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.
Many people are reporting common adverse reactions
Most of the reports concern common adverse reactions, such as pain at the injection site, general malaise with fever, fatigue, nausea and pain in the body. These usually appear on the first or second day after vaccination and last around 2-3 days. It is also common for reactions to become stronger with the second dose.
“Many people are experiencing stronger reactions than are commonly seen with the influenza vaccine, for example. The adverse reactions are known from the authorisation studies and these reactions are reflected in reports of adverse reactions from both healthcare professionals and the general public," says senior medical consultant Sigurd Hortemo.
Healthcare professionals are obliged to report suspected new, unexpected and serious adverse reactions. Staff levels at RELIS and the Norwegian Institute of Public Health have been stepped up to enable reports of adverse reactions to be assessed more rapidly.
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.
A total of 82 reports have so far been assessed concerning deaths following vaccination relating to elderly people in need of nursing care, most of whom were nursing home residents. Many people who have been vaccinated in this group are very frail. It is therefore to be expected that deaths will occur soon after vaccination, without there necessarily being any causal relationship to the vaccine. The reports on many of these deaths state that no link with vaccination is suspected and that the event was due to an underlying illness suffered by the patient. However, there is always a possibility that common adverse reactions to vaccines, such as fever and nausea, could have aggravated an underlying condition in frail patients.
In Norway, healthcare professionals readily report suspected adverse reactions and events which occur with a temporal link to vaccination. We therefore receive more reports of suspected deaths following the vaccination of frail elderly people than other countries in Europe. The Norwegian Medicines Agency is now working to establish an external group of geriatric specialists to look into these events in order to give us a better insight into any causal relationships.
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.