Denmark, Norway and Iceland have temporarily suspended the use of AstraZeneca's Covid-19 vaccine over concerns about patients developing post-jab blood clots, as the manufacturer and Europe's medicines watchdog insisted the vaccine was safe.
Denmark was first to announce its suspension, "following reports of serious cases of blood clots" among people who had received the vaccine, the country's Health Authority said in a statement on Thursday.
It stressed the move was precautionary, and that "it has not been determined, at the time being, that there is a link between the vaccine and the blood clots."
As of March 9, 22 cases of blood clots had been reported among more than three million people vaccinated in the European Economic Area, the European Medicines Agency (EMA) said.
Ban in other European countries
Austria announced on Monday that it had suspended the use of a batch of AstraZeneca vaccines after a 49-year-old nurse died of "severe blood coagulation problems" days after receiving an anti-Covid shot.
Four other European countries — Estonia, Latvia, Lithuania and Luxembourg — have also suspended the use of vaccines from this batch, which was sent to 17 European countries and consisted of one million jabs.
Denmark announced it has temporarily paused inoculations with the Oxford/AstraZeneca COVID-19 vaccine after several patients reported suffering from blood clots shortly after receiving the jab.https://t.co/33zj8bTgzv— New York Daily News (@NYDailyNews) March 11, 2021
Denmark, however, suspended the use of all of its AstraZeneca supply, as did Iceland and Norway in subsequent announcements on Thursday citing similar concerns.
On Wednesday, the EMA said a preliminary probe showed that the batch of AstraZeneca vaccines used in Austria was likely not to blame for the nurse's death.
"This is a super-cautious approach based on some isolated reports in Europe," said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.
"The risk and benefit balance is still very much in favour of the vaccine," he said.
AstraZeneca, an Anglo-Swedish company which developed the vaccine with Oxford University, defended the safety of its product.
"The safety of the vaccine has been extensively studied in phase III clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated," a spokesperson for the group told AFP.
Britain, whose widely praised vaccine rollout has been largely underpinned by the AstraZeneca jab, also defended it as "both safe and effective."
The Danish suspension, which will be reviewed after two weeks, is expected to slow down the country's vaccination campaign.
Denmark now expects to have its entire adult population vaccinated by mid-August instead of early July, the health authority said.
The UK is urging people to continue getting the Oxford vaccine after a number of countries have halted its rollout.— Evening Standard (@standardnews) March 12, 2021
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'Pausing its use'
"We are of course saddened by this news," said Prime Minister Mette Frederiksen.
Frederiksen, who has pushed for the production of more vaccines and has formed a controversial alliance with Austria and Israel to do so, defended the Danish health authority's decision.
"There is always a risk associated with vaccines," she told reporters.
"Things have gone well in Denmark, but there are some risks linked to the AstraZeneca vaccine that need to be examined more closely. That seems to me to be the right way to proceed."
Danish Health Authority director Soren Brostrom stressed that "we have not terminated the use of the AstraZeneca vaccine, we are just pausing its use."
"There is broad documentation proving that the vaccine is both safe and efficient," Brostrom said.
"But both we and the Danish Medicines Agency must act on information about possible serious side effects, both in Denmark and in other European countries."
Denmark said one person had died after receiving the vaccine. The EMA has launched an investigation into that death.
In the Scandinavian country of 5.8 million, around 25 percent of those who have received a first dose were given the AstraZeneca jab.
In total, 3.8 percent of the population has received two doses of vaccine and 13.4 percent at least one dose.
Italy bans AstraZeneca batch after two deaths
Italy's decision to ban a batch of AstraZeneca vaccine was taken following the deaths of two men in Sicily who had recently been inoculated, a source close to the matter said on Thursday.
Italy's medicines authority Aifa said earlier that the ban was a "precautionary" measure, adding that no link had been established between the vaccine and subsequent "serious adverse events."
The source said Aifa had moved after Stefano Paterno, a 43-year-old navy officer, died earlier this week of a suspected heart attack the day after his jab.
A second man, 50-year-old policeman Davide Villa, died last weekend, some 12 days after his jab. Local newspapers reported he fell ill within 24 hours of his injection and never recovered.
The source said both men had received shots from AstraZeneca's ABV2856 batch.
Britons told to keep getting vaccines
However, in the UK the medicine regulator urged Britons should keep on getting their Covid-19 vaccines, including the shot developed by Oxford and AstraZeneca, after Denmark and some other countries restricted their use of it.
Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) said it was not confirmed that the reported blood clot in Denmark was caused by the vaccine, adding that the Danish suspension was precautionary.
"Blood clots can occur naturally and are not uncommon," said Phil Bryan, MHRA Vaccines Safety Lead, adding that more than 11 million doses of the vaccine had been administered across the UK and that reports of blood clots were not greater than would have occurred naturally.
"We are keeping this issue under close review but available evidence does not confirm that the vaccine is the cause. People should still go and get their Covid-19 vaccine when asked to do so."
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