Virginia Mayo/AP Photo
Norway, Sweden and Denmark will continue a pause on AstraZeneca COVID-19 vaccinations despite the European Medicines Agency (EMA) conclusion that the vaccine is “safe and effective”.
All three countries said they were reviewing the EMA verdict that the vaccine’s benefits outweigh its risks.
Their decisions fly in the face of those of several other European nations. Italy, France, Germany and Spain said on Thursday they planned to restart AstraZeneca vaccinations following the EMA’s declaration.
“Due to the several serious cases in Norway, we want to thoroughly review the situation before we make a conclusion,” said Geir Bukholm, Director of the Division of Infection Control at the Norwegian Institute for Public Health.
“This will take some time, and we will provide an update at the end of next week,” he added.
Sweden’s public health agency said their national regulator was investigating cases of blood clots in the country.
“[We] hope that next week we will be able to decide how best to use this vaccine in the future,” said Swedish epidemiologist Anders Tegnell.
In Denmark, the health authority said that there were “observed cases of severe but rare blood clots after vaccination with the COVID-19 vaccine from AstraZeneca.”
They will hold a press conference on Friday to answer questions about the vaccine but will continue to pause vaccinations as they review EMA’s assessment in the coming days.
Earlier on Thursday, a Norwegian medical team said there was a link between the AstraZeneca vaccine and blood clots.
“We have obtained results which may explain the clinical course of our hospitalised patients,” said Pål André Holme, a professor of haematology at Oslo University Hospital, a few hours before the EMA briefing.
“These patients had a powerful immune response which led to the formation of antibodies which can affect the platelets and thus lead to a blood clot,” he said, stating that he did not see any other possibility but that it was linked to the vaccine.
Norway, where some 120,000 people received a first dose of the AstraZeneca vaccine, has had six cases of serious side effects, two of which were fatal.
‘No increase in overall risk of blood clots’ — EMA
The European regulator’s safety review followed unconfirmed reports of an increased rate of blood clots among recipients of the AstraZeneca vaccine to see if there was a link.
“Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalisation outweigh the possible risks,” EMA executive director Emer Cooke said at a press conference.
She qualified, however, that the regulator “cannot rule out definitively a link between these [blood clot] cases and the vaccine,” saying the safety review committee would continue its investigations.
“We have to continually remind ourselves what a difficult situation we’re in. This pandemic is costing lives. We have vaccines that are safe and effective that can help prevent death and hospitalisation. We need to use those vaccines within the environments that we have them,” Cooke said.
The EMA committee “has concluded that there is no increase in the overall risk of blood clots with this vaccine,” said Dr Sabine Straus, chair of the EMA safety review committee, adding that there was no evidence of a batch issue.
However, she said, there were a few cases where “tiny clots developed in multiple blood vessels in the first 7-14 days after vaccination,” Straus said. There were also a few cases of clots in blood vessels draining blood from the brain, she added.
There were just seven cases of the tiny clots and eighteen cases of the other blood condition out of 20 million people vaccinated, according to EMA.
Halting vaccinations ‘will lead to deaths’ — drug safety expert
The opinion of the EMA was hotly anticipated at a time when the European Union, in the midst of a vaccine shortage, is counting on millions of doses of this vaccine developed by British-Swedish firm AstraZeneca.
The World Health Organization has also said there is no evidence the vaccine is to blame.
Euronews has heard from several experts over the past few days who have criticised the decision by countries to suspend use of the AstraZeneca vaccine.
“The downside of this [suspending the AstraZeneca shot] is that we will drive up vaccine hesitancy and thus decrease the amount of the population that will be finally vaccinated (…). Just even the pause in vaccination will lead to deaths,” said Anthony Cox, a reader in clinical pharmacy and drug safety at the University of Birmingham.
Following the EMA’s announcement, Italy said it would restart its rollout of AstraZeneca vaccinations on Friday. France, Germany and Spain and Germany also announced similar moves.
French government officials said Prime Minister Jean Castex would get the vaccine on Friday afternoon to show government confidence in the jab.