Denmark announced a two-week suspension on Thursday after a series of reports of coagulation in the country, including a fatal case. Iceland and Norway followed suit, but did not say how long the suspensions would last.
Danish Health Minister Magnus Heunicke made it clear that the break was a “precautionary measure”, saying that it was not yet possible to draw conclusions.
“We acted early, this needs to be investigated thoroughly,” he said in a tweet.
The Danish Health Authority also emphasized that the decision was temporary.
“We are in the midst of the largest and most important vaccination launch in the history of Denmark. And now we need all the vaccines we can get. Therefore, pausing one of the vaccines is not an easy decision. But precisely because we vaccinate so many, we also need to respond with timely care when we are aware of possible serious side effects. We need to clarify this before we continue to use the AstraZeneca vaccine, “said Søren Brostrøm, director of the National Health Council in the statement.
“It is important to emphasize that we did not choose the AstraZeneca vaccine, but we are suspending it. There is good evidence that the vaccine is safe and effective. But we and the Danish Medicines Agency have to react to reports of possible serious side effects, both from Denmark and other European countries. This shows that the monitoring system works. “
Speaking to CNN Kjartan Njálsson, assistant to the Icelandic director of health, said that although there have been no reports of patients who developed blood clots in the country, they awaited the advice of the European Medicines Agency (EMA). “It is the lack of data now that concerns us,” he added.
The EMA said on Thursday that it did not recommend suspending the use of the vaccine.
The agency said it was aware that Denmark had suspended use, but that “there is currently no indication that vaccination has caused these diseases, which are not listed as side effects with this vaccine.”
“The benefits of the vaccine continue to outweigh its risks and the vaccine can continue to be administered while investigating cases of thromboembolic events is ongoing,” added the agency.
The EMA also noted that the number of blood clots seen in the vaccine recipients was not higher than the rate among people who had not received the vaccine in Europe.
The Norwegian Institute of Public Health issued a statement saying the country also chose to “pause” vaccinations after reporting a death in Denmark as a result of a blood clot. He also noted that there were reports of blood clots shortly after receiving the Covid-19 vaccination in Norway, but “mainly in the elderly, where there is often another underlying disease”.
The Spanish Public Health Commission announced Thursday that it was delaying vaccination of people between the ages of 55 and 65 with the AstraZeneca vaccine until “there is a complete review and conclusion of side effects by the European Medicines Agency (EMA)” , according to a commission statement issued on Thursday night.
Spanish Health Minister Carolina Darias called for calm on Thursday. “I would like to send a message of calm and caution. In Spain, we have not been notified of any cases related to blood clots,” Darias told the local TV station La Sexta.
The Public Health Commission includes the country’s Ministry of Health and representatives of Spain’s 17 regions.
AstraZeneca defends the safety of the shot
In a statement on Thursday, AstraZeneca said that patient safety was its “highest priority”.
“Regulators have clear and rigorous efficacy and safety standards for the approval of any new drug, and that includes the COVID-19 AstraZeneca vaccine. The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirm that the vaccine is generally well tolerated, “the company said in a statement.
In the United Kingdom, the Medicines and Health Products Regulatory Agency (MHRA) said that Danish authorities took a “precautionary measure” and advised people to get the vaccine when instructed.
The Dutch health minister also said there was no reason to stop using the vaccine.
“Our experts say there is no reason to worry, we can just keep vaccinating,” said Hugo de Jonge on Thursday.
Austria, Estonia, Lithuania, Luxembourg and Latvia have suspended the use of ABV5300 batch doses. Danish authorities did not specify whether the reported death was related to the same batch.
The EMA reported that the ABV5300 batch was delivered to 17 EU countries, comprising 1 million doses of the vaccine.
“Some EU countries have also subsequently suspended this batch as a precautionary measure, while a full investigation is ongoing. Although a quality defect is considered unlikely at this stage, the quality of the batch is being investigated,” the EMA said in a statement.
The investigation is the most recent problem in Europe for Swedish-British pharmaceutical company AstraZeneca, which is under pressure to produce more vaccines after reducing tens of millions of doses in deliveries to the European Union.
On Thursday, the Italian drug agency AIFA also banned the use of another batch of AstraZeneca vaccines. The agency said it was responding to “some serious adverse events” that occurred at the time of vaccinations for batch ABV2856. He did not say what the events were and said that no causal link between the events and the vaccine was established.
The company also faced resistance in the bloc, where regulators in member countries have been slow or hesitant to recommend the vaccine to people over 65, claiming a lack of data.
Regulatory bodies in several countries, including Germany and France, have since changed the recommendations to include more than 65 years old as real-world data has since shown that the AstraZeneca vaccine is highly effective in preventing hospitalization in older populations. France limits shooting to people under the age of 74.
Correction: an earlier version of this story reported that Italy has banned batch ABV5300. It has been corrected to show that Italy has banned a different batch from AstraZeneca due to concerns about unspecified adverse reactions.
CNN’s Angela Dewan contributed to this report.