Denmark has suspended use of the Oxford/AstraZeneca vaccine as a “precautionary principle” after one person died in the country with blood clots following inoculation.
At least five other European countries have halted the use of a batch of the jab, after reports of blood clots sparked a safety probe from the European drugs watchdog.
“Right now we need all the vaccines we can get, ” said Soren Brostrom, head of the Danish health authority. “Therefore pausing one of the vaccines is not an easy decision.”
Brostrom added: “Exactly because we are vaccinating so many, we also need to respond quickly when there is knowledge of possible serious side effects.”
Danish, Austrian and EU authorities said it could not yet be concluded whether there was a link between the blood clots and the vaccine.
Late on Wednesday, the European Medicines Agency said there was no “specific issue” with the batch used in Austria, where two clotting cases, including one death, had been reported after vaccination.
The medicines regulator said that, as of Monday, two other reports of thromboembolic cases had been received for the batch. It could not be immediately determined whether the Danish case was one of these. The EMA said that 22 clotting cases had been reported among the 3m Europeans immunised with that shot.
“There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine,” the EMA said.
The countries that have suspended use of the batch include Austria, Estonia, Lithuania, Luxembourg and Latvia.
AstraZeneca said patient safety is its “highest priority”.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes” its vaccine, it said.
“The safety of the vaccine has been extensively studied in phase 3 clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated,” it said.
No deaths have been attributed directly to any Covid-19 vaccination.
In Austria, one woman, 49, died as a result of “severe coagulation disorders”, while another, 35, developed a pulmonary embolism but was recovering, the Austrian Federal Office for Safety in Health Care said on Sunday. Both had received the vaccine beforehand, it said.
The batch consists of about 1m doses in total, the EMA said, and has been delivered to 17 EU countries.
The World Health Organization was in touch with the EMA over the issue, officials said.
Danish health authorities said that, in a “worst-case scenario” of no longer using AstraZeneca vaccines at all, it would take until mid-August to vaccinate its adult population, a month later than its previous forecast.