© Reuters. AstraZeneca coronavirus vaccination in Copenhagen
By Nikolaj Skydsgaard and Jacob Gronholt-Pedersen
COVID-19 vaccine shots from AstraZeneca (NASDAQ 🙂 – Health officials in Denmark and Norway announced Thursday that they had temporarily suspended use of AstraZeneca (NASDAQ 🙂 's COVID-19 vaccine shots after reports of blood clots forming in some people who had been vaccinated.
The move came after Austria stopped using a series of AstraZeneca shots while investigating death due to coagulation disorders and illness due to pulmonary embolism.
Danish health officials said the country's decision to suspend the shots for two weeks was made after a blood clot formed in a 60-year-old woman in Denmark who received an AstraZeneca shot from the same batch used in Austria and died.
The Danish authorities said they had "responded to reports of possible serious side effects from both Denmark and other European countries".
"It is currently not possible to conclude whether there is a connection. We act early, it must be thoroughly investigated," said Health Minister Magnus Heunicke 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 press conference.
FHI did not say how long the suspension would last.
"We … are waiting for information to see if there is any connection between the vaccination and this case with a blood clot," said Bukholm.
Also on Thursday, Italy announced that it would suspend use of the AstraZeneca batch used in Austria.
Some health professionals said there was little evidence that the AstraZeneca vaccine should not be given and that the incidence of blood clots was equivalent to the rate of such incidences in the general population.
"This is an extremely cautious approach based on some isolated reports in Europe," Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told Reuters.
"The problem with spontaneous reports of suspected vaccine side effects is the tremendous difficulty in distinguishing a causal effect from a coincidence," he said, adding that COVID-19 disease is very closely related to blood clotting.
AstraZeneca told Reuters on Thursday in a written statement that the safety of its vaccine had been extensively studied in human studies and peer-reviewed data had confirmed that the vaccine was generally well tolerated.
The drug company said earlier this week that its recordings have undergone rigorous quality controls and that "no confirmed serious adverse events related to the vaccine" have occurred. She said she was in contact with the Austrian authorities and would fully support her investigation.
The European Union's medicines agency, the European Medicines Agency (EMA), said on Wednesday that there was no evidence so far that could link AstraZeneca to the two cases in Austria.
It is said that the number of thromboembolic events – characterized by the formation of blood clots – is no higher in people who received the AstraZeneca vaccine than in the general population. 22 cases of such events have been reported among the 3 million people who received it as of March 9th.
EMA was not immediately available for comment on Thursday.
Four other countries – Estonia, Lithuania, Luxembourg and Latvia – have suspended vaccinations from the batch while investigations continue, the EMA said.
The batch of 1 million cans went to 17 EU countries.
The Swedish authorities said they had not found sufficient evidence to stop vaccination with AstraZeneca's vaccine. Sweden has identified two cases of "thromboembolic events" related to the AstraZeneca vaccine and approximately ten cases for the Pfizer BioNTech vaccine.
"We see no reason to revise our recommendation," said Veronica Arthurson, head of drug safety at the Swedish Medical Products Agency, at a press conference. "There is nothing to suggest that the vaccine causes these types of blood clots."
Spain said Thursday it has not yet registered any cases of blood clots related to AstraZeneca's vaccine and will continue to administer the shots.