Norway, Sweden and Denmark will continue to interrupt vaccinations against AstraZeneca COVID-19, despite the European Medicines Agency (EMA) finding that the vaccine is “safe and effective”.
All three countries said they were reviewing the EMA’s assessment that the benefits of the vaccine outweigh the risks.
Their decisions run counter to those of several other European countries. Italy, France, Germany and Spain said on Thursday that they planned to restart AstraZeneca vaccinations following the EMA statement.
“Because of the several serious cases in Norway, we want to look at the situation thoroughly before drawing a conclusion,” said Geir Bukholm, Director of the Infection Control Department at the Norwegian Institute of Public Health.
“This will take a while and we will provide an update at the end of next week,” he added.
The Swedish Public Health Service said their national regulator was investigating cases of blood clots in the country.
[We] I hope that next week we can decide how best to use this vaccine in the future, ”said Swedish epidemiologist Anders Tegnell.
In Denmark, the health authority said that “cases of serious but rare blood clots had been observed following vaccination with AstraZeneca’s COVID-19 vaccine.”
They will hold a press conference Friday to answer questions about the vaccine, but will continue to pause vaccinations as they review the EMA’s review in the coming days.
Earlier on Thursday, a Norwegian medical team said there is a link between the AstraZeneca vaccine and blood clots.
“We have obtained results that can explain the clinical course of our hospitalized patients,” said Pål André Holme, professor of hematology at Oslo University Hospital, a few hours before the EMA briefing.
“These patients had a powerful immune response that led to the formation of antibodies that could attack the platelets and lead to a blood clot,” he said, stating that he saw no other possibility than that it was related 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.
Vaccines ‘help prevent death and hospitalization’ – EMA
The European regulator’s safety assessment followed unconfirmed reports of increased blood clots among AstraZeneca vaccine recipients to see if there was an association.
“Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the potential risks,” EMA director Emer Cooke said at a news conference.
However, she qualified that the regulator “cannot definitively rule out a link between the two [blood clot] cases and the vaccine, ”said the safety assessment committee would continue its investigation.
“We need to constantly remind ourselves of what difficult situation we are in. This pandemic is costing lives. We have vaccines that are safe and effective that can help prevent death and hospitalization. We need to use those vaccines in the environments that we’ve got them, ”Cooke said.
EMA’s advice was hotly anticipated at a time when the European Union, amid a vaccine shortage, is counting on millions of doses of this vaccine developed by the British-Swedish firm AstraZeneca.
The World Health Organization has also said there is no evidence that the vaccine is to blame.
Cooke said earlier that this was not an “unexpected” situation in which millions of people are vaccinated and thousands have blood clots every year.
“Our role at the EMA is to evaluate these, to ensure that any suspected side effects are investigated promptly so that we can find out if this is a real side effect of the vaccine or is it a coincidence,” she said.