Multiple European countries have suspended giving doses of the Oxford-AstraZeneca COVID-19 vaccine while European Union regulators investigate whether the shot could be linked to reports of blood clots.
“We are in the middle of the largest and most important vaccination rollout in Danish history. And right now we need all the vaccines we can get. Therefore, putting one of the vaccines on pause is not an easy decision. But precisely because we vaccinate so many, we also need to respond with timely care when there is knowledge of possible serious side effects. We need to clarify this before we can continue to use the vaccine from AstraZeneca,” Soren Brostrom, director of the National Board of Health, said in the statement.
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Denmark announced a two-week suspension of the vaccine Thursday and was shortly joined by Iceland and Norway.
The suspensions come after numerous reports of blood clots in Denmark, including a fatal case.
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Danish Health Minister Magnus Heunicke said taking the vaccine offline was a “precautionary measure” and that the country was not drawing conclusions until the situation could be “thoroughly investigated.”
“It is important to emphasize that we have not opted out of the AstraZeneca vaccine, but that we are putting it on hold. There is good evidence that the vaccine is both safe and effective. But both we and the Danish Medicines Agency have to react to reports of possible serious side effects, both from Denmark and other European countries. It shows that the monitoring system works,” Brostrom said.
Iceland’s Assistant to the Director of Health Kjartan Njalsson said there were no widespread reports of blood clots in the country, but it is going to wait on data from the European Medicines Agency before moving forward with the vaccine.
“It’s the lack of data right now that concerns us,” Njalsson said.
The Norwegian Institute of Public Health issued the “pause” on the vaccine after the country reported one death as a result of blood clots. The agency said it had noted reports of blood clots shortly after patients received the vaccine, and concerns were “mainly in the elderly where there is often another underlying disease as well.”
The suspensions come a week after numerous EU countries paused the use of one particular batch of the AstraZeneca vaccine after a 49-year-old Austrian woman died of multiple thromboses, but authorities cautioned there was “no indication” the vaccine was behind the death.
“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 batch quality is being investigated,” the EMA said in a statement.
AstraZeneca defended its vaccine in a statement Thursday, saying patient safety was the company’s “highest priority” while noting that Phase III trials showed the vaccine was “well tolerated” by most people.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 Vaccine AstraZeneca. The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine is generally well tolerated,” the company statement said.
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The vaccine rollout has been particularly troublesome for AstraZeneca, which has fallen tens of millions of doses short of the deliveries it was supposed to make to countries in the European Union.
The limited supply led Italy to ban the export of 250,000 doses of the vaccine to Australia last week in the hope of protecting its national supply. France has considered a similar ban on vaccine exports.
