EMA: The AstraZeneca vaccine possibly causes rare, serious symptoms – but remains authorised for use

08 April 2021

An expert committee formed by the EMA has now concluded that it is possible that the rare cases of blood clots combined with low levels of platelets and bleeding are caused by the AstraZeneca COVID-19 vaccine. It is maintained, however, that the benefits of using the vaccine still outweigh any possible risks.

Before Easter, the EMA concluded that it could not be ruled out that the very rare and unusual symptoms of blood clots in combination with low levels of platelets and bleeding were associated with the AstraZeneca COVID-19 Vaccine (Vaxzevria) – conversely, an association was not established either.

The EMA since formed a special expert committee to carry out further investigations of the possible connection between the vaccine and the symptoms in question. And now the expert committee has concluded that an association between the unusual symptoms and the AstraZeneca COVID-19 vaccine is possible.

However, the conclusion does not change the status of the AstraZeneca COVID-19 vaccine, which remains a vaccine authorised by the drug regulatory authorities because its benefits of preventing death and other health-related COVID-19 consequences still outweigh the possible risks in the form of known and possible side effects.

The EMA announces in a press release that the health-scientific assessment of whether to resume vaccination with the AstraZeneca vaccine will depend, inter alia, on the rate of infection and vaccine availability in the individual countries. In Denmark, the Danish Health Authority has put vaccination with the AstraZeneca vaccine on hold until 15 April.

As with all other vaccines, the EMA continues to monitor the AstraZeneca COVID-19 vaccine and will provide information on its safety and efficacy on a regular basis.

A total of 86 cases with unusual symptoms have so far been investigated in the EU, two of which in Denmark

More than 25 million people in the EU and the UK – including 150,000 people in Denmark – have been vaccinated with the AstraZeneca COVID-19 vaccine.

Several countries have reported cases of the unusual symptoms with blood clots in combination with low levels of platelets and bleeding in people vaccinated with AstraZeneca’s vaccine.

A total of 86 cases with the unusual symptoms have so far been investigated as part of the EMA’s review. Among these cases, there are 18 persons who have died.

The Danish Medicines Agency has received two Danish reports confirmed to involve the unusual symptoms. The two Danish cases and the similar cases reported in other countries mainly occurred within 14 days of vaccination. One of the cases in Denmark had a fatal outcome.

Read more:

Press release from EMA: AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets.

Danish Medicines Agency’s theme on the investigations of the AstraZeneca vaccine.