Sweden, Norway, and Denmark will maintain their suspension of AstraZeneca’s COVID-19 vaccine as they review the European Medicines Agency’s (EMA) conclusion that the jab is safe and effective.
The three Nordic countries will continue to review the judgment that the EMA released on Thursday that the benefits of the vaccine outweigh its rare risks.
Sweden’s Public Health Agency on Thursday said it was reviewing the EMA’s conclusion in consultation with the country’s Medical Products Agency.
Some cases of severe blood clots and severe coagulation disorders — blood clots and bleeding combined — have been reported in the country, and are under investigation by the Medical Products Agency.
“It is very sad that young healthy people have become so seriously ill and that we have also seen deaths after vaccination. These cases are rare but very serious,” said Audun Haga, the director of the Norwegian Medicines Agency, in a statement.
Haga added that the agency “believes that we cannot rule out that these cases may have a connection with the AstraZeneca vaccine.”
In a statement from the Danish Medicines Agency, Tanja Erichsen, acting director of Pharmacovigilance, said health authorities decided to investigate whether these rare but serious cases could be an adverse reaction to the AstraZeneca vaccine.
“The symptoms are unusual and they appear right after the vaccinations. It is our job to react to such cases. It is important that we together with EMA and the other drug regulatory authorities take our time to evaluate this type of reports thoroughly,” she added.
On the other hand, Italy, France, Germany, and Spain on Thursday said they would resume administering the AstraZeneca jab after the EMA’s decision.
The EMA on Thursday asserted that the use of the AstraZeneca vaccine against COVID-19 was safe.
“This is a safe and effective vaccine, its benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the possible risks,” Emer Cooke, the EMA executive director.
“When you vaccinate millions of people, it is inevitable that rare incidents happen,” she told a press conference.
However, the EMA head warned that a link between the reported cases and vaccine could not be ruled out definitively, so the agency would carry out further investigations and recommends raising awareness of possible risks.
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