Norway increasingly concerned about Pfizer COVID-19 vaccine after fatalities rise: Report

Norway has expressed its growing concern regarding the safety of the vaccines produced by American Pfizer Inc. on the senior citizens with serious underlying health conditions after the fatalities rose to nearly 30 among the elderly who received the first dose of the COVID-19 vaccine.

The Scandinavian country as of Friday registered a total of 29 deaths among its citizens over the age of 75 who have had their first shot of Pfizer-BioNTech COVID-19 vaccine, Bloomberg said in a report on Saturday.

It is not yet exactly clear when the deaths occurred but the mortalities are certainly raising questions over which groups to target in national inoculation programs in Norway, which has given at least one dose of the vaccine to some 42,000 people with a focus on those considered most at risk if they contract the virus, including the elderly.

The Norwegian Medicines Agency told Bloomberg that until Friday, the Pfizer-BioNTech COVID-19 vaccine was the only vaccine available in the country, and “all deaths are thus linked to this vaccine.”

“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said, confirming that all the reported deaths related to “elderly people with serious basic disorders.”

It went on to say that most people had experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and deteriorating of their underlying condition.

The report further said that the mortalities in Norway did not mean that younger and healthier people should not receive the vaccine. But it is rather an early indication of what to watch as countries begin to release safety monitoring reports on the COVID-19 vaccines.

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Emer Cooke, new head of the European Medicines Agency, said that tracking the safety of vaccines designed to fight the COVID-19 contagious disease, particularly those developed based on novel technologies such as messenger RNA, would be one of the biggest challenges once shots are rolled out widely.

According to Bloomberg, the two COVID-19 vaccines approved in Europe – namely Moderna and Pfizer-BioNTech vaccines – were tested in tens of thousands of people- including volunteers in their late 80s and 90s – but the average trial participants were in their early 50s.

The sheer number of fatalities prompted Norway to suggest that the COVD-19 vaccines might be too risky for the very old and terminally ill. It is the most cautious statement issued yet from a European health authority.

“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant,” said the Norwegian Institute of Public Health in a statement.

Presently, authorities at Pfizer-BioNTech are working with the Norwegian Medicines Agency to investigate the fatalities in the country.

In an emailed statement, cited by Bloomberg, Pfizer Inc. said that the Norwegian agency had found that “the number of incidents so far is not alarming, and in line with expectations.”

Furthermore, the agency said in a separate statement that it was “aware that deaths have also been reported in other countries, but do not have full details of this yet.”

“There are also differences between countries in who is prioritized for vaccination, and this could also affect the reporting of side effects, including death,” it added.

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