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Xagena Newsletter

NoMA: COVID-19 vaccination associated with adverse drug reactions in elderly people who are frail

All reports of suspected adverse reactions with fatal outcome following COVID-19 vaccination are carefully assessed.
The reports have suggested that common adverse reactions to mRNA ( messenger RNA ) vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients.

The large studies on Comirnaty ( BioNTech / Pfizer ) did not include patients with unstable or acute illness, and included few participants over 85 years of age.

Norway is now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur.
In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.

All deaths that occur within the first few days of vaccination are carefully assessed.
Norwegian Medicines Agency ( NoMA ) cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination ( such as fever and nausea ) may contribute to more serious course and fatal outcome in patients with severe underlying disease.

The Norwegian Medicines Agency and the National Institute of Public Health ( NIPH ) are jointly assessing all reports of suspected adverse reactions.
As a result, the Norwegian Institute of Public Health has updated the COVID-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.

As of 14 January, 23 reports of suspected deaths have been submitted to the Norwegian ADR health registry.
The figures in the published report include the thirteen reports that have been assessed by the Norwegian Medicines Agency and the National Institute of Public Health.
Several reports of suspected adverse reactions are received on a daily basis and are continuously assessed. ( Xagena )

Source: Norwegian Medicines Agency, 2021