The Norwegian Medicines Agency is unable to rule out the possibility that these cases may be linked to the AstraZeneca vaccine. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has decided that such cases should now be mentioned in the summary of product characteristics and the package information leaflet.
Important information for people who have been vaccinated: The AstraZeneca vaccine - When should a doctor be consulted?
How the rare cases are investigated
The Norwegian Medicines Agency and the European Medicines Agency (EMA) are continuing to review similar adverse reaction reports in Europe in order to see whether these cases could be linked to vaccination with the AstraZeneca vaccine. The Norwegian Medicines Agency reports all cases in Norway to the European Medicines Agency (EMA) and the WHO.
The unusual clinical picture involving blood clots, bleeding and low platelet counts has not been seen following vaccination with the other coronavirus vaccines used in Norway.
The Norwegian Medicines Agency, the Norwegian Institute of Public Health and Oslo University Hospital are now jointly conducting a thorough investigation into these cases.