The elderly are at greater risk of serious illness if they become infected with the COVID-19 virus. The Norwegian Institute of Public Health and the Norwegian Government have therefore decided that the very elderly and nursing home residents should be the first to be offered the vaccine.
What do we know about the efficacy of the mRNA vaccines in the elderly over 85 years of age?
Two coronavirus vaccines, Comirnaty from BioNTec/Pfizer and Spikevax from Moderna, are currently available for use in Norway. These vaccines were developed using mRNA technology and have been granted Conditional Marketing Authorisation in the EU/EEA. Large clinical studies have shown around 95% protection against COVID-19 disease, and a high level of protection was found both in the 18-65 age group and in participants over 65 years of age.
However, the studies that formed the basis for the Conditional Marketing Authorisation included very few people over the age of 85. Therefore little is known about the level of protection in this age group. Since the efficacy was relatively similar across all age groups covered by the studies, it is still believed that the protection in elderly over 85 years of age will be similar to that of people over 65 years of age (extrapolation).
What do we know about adverse reactions amongst the elderly over 85 years of age?
The studies that formed the basis for the temporary authorisation of the vaccine included very few people over the age of 85. We therefore know little about adverse reactions in this age group. However, we assume that the adverse reactions will largely be the same as in those over 65 years of age.
Discomfort during the first few days after vaccination is common
The large clinical studies have shown that most people who receive mRNA vaccines experience discomfort, including pain at the injection site, lethargy, headache, muscle and joint pain, nausea and fever, the first few days following vaccination
Most people only experience discomfort, which passes in a couple of days. However, we cannot rule out that relatively mild adverse reactions such as lethargy, fever and nausea could contribute to a more serious course of their underlying disease in very frail patients.
Severe allergic reactions
Generally, the use of traditional vaccines is linked to approximately one severe allergic reaction for every million doses that are administered. Experience so far suggests that such severe allergic reactions occur more often after the mRNA vaccines. However, it is still very rare for such reactions to occur (approximately one severe allergic reaction per 100,000 doses being administered). The handling of allergic reactions is covered by the vaccination procedures that are followed and the vaccination staff is trained to handle such reactions.
Other adverse reactions
During the studies, there were a few more cases of muscle weakness on one side of the face (facial paralysis) amongst those receiving the vaccine than amongst those receiving placebo. The figures are small and it is still uncertain whether this reaction was due to the vaccine or other factors.
It is not possible to rule out the possibility that unknown adverse reactions could become apparent when the vaccines are administered to large groups of the population. The authorities are monitoring this closely.
Deaths have been reported amongst nursing home residents who have received the vaccine
The major studies did not include patients with unstable or acute conditions and included few participants over 85 years of age. When we vaccinate the very elderly and people with serious conditions, deaths will inevitably occur with a temporal relationship to the vaccination. The occurrence of deaths soon after vaccination is to be expected. In Norwegian nursing homes and other similar institutions, an average of around 400 people die every week.
All deaths occurring with a temporal relationship to vaccination undergo thorough assessment. We cannot rule out the possibility that adverse reactions during the first few days after vaccination (such as fever and nausea), could contribute to a more serious course of their underlying disease in very frail patients.
Are there any elderly or frail people who should not receive the vaccine?
The Norwegian Institute of Public Health and the Norwegian Government have decided that the elderly and sick people should be the first to be offered the vaccine. The aim is to prevent serious illness and death. There is reason to believe that the vaccines will provide good protection against serious and fatal COVID-19 disease in patients above 85 years of age, although no such cases have yet been documented, because few people over the age of 85 participated in the studies).
The treating physician, following an overall assessment and in consultation with the patient and relatives, must decide whether an individual patient should be advised to take the vaccine.
Two factors must be taken into account in this assessment. One is the life expectancy of the patient, as many nursing home residents have a short remaining life expectancy. The second is that for some of the frailest elderly people, common adverse reactions following vaccination, such as fever, general malaise and poor appetite, can aggravate their underlying disease.
The Norwegian Institute of Public Health has issued recommendations concerning this in the Vaccination Guide:
"For the vast majority of people who are elderly and frail, any adverse reactions to the vaccine will be more than offset by the reduced risk of becoming seriously ill from COVID-19. However, for the very frailest people, even relatively mild adverse reactions to the vaccine could have serious consequences. For those who have a very short life expectancy, the benefits of the vaccine may be marginal or even irrelevant. For very frail patients (e.g. corresponding to Clinical Frailty Scale 8 or higher) and terminally ill patients, it is recommended that the benefits versus the drawbacks of vaccination be carefully weighed up".