Denmark officials have announced that they suspending the use of the coronavirus vaccine developed by AstraZeneca and the University of Oxford.
The Danish Health Authority said it would temporarily stop using the shot in its vaccination program as a precaution “after reports of severe cases of blood clots in people who have been vaccinated with the COVID-19 vaccine from AstraZeneca.”
“Against this background, the European Medicines Agency has launched an investigation into the AstraZeneca vaccine. One report relates to a death in Denmark. At present, it cannot be concluded whether there is a link between the vaccine and the blood clots,” the health authority said in a statement.
The announcement comes after a similar move in Austria at the start of the week, where authorities are investigating the death of one person and the illness of another after they received doses of the vaccine.
A spokesperson for AstraZeneca said the company was aware of the statement made by the Danish Health Authority that it’s currently investigating potential adverse effects related to the vaccine.
“Patient safety is the highest priority for AstraZeneca. 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,” AstraZeneca said in a statement.
Søren Brostrøm, director of the National Board of Health in Denmark, insisted that the 14-day suspension was a precaution while investigations took place.
“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,” he said.
Austrian health authorities suspended the use of batch ABV5300 of the AstraZeneca vaccine after a person was diagnosed with multiple thrombosis (formation of blood clots within blood vessels) and died 10 days after vaccination, and another was hospitalised with pulmonary embolism after being vaccinated.
“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.
It added that its safety committee was reviewing the issue and “investigating the cases reported with the batch as well as all other cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination.”
As of March 9th, “22 cases of thromboembolic events had been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area,” the EMA said.
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