Denmark and Norway temporarily suspended AstraZeneca COVID-19 vaccinations on Thursday after reports of blood clots among some recipients of the shot.
The two countries halted the AstraZeneca vaccinations, which are not currently authorized for use in the U.S., two weeks after a 60-year-old woman given the shot in Denmark died from a blood clot, Reuters reported.
The inoculation reportedly came from the same batch given to two people in Austria, one of whom died from coagulation disorders after receiving the vaccine while the other had a pulmonary embolism. Estonia, Lithuania, Luxembourg and Latvia have also stopped vaccinations from the batch amid the probes.
Danish officials said they had responded “to reports of possible serious side effects, both from Denmark and other European countries,” noting the AstraZeneca vaccine, developed in partnership with Oxford University, would be halted for 14 days.
“It is currently not possible to conclude whether there is a link,” Health Minister Magnus Heunicke tweeted, according to a Reuters translation. “We are acting early, it needs to be thoroughly investigated,”
Norway did not specify how long its suspension is expected to last.
Geir Bukholm, the director infection prevention and control at the Norwegian Institute of Public Health (FHI), called the move a “cautionary decision.”
“We … await information to see if there is a link between the vaccination and this case with a blood clot,” Bukholm said, according to Reuters.
An AstraZeneca spokesperson said patient safety is “the highest priority” and defended its human trial results and peer-reviewed data on its vaccine.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 Vaccine AstraZeneca,” the spokesperson said in a statement to The Hill. “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.
Earlier this week, AstraZeneca reported “no confirmed serious adverse events associated with the vaccine” during trials and said it was working with Austria in its investigation.
The European Medicines Agency, which regulates drugs for the European Union, said that there was no evidence connecting the vaccine to the cases, noting in a statement that the number of cases of blood clots among those who got the vaccine is not greater than the amount among general population.
The U.K.’s Medicines and Healthcare Products Regulatory called Denmark’s suspension “a precautionary measure,” as it has not been confirmed that the vaccine caused the blood clot in the woman in Denmark, and urged people to still get vaccinated.
The Food and Drug Administration (FDA) has authorized vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson for emergency use. AstraZeneca plans to file for emergency-use authorization with the FDA in the upcoming weeks after it receives results from a trial, according to HealthDay.
–Updated at 11:49 a.m.