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COPENHAGEN (REUTERS) – Health authorities in Denmark, Norway and Iceland suspended the use of AstraZeneca’s Covid-19 vaccine injections on Thursday (March 11) following reports of blood clots in some people who had been vaccinated.
Austria stopped using a batch of AstraZeneca injections while investigating a death from bleeding disorders and pulmonary embolism disease.
Still, the European drug regulator EMA said the vaccine’s benefits outweigh its risks and could continue to be administered.
Europe is scrambling to speed up the launch of a vaccine after delivery delays from Pfizer and AstraZeneca, even as a surge in cases amid a more contagious virus variant has prompted new lockdowns in countries like Italy and France.
Denmark suspended injections for two weeks after a 60-year-old woman, who received an injection of AstraZeneca from the same batch used in Austria, formed a blood clot and died, Danish health authorities said.
His response was also prompted by reports “of possible serious side effects” from other European countries.
“Currently it is not possible to conclude if there is a link. We are acting early, it must be investigated thoroughly, ”Health Minister Magnus Heunicke said on Twitter.
The vaccine would be suspended for 14 days in Denmark.
“This is a cautious 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 … await information to see if there is a link between vaccination and this case with a blood clot,” Bukholm said.
Iceland suspended jabs with the vaccine on Thursday while awaiting the results of an EMA investigation. Italy, also on Thursday, said it would suspend the use of a different batch of AstraZeneca than the one used in Austria.
Some health experts said there was little evidence to suggest that the AstraZeneca vaccine should not be given and that the cases of blood clots matched the rate of such cases in the general population.
“The problem with spontaneous reports of suspected adverse reactions to a vaccine is the enormous difficulty of distinguishing a causal effect from a coincidence,” Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told Reuters.
Evans added that Covid-19 disease was strongly associated with blood clotting.
Phil Bryan, director of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), said reports of blood clots so far did not exceed what would have occurred naturally in the vaccinated population.
“The available evidence does not confirm that the vaccine is the cause,” he said.
So far more than 11 million doses of the AstraZeneca vaccine have been administered in Great Britain.
AstraZeneca told Reuters in a written statement that the safety of its vaccine had been extensively studied in human trials and peer-reviewed data confirmed that it was generally well tolerated.
The drug maker said this week that there had been “no confirmed serious adverse events associated with the vaccine.”
He said that he was in contact with the Austrian authorities and would fully support their investigation.
The European Union’s drug regulator, the EMA, said on Wednesday there was no evidence so far linking AstraZeneca to the two cases in Austria.
He said the number of thromboembolic events, marked by the formation of blood clots, in people who received the AstraZeneca vaccine was no greater than that seen in the general population, with 22 cases reported among the 3 million people who received the vaccine. March 9.
The EMA said it understands that the decision by Denmark and Norway was taken as a precaution.
Four other countries – Estonia, Lithuania, Luxembourg and Latvia – have stopped vaccines from the batch while investigations continue, the EMA said.
The million-dose batch was shipped to 17 EU countries.
Swedish authorities said they did not find sufficient evidence to stop vaccination with the AstraZeneca vaccine.
“There is nothing to indicate that the vaccine causes these types of blood clots,” Veronica Arthurson, head of drug safety at the Swedish Medical Products Agency, told a news conference.
The Danish Medicines Agency said it had launched an investigation into the vaccine together with the relevant agencies in other EU countries and the EMA.
So far 138,148 Danes have received an injection with the AstraZeneca 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 Danish Health Authority said the final date for when it expects all Danes to have been fully vaccinated would be pushed back four weeks to August 15.
Spain said Thursday that it had not recorded any cases of blood clots related to the AstraZeneca vaccine so far and that it would continue to administer the injections.
The EU drug regulator approved Johnson & Johnson’s single-dose Covid-19 vaccine on Thursday.
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