Norway, Sweden and Denmark will continue to pause on vaccines against AstraZeneca COVID-19 despite the European Medicines Agency’s (EMA) conclusion that the vaccine is “safe and effective”.
All three countries said they were reviewing the EMA verdict that the benefits of the vaccine outweigh its risks.
Their decisions fly against those of several other European nations. Italy, France, Germany and Spain said on Thursday they planned to restart vaccines against AstraZeneca following the EMA statement.
“Due to the various serious cases in Norway, we want to thoroughly review the situation before concluding,” said Geir Bukholm, director of the Infection Control Division at the Norwegian Institute of Public Health.
“This will take some time and we will provide an update by the end of next week,” he added.
The Swedish public health agency said its national regulator was investigating cases of blood clots in the country.
“[We] hopefully 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 “cases of severe but rare blood clots were observed after vaccination with AstraZeneca’s COVID-19 vaccine.”
They will hold a press conference on Friday to answer questions about the vaccine, but will continue to pause as they review the EMA assessment in the coming days.
Earlier Thursday, a Norwegian medical team said there was 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, a professor of hematology at Oslo University Hospital, a few hours before the EMA briefing.
“These patients had a potent immune response that caused the formation of antibodies that can affect platelets and therefore cause a blood clot,” he said, stating that he saw no other possibility but 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 review followed unconfirmed reports of an increase in the rate of blood clots among AstraZeneca vaccine recipients to see if there was a link.
“Its benefits in protecting people against COVID-19 with the associated risks of death and hospitalization outweigh the potential risks,” EMA Executive Director Emer Cooke told a news conference.
He described, however, that the regulator “cannot definitively rule out a link between these [blood clot] cases and the vaccine, ”saying the safety review committee would continue its investigations.
“We need to continually remember what situation we are in. This pandemic is costing our lives. We have safe and effective vaccines that can help prevent death and hospitalization. We need to use these vaccines in the environments we have.” , said Cooke.
The opinion of the EMA was long awaited at a time when the European Union, in short supply of vaccines, has 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 it was not an “unexpected” situation when millions of people get vaccinated and thousands of people produce blood clots every year.
“Our role at the EMA is to evaluate them, to make sure that any suspicion of adverse reactions is investigated quickly so that we can find out, is it a real side effect of the vaccine or is it a coincidence,” he said.