Denmark, Norway and Iceland have suspended use of the Oxford/AstraZeneca vaccine in a “precautionary” move after a Danish woman died with blood clots following inoculation.
At least five other European countries have halted the use of a specific batch of the vaccine this week, after reports of blood clots sparked a safety probe from the European drugs watchdog, Financial Times reports.
Meanwhile, Italy’s drug regulator on Thursday said it had halted the use of another batch, ABV2856, after two deaths.
“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. Sweden’s medical products agency told local media it did not think there was ‘sufficient evidence’ to suspend the vaccine.
Italy’s regulator stressed that no causal link had been identified between the vaccine and the deaths, adding that it was working with the European Medicines Agency to probe the batch.
Despite the suspensions, the EMA said on Thursday that the vaccine’s benefits still outweighed the risks, and that the shot could continue to be administered while the incidents were investigated.
“The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population,” the EMA said, noting that 30 such cases had been reported among 5m inoculated people in Europe.
The UK’s Medicines and Healthcare products Regulatory Agency said it was keeping the issue under review. With more than 11m doses of the AstraZeneca vaccine administered in the UK, the “reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population,” it said.
Earlier on Wednesday the EMA had said there was no “specific issue” with the ABV5300 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 that batch.
“There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine,” it said.