No links between Pfizer vaccine and elderly deaths; patients already ‘seriously ill’: Norway authorities

OSLO — The Norwegian health authorities have found no evidence of a direct link between a recent spate of deaths among elderly recipients of the Pfizer-BioNTech Covid-19 vaccine.

In an effort to address its citizen’s fears that getting vaccinated might be too risky, the Norwegian Medicines Agency said that those who died were already seriously ill, Bloomberg reported on Monday (Jan 18).

The statement by the health agency comes after 33 people in the country aged 75 and over died following immunisation, in an incident that has made international headlines.

Bloomberg previously reported that the findings have prompted Norway to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill.

Dr Steinar Madsen, the Norwegian Medicines Agency’s medical director, has now told Bloomberg on Monday that “Covid-19 is far more dangerous to most patients than vaccination”.

He added: “We are not alarmed.”

Dr Madsen told Bloomberg that all of the patients who died had serious underlying illnesses.

“We can’t say that people die from the vaccine. We can say that it may be coincidental. It is difficult to prove that it’s the vaccine that is the direct cause,” he said.

Dr Madsen added that it should not be ruled out that it is possible that the side effects of immunisation could “tip the patients into a more serious course of the underlying disease”.

He does not expect a different outcome from Moderna’s vaccine, which was introduced in Norway last Friday.

Similar to Pfizer-BioNTech’s vaccine, it uses messenger RNA technology that teaches the body’s cells to fight off infection.

The Norwegian Medicines Agency told Bloomberg that it had made it clear before the vaccination programme started that “it is expected that deaths will occur in a time-related context with vaccination” for the “oldest and sickest” people receiving inoculation.

Bloomberg reported that Norway had given at least one dose to about 42,000 people, with a focus on those considered to be most at risk if they contract the coronavirus, such as the elderly.

Dr Madsen said that Norway has “more or less” vaccinated all nursing home patients, and the reported fatalities make up “well under one out of 1,000”.

BioNTech said on Monday that Norway has changed its policy on the use of the vaccine to consider excluding the terminally ill, a Reuters report said.

“Norwegian Health Authorities have now changed (their) recommendation in relation to vaccination of the terminally ill (Clinical Frailty Scale 8 or higher),” BioNTech said.

The Clinical Frailty Scale, a widely used system of classification in elder care, defines patients on "scale 8" as approaching end of life and typically unable to “recover even from a minor illness”.

Until last Friday, Bloomberg said Norway had used only the vaccine provided by Pfizer and BioNTech, and the companies are now working with the Nordic country to look into the deaths.

The first Europe-wide safety report on the Pfizer-BioNTech vaccine is due to be published at the end of January, Bloomberg said. AGENCIES