On 14th January, a report about 23 deaths reported in Norway in connection with vaccination among severely frail elderly people published by the Norwegian Medicines Agency has generated interest outside Norway. An English version was published on the 15th January.
The Norwegian Institute of Public Health (NIPH), in collaboration with the Regional Medicine Information and Pharmacovigilance Centres (RELIS), processes reports of suspected side effects after coronavirus vaccination on behalf of the Norwegian Medicines Agency.
"Fatal incidents among these severely frail patients following vaccination do not imply a causal relationship between COVID-19 vaccination and death," explains Dr Sara Viksmoen Watle, Senior Physician at the NIPH.
Reports of notified deaths
By 14th January, 43,740 people in Norway had been vaccinated against COVID-19. A large proportion of those vaccinated are nursing home residents. The Norwegian Medicines Agency reported that up to and including the 13th January, there had been 23 deaths reported in connection with vaccination, and that common side effects may have contributed to a severe disease course among severely frail elderly people.
“In order to be able to interpret this information, it is important to see the full picture. Nursing home residents are at very high risk of a severe disease course or dying from COVID-19, and have therefore been prioritised for vaccination. A large proportion of those who live in nursing homes have severe underlying conditions or are in the last stages of life. Life expectancy in nursing homes is relatively short and on average, more than 300 people die in Norwegian nursing homes every week,” says Dr Watle.
She explains that as of the 18th January, 48,680 people had been vaccinated in Norway. The majority will have mild or no side effects:
"When we vaccinate the eldest and sickest who often have several underlying conditions we expect high mortality in this population. Hence, we also expect deaths following vaccination. We do not yet know if these deaths are due to the vaccine or other causes, but we cannot exclude that common side effects may have led to a more severe course for some patients. The 23 deaths occurred within six days after vaccination. We will examine these events in relation to the expected number of deaths among the nursing home populations. The Norwegian Medicines Agency and the Norwegian Institute of Public Health are now carrying out in-depth analyses. So far, there are no statistical analyses that indicate that coronavirus vaccination has had an increased risk of death among those vaccinated," she concludes.
On 8th January, the NIPH emphasised that severely frail patients or patients with a short remaining life expectancy must be assessed individually, whether the benefit of vaccination outweighs the risk that they may not tolerate potential side effects. This principle applies for decision making on provision of all medical care for this patient group, and healthcare professionals are required to make these difficult assessments on a daily basis.
About 40,000 people live in Norwegian nursing homes. Most nursing home residents who choose to take the vaccine against COVID-19 will have been vaccinated soon.
About monitoring of side effects in Norway
In Norway, healthcare professionals and the public can report suspected side effects electronically. All reports, regardless of source, are registered in the same database, giving the Norwegian health authorities a rapid and good overview of all reported incidents. The Norwegian Medicines Agency conducts continuous analyses of the adverse event data to uncover unknown side effects and collaborates with the European Medicines Agency. The results of these analyses may lead to updates of product information with new side effects or precautions. The Norwegian health authorities also closely monitor the side effects of coronavirus vaccines and other medicines reported in other countries.
From the studies performed in connection with vaccines from BioNTech and Pfizer, the health authorities have good knowledge about common and less common side effects among people who are vaccinated. Rare side effects or side effects that only appear long after vaccination cannot be excluded. Most side effects were mild / moderate, occurring in the first days after vaccination, and had passed within a few days:
- Most vaccinated people have pain at the injection site.
- Other common side effects are fatigue, headache, muscle aches, chills, joint pain and fever. These side effects are more common after dose 2.
- Side effects are less common among the elderly than among younger adults.
In the vast majority of cases, the side effects were mild or moderate. Less than 5 per cent had more bothersome side effects that were harmless, but that impacted their daily life for the few days they lasted. This was more common after dose 2 and among younger people.
How to report side effects in Norway
Anyone who experiences unexpected, severe or prolonged symptoms that are assumed to be due to the vaccine should contact a doctor or other healthcare professional for assessment and advice.
Healthcare professionals have a duty to report serious or unexpected reactions that they suspect may be due to the vaccine. The public can also submit notifications via helsenorge.no.
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