Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations

11 March 2021

The Danish Medicines Agency together with the EMA and the other drug regulatory authorities in Europe have launched an investigation of the AstraZeneca vaccine after reports of blood clots in people given the vaccine. One report concerns the death of a person in Denmark. At present, there is no evidence to conclude that there is an association between the vaccine and the blood clots.

The European Medicines Agency, EMA, has launched an investigation of the AstraZeneca vaccine after reports of individuals having developed blood clots relatively shortly after vaccination.

Due to the temporal association, the drug regulatory authorities find that there is reason to investigate the circumstances further. The Danish Medicines Agency has received one report about a death in Denmark on the basis of blood clots. The case is being assessed. 

The Danish Health Authority has, based on a precautionary principle, put vaccinations with the AstraZeneca vaccine on hold in Denmark pending the results of the investigations.

“We do not know yet if the blood clots and the death reported in Denmark are related to the vaccine, but it should be thoroughly investigated as a precautionary measure,” says Tanja Erichsen, Head of Division, in the Danish Medicines Agency.

People who have been vaccinated with the AstraZeneca vaccine in the last 14 days and who experience long-term symptoms, i.e. lasting for more than three days, should talk to their doctor. Likewise, you should consult your doctor if you experience new symptoms within 14 days, after any common well-known transient symptoms occurring in the first days after vaccination have disappeared.

Vaccination paused in several countries

Six other European countries have now paused the use of a specific batch of the AstraZeneca vaccine while the investigations are ongoing.

Head of Division Tanja Erichsen encourages people who have received the AstraZeneca vaccine to stay calm.

“I understand if people are getting worried, but it is important to remember that there hasn’t yet been established a connection between the vaccines from AstraZeneca and the reported blood clots. This is what we’ll be investigating,” she says.

Further reading 

Press release from the EMA: COVID-19 Vaccine AstraZeneca:PRAC preliminary view suggests no specific issue with batch used in Austria.

Press release from the Danish Health Authority: Vaccination with the COVID-19 from AstraZeneca is put on hold until further notice.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...