Norway has registered a total of 29 deaths among people over the age of 75 who've had their first Covid-19 vaccination shot, raising questions over which groups to target in national inoculation programs.
The latest figure adds six to the number of known fatalities in Norway, and also lowers the age group thought to be affected from 80.
Until Friday, Pfizer/BioNTech was the only vaccine available in Norway, and "all deaths are thus linked to this vaccine," the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.
"There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed," the agency said. All the reported deaths related to "elderly people with serious basic disorders," it said. "Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition."
Norway's experience has prompted the country to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement yet from a European health authority as countries assess the real-world side effects of the first shots to gain approval.
The Norwegian Institute of Public Health judges that "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."
Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer said in an e-mailed statement. The agency found that "the number of incidents so far is not alarming, and in line with expectations," Pfizer said.
"We are aware that deaths have also been reported in other countries, but do not have full details of this yet," Norway's medicines agency said. "There are also differences between countries in who is prioritized for vaccination, and this could also affect the reporting of side effects, including death."
"The Norwegian Medicines Agency has communicated, prior to the vaccination, that when vaccinating the oldest and sickest, it is expected that deaths will occur in a time-related context with vaccination. This does not mean that there is a causal link between vaccination and death. We have also, in connection with the reported deaths, conveyed that it is possible that common and known side effects of the vaccines may have been a contributing factor to a serious course or fatal outcome," the agency said.
Norway's recommendation doesn't mean that younger, healthier people should avoid being vaccinated. But it's an early indication of what to watch as countries begin to issue safety monitoring reports on the vaccines. Emer Cooke, the new head of the European Medicines Agency, has said tracking the safety of Covid vaccines, especially those relying on novel technologies such as messenger RNA, would be one of the biggest challenges once shots are rolled out widely.