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NORWAY’S HEALTH REGULATOR has said that common side effects may have contributed to the deaths of 23 elderly people found to be frail after receiving the Covid-19 vaccine.
“It may be a coincidence, but we are not sure,” Steinar Madsen, medical director of the Norwegian Medicines Agency, told The BMJ. “There is no sure connection between these deaths and the vaccine.”
In a statement, the Norwegian Medicines Agency said 13 autopsies had been performed on those who had died and suggested that common side effects of mRNA vaccines, such as fever, nausea and diarrhea, may have contributed to their death.
“There is a possibility that these common adverse reactions, which are not dangerous for younger and fitter patients and are not unusual with vaccines, may exacerbate the underlying disease in the elderly,” Madsen said.
“We are not alarmed or worried about this, because they are very rare occurrences and occurred in very fragile patients with very serious diseases.”
The Norwegian government and the Norwegian Institute of Public Health have updated their Covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail. This means that doctors will now weigh the side effects of the vaccine for elderly and very frail patients against the risk of Covid-19 for the patient.
The large studies on the Pfizer-BioNTech vaccine did not include patients with unstable or acute illnesses, and they included few participants older than 85 years.
Norway has vaccinated more than 30,000 people in recent weeks; its health regulator said an average of 400 people die each week in nursing homes and long-term care facilities.
“In Norway, we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, so deaths are expected close to the time of vaccination,” the Norwegian Agency for Medicines said.
“All deaths that occur within the first days of vaccination are carefully evaluated.
We cannot rule out that adverse reactions to the vaccine that occur during the first days after vaccination (such as fever and nausea) may contribute to a more severe course and fatal outcome in patients with severe underlying disease.
As of Thursday, January 14, 23 reports of suspected deaths had been submitted to the Norwegian ADR health registry.
Several reports of suspected adverse reactions are received daily and are continuously evaluated.
Pfizer said in a statement to Bloomberg that it was working with the Norwegian regulator and that the number of incidents so far “is not alarming” and “is in line with expectations.”
Allergies
About one in 100,000 people in the US who received the Pfizer-BioNTech Covid-19 vaccine have had severe allergic reactions, health officials said while emphasizing that the benefits of immunization greatly outweigh known risks. .
The data comes from the US Centers for Disease Control and Prevention, which documented 21 cases of anaphylaxis after the administration of 1,893,360 injections reported from December 14 to 23.
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“This averages a rate of 11.1 cases of anaphylaxis per one million doses administered,” CDC senior official Nancy Messonnier told reporters.
By comparison, influenza vaccines cause about 1.3 cases of anaphylaxis per million doses administered, making the Pfizer vaccine’s rate of anaphylaxis approximately ten times higher.
Messonnier added that cases of anaphylaxis were still “extremely rare” and it is still in the best interests of people to get vaccinated, particularly in the context of the Covid-19 pandemic which is a much greater danger to their health.
“A good value proposition for someone to get vaccinated is their Covid risk and poor Covid results are still more than the risk of a severe vaccine outcome.”
“Fortunately, we know how to treat anaphylaxis and we have provisions in place to ensure that at vaccination sites, people administering the vaccine are ready to treat anaphylaxis,” he said.
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