The Norwegian Institute of Public Health suspended vaccination with the AstraZeneca COVID-19 vaccine after we became aware of cases of serious suspected adverse reactions in Denmark and other European countries. Cases were also subsequently reported in Norway.
The reports of adverse reactions that we have received do not provide a basis for revising the current recommendations regarding vaccination with the Comirnaty (BioNtech/Pfizer) and Moderna COVID-19 vaccines.
Click here to go to an overview of reports of suspected adverse reactions
Most of the reports concern common adverse and expected reactions, such as pain at the injection site, headache, general malaise with fever, fatigue, nausea and pain in the body. These adverse reactions are known from the studies which formed the basis for the vaccine authorisations. These reactions normally appear on the first or second day after vaccination and last for around 2-3 days. The reactions can be unpleasant, and it is not uncommon to feel so ill that it is necessary to stay off work for a few days.
Reports concerning a combination of blood clots, bleeding and low platelet counts as of 18 March
Several countries have reported an unusual clinical picture involving a combination of blood clotting, low platelet count and haemorrhaging which has occurred in people 3-14 days following vaccination with the AstraZeneca COVID-19 vaccine. As of 18 March, five such cases had been reported in Norway, one of which concerns a death and the other four are being treated in hospital. One death following a brain haemorrhage has also been reported.
Further reading: Status of severe cases involving blood clots, bleeding and low platelet counts following vaccination
Typical cases have involved blood clotting in a vein which transports blood from the brain (venous sinus thrombosis), a low platelet count and bleeding in the brain. In other cases, blood clotting has been observed in other small or large veins.
The Norwegian Medicines Agency cannot rule out the possibility that this clinical picture is linked to the vaccination. The Pharmacovigilance Risk Assessment Committee (PRAC), under the European Medicines Agency (EMA), reviewed these rare, but serious cases at its meeting on 18 March. Read more about the PRAC's preliminary assessment.
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 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 Institute of Public Health is now analysing data from the registries to determine whether there could be any link between blood clots, bleeding and COVID-19 vaccination. However, as many of these incidents are very rare, we are also working with the other Nordic countries.
Oslo University Hospital, Rikshospitalet is conducting thorough investigations and providing assistance in connection with the assessments of whether there are any similarities between the few serious cases. '
How to report adverse reactions
Healthcare professionals are obliged to report suspected new, unexpected and serious adverse reactions as soon as possible. Staffing levels at the Norwegian Institute of Public Health (NIPH) have been strengthened, and RELIS is assisting NIPH in the assessment of reports, enabling them to be assessed more rapidly. It is important that healthcare professionals state the relevant batch number when reporting adverse reactions. Health professionals should be particularly aware if a vaccinated person has developed symptoms which may be compatible with a blood clot following vaccination.
The general population can report adverse reactions via helsenorge.no, but you should consult a doctor or other healthcare professional in the case of suspected serious or unexpected adverse reactions following vaccination.
Reports of adverse reactions following vaccination are followed up by the Norwegian Medicines Agency in partnership with the Norwegian Institute of Public Health and the regional medicines information and pharmacovigilance centres (RELIS). The Norwegian Medicines Agency is responsible for the National ADR Register, and exchanges adverse reaction data with the European Medicines Agency (EMA) and the World Health Organization (WHO). This provides us with a better basis for assessing causation and implementing measures to safeguard patient safety.