the vaccine along with similar agencies in other EU countries and the EMA.
So far, 138,148 Danes have been shot with AstraZeneca’s vaccine in a country of 5.8 million. The Nordic country, which also uses vaccines from Pfizer-BioNTech and Moderna, will receive 2.6 million doses of AstraZeneca in the coming months.
The health authority of Denmark has said that the last date for when the Danes will be fully vaccinated will be pushed back by four weeks to 15 August.
Spain said on Thursday that it had so far not registered any cases of blood clots related to AstraZeneca’s vaccine, and that the shooting would continue.
(Reporting by Nikolaj Skydsgaard and Jacob Gronholt-Pedersen in Copenhagen, and Victoria Klesty in Oslo; Additional reporting by Ludwig Burger in Frankfurt, Johan Ahlander in Stockholm, Crispian Balmer in Rome and Kate Kelland in London. Edited by Alex Richardson, Nick Macfie and Bernadette Baum)