The reports do not contain any information which suggests that the current recommendations regarding use of the COVID-19 vaccines in Norway should be revised.
Awareness of allergic reactions
In a number of European countries, a number of cases of severe allergic reaction, including anaphylaxis, have been reported following vaccination. Such reactions are very rare and can occur with any vaccination, but have been observed more frequently than expected with mRNA vaccines against COVID-19. Severe allergic reactions usually develop rapidly, can be life-threatening and require immediate treatment. Preparedness for anaphylaxis is therefore a requirement at all vaccination sites.
No serious allergic reactions were detected in the major vaccine studies which form the basis for the temporary authorisation. The Norwegian and European medicines regulatory authorities are therefore monitoring this situation closely. In Norway, four serious allergic reactions have been reported following vaccination with Comirnaty.
“Experience to date may indicate that severe allergic reactions occur more frequently with mRNA vaccines than with other vaccines. Healthcare professionals should be aware of such reactions and the fact that they can also occur amongst the elderly, even if they are uncommon. Anaphylaxis preparedness is important and health professionals are encouraged to follow the vaccination guide with regard to observation time," says chief medical consultant Sigurd Hortemo.
Deaths among nursing home residents
Every day, an average of 45 people die in Norwegian nursing homes or other similar institutions. It is therefore expected that deaths will occur soon after vaccination, without there necessarily being any causal relationship to the vaccine. Norwegian health professionals have a low threshold for reporting and readily report incidents which occur with a temporal link to vaccination.
Staff levels at RELIS and the Norwegian Institute of Public Health were stepped up last week to enable reports of adverse reactions to be assessed more rapidly. So far, 56 reports of deaths have been assessed for nursing home residents who had been vaccinated.
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 Norwegian 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.