(GNB Desk): Norwegian officials said a total of 23 people had died in the country a short time after receiving their first dose of the vaccine.
Of those deaths, 13 were nursing home patients who were at least 80-years-old and were apparently related to the side effects of the vaccinations, according to health officials. Side effects of the vaccine may have contributed to severe reactions in frail, elderly people, according to the Norwegian Medicines Agency.
Health officials are looking more closely into the deaths of nearly two dozen people after receiving their first dose of the Pfizer COVID-19 vaccine in Norway.
“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences,” the Norwegian Institute of Public Health said. “For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”
The agency has investigated 13 of the deaths so far and concluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients. Although a direct connection between the Pfizer vaccine and these deaths is yet to be established.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly,” medical officials said.
Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer said in a statement. The agency found that “the number of incidents so far is not alarming, and in line with expectations,” Pfizer said.
Full statement from the Norwegian Medicines Agency as below:
Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail
23 deaths associated with covid-19 vaccination of which 13 have been assessed. Common adverse reactions may have contributed to a severe course in elderly people who are frail.
Publisert: 15.01.2021
All reports of suspected adverse reactions with fatal outcome following vaccination are carefully assessed.
– The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.
The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness – and included few participants over 85 years of age. In Norway we are 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. We 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 jointly assess 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.
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