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AstraZeneca has said there is no increased risk of blood clots from its COVID-19 vaccine, as the Netherlands and Ireland joined a fast-growing list of European countries suspending inoculations.
In a statement late on Sunday, AstraZeneca AZN, +0.66% said it had reviewed data from 17 million people vaccinated in the European Union and the U.K. with its shot, which was developed in collaboration with the University of Oxford.
The review “has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” said the Anglo-Swedish drug manufacturer.
It said there had been 15 events of deep vein thrombosis and 22 events of pulmonary embolism reported among those vaccinated. “This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines,” the company said.
“ A careful review of all available safety data of more than 17 million people vaccinated in the European Union and U.K. with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country. ”
Shares in AstraZeneca, which have fallen by 5.17% so far this year, were flat in London morning trading on Monday.
AstraZeneca’s statement comes after the Netherlands and Ireland joined several other European countries, including Denmark, Norway and Iceland, in pausing the use of the AstraZeneca–Oxford vaccine, following reports of blood clots, despite a lack of evidence the shot was responsible.
Other countries, including Italy and Romania have stopped using shots from one particular batch, while Austria has also halted use of doses from a single, but different, batch.
The Dutch government said on Sunday that AstraZeneca’s vaccine won’t be used until at least March 29 as a precaution. “We can’t allow any doubts about the vaccine,” said Dutch Health Minister Hugo de Jonge, adding, “We have to make sure everything is right, so it is wise to pause for now.”
The Dutch medicines authority stressed that no link has been proven between the cases and the vaccine.
Read: Irish health officials recommend suspension of AstraZeneca vaccine amid blood clot reports
Hours earlier, Ireland said it would also temporarily suspend use of the AstraZeneca–Oxford vaccine, citing a review from Norway’s medicines agency that showed four new cases of “serious blood clotting in adults.”
Dr. Ronan Glynn, the Republic of Ireland’s deputy chief medical officer, recommended the vaccine stop being used for now, but added that it “has not been concluded that there is a link between the COVID-19 Vaccine AstraZeneca and these cases of blood clotting.”
On Saturday, Norwegian health authorities reported that three people who received the AstraZeneca–Oxford shot are being treated for severe blood clots and cerebral hemorrhages, but that they didn’t know if the cases are linked to the vaccine. The people, who were all of “younger” age, had a reduced number of platelets in their blood, said the Norwegian Medicines Agency in a statement.
The decisions by Irish and Dutch authorities come as the World Health Organization. which is investigating the reports, renewed its support of the AstraZeneca–Oxford vaccine, saying on Friday that countries should not stop using the shot over fears that it causes blood clots as there is no indication that this is true.
The European Medicines Agency — which is currently carrying out a review into incidents of blood clots — has also stressed that there is “currently no indication that vaccination caused these conditions” and has said the vaccine’s benefits continue to outweigh the risks.
Thailand, one of the first countries outside of Europe to suspend use of the AstraZeneca–Oxford shot last week due to concerns over its safety, said on Monday that it will start using the vaccine this week, with the prime minister and his cabinet set to be the first to receive the shot.
And Northern Ireland said it would keep using the AstraZeneca–Oxford vaccine after seeking advice from the U.K.’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
“We are aware of the action in Ireland,” said Dr. Phil Bryan, MHRA vaccines safety lead, in a statement. “We are closely reviewing reports but given the large number of doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause.”
Read: AstraZeneca is aiming to meet EU second-quarter COVID-19 vaccine targets, despite reports
The safety concerns have emerged against a backdrop of shortages of vaccines in the EU, including those made by Germany’s BioNTech BNTX, +0.66% together with its U.S. partner, drug company Pfizer PFE, +0.66%, because of manufacturing issues at some plants. The European Commission, the executive arm of the EU, boosted its vaccine supply in February when it announced it had struck a deal for an extra 150 million doses of the vaccine made by Moderna MRNA, -2.48% this year, nearly doubling the number of shots secured from the U.S. biotech for 2021.
The slow rollout of the EU’s immunization program has left several countries vulnerable to a spike in infections. Italy is set to begin a new lockdown on Monday in an effort to curb the spread of the virus, while Paris could also be facing tighter measures as cases rise.
AstraZeneca said in February that it is still aiming to supply 180 million doses of its COVID-19 vaccine to the European Union in the second quarter of the year.
