An expert group has assessed the causal link with vaccination following reports of deaths in the frail elderly. Some uncertainty is associated with the assessments, but a small number of the deaths are likely to be linked to the vaccine.
At the end of February, the expert group was set up in order to assess the first 100 reports of deaths amongst nursing home residents following vaccination with the Comirnaty (Biontech/Pfizer) vaccine. At the time, around 30,000 elderly nursing home residents had been vaccinated.
As the mortality rate in nursing homes is generally very high, it was expected that there would be deaths following vaccination. Nevertheless, the Norwegian Medicines Agency wanted an independent assessment of the deaths from geriatric specialists.
"Frail patients can benefit from vaccination because they are at great risk of serious illness and even death if they become infected with the COVID-19 virus. Nevertheless, the expert group believes that, for some of these frail patients, common adverse reactions may have contributed to a more serious course of their disease", says senior medical consultant Sigurd Hortemo.
The group was set up in order to review whether there was a causal link between vaccination and death in each case. The aim was to learn more about vaccination in the frail elderly.
As of 18 of May 2021, a total of 155 deaths have been reported following vaccination with the Comirnaty vaccine. Most reports concern elderly and very frail nursing home residents.
See the article published in the Journal of the Norwegian Medical Association
The expert group's conclusions:
- In the case of ten of the 100 reports, a causal link between vaccine and death was considered to be "likely", in 26 cases "possible", and in 59 cases "unlikely". None were considered to be "certain". The expert group considered five of the cases to be "unclassifiable".
- The group stresses that there is considerable uncertainty associated with the conclusions. Nevertheless, the group believes that, amongst very frail patients, there is a risk that adverse reactions to the vaccines could initiate a cascade of complications, which in the worst case scenario could lead to the earlier death of the patient.
- The group notes that nursing home patients generally have a short life expectancy. Even before vaccination, many patients were in a "downward spiral" and had a short life expectancy. The approach that was adopted was to assess whether or not the development of the disease was accelerated by vaccination.
The expert group's assessments and recommendations:
- For some very frail patients, a more thorough assessment of the benefits of vaccination could have been made. This particularly applied during the first few weeks after the vaccines had become available.
- Patients with a very short life expectancy have little to gain from being vaccinated. There is a genuine risk that the time of death will be brought forward and that the patient will suffer adverse reactions to the vaccine during the last days of their life.
- In the case of short life expectancy, the benefits of vaccination should be carefully assessed against the associated risks, and it may often be better not to vaccinate. In the opinion of the expert group, this is adequately discussed in the current version of the Norwegian Institute of Public Health's guidelines concerning COVID-19 vaccines.
- The risk of fatal consequences of adverse reactions to vaccines can probably be reduced through preventive measures such as good hydration, medication reviews and optimised treatment of comorbid conditions. In addition, vaccination should be deferred in the event of acute functional decline, e.g. due to concomitant (intercurrent) infection.