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Norway adjusts advice for Covid-19 vaccine after 23 deaths in elderly, frail people

Common vaccine side effects, such as a fever, nausea and diarrhoea, may have contributed to the deaths, a health regulator said.

Aspen Valley Hospital clinical pharmacist Kelly Atkinson organises empty vials of the Pfizer-BioNTech Covid-19 vaccine.
Aspen Valley Hospital clinical pharmacist Kelly Atkinson organises empty vials of the Pfizer-BioNTech Covid-19 vaccine.
Image: AP/PA Images

NORWAY’S HEALTH REGULATOR has said that common side effects may have contributed to the deaths of 23 elderly people who are frail after they received the Covid-19 vaccine.

“It may be a coincidence, but we aren’t sure,” Steinar Madsen, medical director of the Norwegian Medicines Agency, told The BMJ. “There is no certain connection between these deaths and the vaccine.”

In a statement, the Norwegian Medicines Agency said that 13 autopsies had been carried out on those who had died, and suggested that common side effects to mRNA vaccines, such as a fever, nausea and diarrhoea, may have contributed to their deaths.

“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,” Madsen said.

“We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”

The Norwegian government and the Norwegian Institute of Public Health has updated its Covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail. This means that doctors will now weigh up 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 included few participants over 85 years of age.

Norway has vaccinated over 30,000 people in the past few weeks; its health regulator said that 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, therefore it is expected that deaths close to the time vaccination may occur,” the Norwegian Medicines Agency said.

“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.

As of Thursday 14 January, 23 reports of suspected deaths have been submitted to the Norwegian ADR health registry.

Several reports of suspected adverse reactions are received on a daily basis and are continuously assessed.

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 “in line with expectations”.

Allergies

Roughly one in a 100,000 people in the US who received the Pfizer-BioNTech Covid-19 vaccine have had severe allergic reactions, health officials said while stressing that the benefits of immunisation greatly outweigh the known risks.

The data comes from the US Centers for Disease Control and Prevention, which documented 21 cases of anaphylaxis after administration of a reported 1,893,360 shots from 14 to 23 December.

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“This averages out to a rate of 11.1 anaphylaxis cases per one million doses administered,” senior CDC official Nancy Messonnier told reporters.

By comparison, flu vaccines cause about 1.3 anaphylaxis cases per million doses administered, and so the rate of anaphylaxis for the Pfizer vaccine is roughly ten times greater.

Messonnier added that anaphylaxis cases were still “exceedingly rare” and it remains in people’s best interest to take the vaccine, particularly in the context of the Covid-19 pandemic that is a far greater danger to their health.

“A good value proposition for someone to get vaccinated is their risk from Covid and poor outcomes from Covid is still more than the risk of a severe outcome from the vaccine.”

“Fortunately, we know how to treat anaphylaxis, and we’ve put provisions in place to ensure that at immunization sites, the folks administering the vaccine are ready to treat anaphylaxis,” she said.

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