https://www.bloomberg.com/news/articles/2021-01-15/norway-warns-of-vaccination-risks-for-sick-patien...
snip:
Norway said 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.
Norwegian officials said 23 people had died in the country a short time after receiving their first dose of the vaccine. Of those deaths, 13 have been autopsied, with the results suggesting that common side effects may have contributed to severe reactions in frail, elderly people, according to the Norwegian Medicines Agency.
“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences,” the Norwegian Institute of Public Health said. “For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”
The recommendation does not mean 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.
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.
Allergic reactions have been uncommon so far. In the U.S., authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the vaccine developed by Pfizer Inc. and BioNTech SE. That’s an incidence of 11.1 cases per million doses, according to the Centers for Disease Control and Prevention.
Though both Covid-19 vaccines approved so far in Europe were tested in tens of thousands of people -- including volunteers in their late 80s and 90s -- the average trial participant was in his or her early 50s. The first people to be immunized in many places have been older than that as countries rush to inoculate nursing-home residents at high risk from the virus.
