​​A year of monitoring adverse reactions

The Norwegian Medicines Agency was one of the first medicines authorities in Europe to start publishing weekly overviews of suspected adverse reaction when it published its first report back on 14 January 2021. Since then, we have published a total of 47 reports and news articles about suspected adverse reactions reported by health professionals and the general public. It has become apparent that there is a low threshold for reporting suspected adverse reactions following vaccination. Most of the reports we receive come from the general public, with around 75% of reports originating from this source.

“We are very grateful that both health professionals and the general public report to us when they suspect an adverse reaction following vaccination. This enables the authorities to monitor adverse reactions effectively and to implement measures when we consider it necessary,” says Unni Hjelmaas, Head of Unit at the Norwegian Medicines Agency.

Globally, almost 10 billion vaccine doses have been administered during the year, and it is believed that around 60% of the world's population have now received at least one vaccine dose. We have never learned so much about any other vaccine in such a short period of time before.

Click here to go to the summary report of suspected adverse reaction reports

What are benefits of monitoring adverse reactions?

The Norwegian Medicines Agency closely monitors signals of possible adverse reactions and reports new adverse reaction signals to the European Medicines Agency (EMA) and the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). PRAC then consider whether it is necessary to update the summary of product characteristics and the package leaflet for the vaccines concerned with new safety information.

The Norwegian Institute of Public Health continually monitors a wide range of diseases using data from the Preparedness Register to compare incidences amongst vaccinated and unvaccinated persons. Amongst the diseases being monitored are blood clots in the lungs, deep vein thrombosis, cardiac infarction and stroke. No link has so far been confirmed between the vaccines used in the Norwegian vaccination programme and the risk of any of these conditions.

A reporting system, not a counting system

Communication concerning reported adverse reactions is challenging, because such reactions are reported on the basis of suspicions. Even if an event is reported, we do not know whether the vaccine is the actual cause.

"It is a reporting system which aims to identify what we need to investigate further, not a counting system which tells us the actual number of cases of adverse reactions,” stresses Hjelmaas.

All reports are included in the summary report on reports of suspected adverse reactions, regardless of whether or not the event is believed to be linked to the vaccines. As a result, the figures cannot be used to assess causalities or determine how often an adverse reaction occurs.

Transparency is vital

Transparency and the provision of balanced information concerning the benefits and risks associated with the vaccines are important to ensure that people can trust the advice and recommendations that are issued by the authorities.

"We were prepared for the strong interest that the COVID-19 vaccines and adverse reactions would inevitably attract. In our communication, we have always been open about both what we know and what we do not know,” stresses Hjelmaas.

Unfortunately, we have found that figures from the adverse reaction reports have been used and taken out of context. In social media in particular, we have seen numerous examples of our information being misused and disseminated along with false information. We therefore urge the general public to be critical of the information sources they use and what they share with others.

Find out more about the summary of the year in the report​. This summary report also contains updated figures on reports of menstrual disorders, inflammation of the heart and adverse reaction reports concerning the 12-17 age group.

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