Coronavirus: currently no indication that AstraZeneca’s COVID-19 vaccine has caused thromboembolic events, review is ongoing at European level

date: 11/03/2021

The FAMHP is aware that, as a precautionary measure, Denmark has paused its vaccination campaign with AstraZeneca’s COVID-19 vaccine. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported after vaccination. The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than the number seen in the general population. There have been no such reports in Belgium for AstraZeneca’s COVID-19 vaccine.

The Danish Medicines Agency is reviewing AstraZeneca’s COVID-19 vaccine in cooperation with EMA and the medicine agencies of the other European Member States, following reports of blood clots shortly after vaccination. One death has been reported in Denmark. At this stage, no link has been established between the vaccine and the formation of blood clots.

Because of the short time lapse, the Danish authority considers that there are grounds for further review. As a precautionary measure, the Danish vaccination campaign with AstraZeneca’s COVID-19 vaccine has been paused until the results of the review are available. This decision was taken by the Danish Ministry of Health and not by the Danish Medicines Agency. The latter has not suspended the vaccine's marketing authorisation. In Iceland, the vaccination campaign with AstraZeneca’s COVID-19 vaccine has also been paused for the time being.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency is working on the matter. PRAC is reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination. The information available so far indicates that 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 the five million people vaccinated with AstraZeneca’s COVID-19 vaccine in the European Economic Area. More than eleven million doses of AstraZeneca’s COVID-19 vaccine have been administered in the United Kingdom. In the UK as well, the number of blood clots reported so far in vaccinated people is not higher than the number seen in the general population.

PRAC continues to assess thromboembolic events and other related conditions. EMA will further communicate as the assessment progresses.

In Belgium, 94 063 doses of AstraZeneca’s COVID-19 vaccine had been administered as of 8 March. To date, no cases of thromboembolic events or deaths have been reported in Belgium for this vaccine. In total, 1 707 side effects have been reported in Belgium for this vaccine. In more than 95% of the severe cases, expected reactions were due to reactogenicity (fever, fatigue, pain).

The safety of COVID-19 vaccines is of paramount importance and both the FAMHP and EMA continuously monitor whether the benefits outweigh the risks.
 

Last updated on 11/03/2021