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Three European countries suspend use of Oxford/AstraZeneca vaccine
Denmark, Norway and Iceland halt injections as ‘precautionary’ move after woman died following jab
Danish, Austrian and EU authorities said it could not be concluded whether there was a link between the blood clots and the vaccine © AFP via Getty Images
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. 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.
All Denmark residents who have received the Oxford/AstraZeneca jab in the past two weeks will receive a letter from health authorities telling them about possible signs of blood clots and asking them to contact their doctors if they suffer any new or surprising symptoms.
Denmark has received doses from the batch that has been suspended in Austria, Estonia, Lithuania, Luxembourg and Latvia. It could not be immediately confirmed whether the 60-year-old woman in Denmark who died had been injected with a shot from that batch.
AstraZeneca, whose shares fell 2.5 per cent in early afternoon trading on Thursday in London, said patient safety was its “highest priority”.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes” its vaccine, the company 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, a 49-year-old woman died as a result of “severe coagulation disorders”, while another, 35, developed 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 ABV5300 batch consists of about 1m doses in total, the EMA said, and has been delivered to 17 EU countries. The European Commission said it would follow the EMA’s lead.
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.
Additional reporting by Michael Peel in Brussels and Sarah Neville in London
https://amp.ft.com/content/f9e5b8d8-8153-474a-bd57-97f5adbeb638
Denmark, Norway and Iceland halt injections as ‘precautionary’ move after woman died following jab
Danish, Austrian and EU authorities said it could not be concluded whether there was a link between the blood clots and the vaccine © AFP via Getty Images
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. 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.
All Denmark residents who have received the Oxford/AstraZeneca jab in the past two weeks will receive a letter from health authorities telling them about possible signs of blood clots and asking them to contact their doctors if they suffer any new or surprising symptoms.
Denmark has received doses from the batch that has been suspended in Austria, Estonia, Lithuania, Luxembourg and Latvia. It could not be immediately confirmed whether the 60-year-old woman in Denmark who died had been injected with a shot from that batch.
AstraZeneca, whose shares fell 2.5 per cent in early afternoon trading on Thursday in London, said patient safety was its “highest priority”.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes” its vaccine, the company 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, a 49-year-old woman died as a result of “severe coagulation disorders”, while another, 35, developed 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 ABV5300 batch consists of about 1m doses in total, the EMA said, and has been delivered to 17 EU countries. The European Commission said it would follow the EMA’s lead.
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.
Additional reporting by Michael Peel in Brussels and Sarah Neville in London
https://amp.ft.com/content/f9e5b8d8-8153-474a-bd57-97f5adbeb638
