EMA is aware that the Danish Health Authority has paused its vaccination campaign with COVID-19 Vaccine AstraZeneca. This was decided as a precautionary measure while a full investigation is ongoing into reports of blood clots in people who received the vaccine, including one case in Denmark where a person died. Some other Member States have also paused vaccination with this vaccine.
There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine. The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing. PRAC is already reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with COVID-19 Vaccine AstraZeneca.
The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population. As of 10 March 2021, 30 cases of thromboembolic events had been reported among close to 5 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.
EMA will further communicate as the assessment progresses.