OSLO (BLOOMBERG) - 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 so far 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 for as countries begin to issue safety monitoring reports on the vaccines.
Dr Emer Cooke, the new head of the European Medicines Agency, has said tracking the safety of Covid-19 vaccines, especially those relying on novel technologies such as messenger RNA, would be one of the biggest challenges once shots are rolled out widely.
Allergic reactions have been uncommon so far. In the United States, the 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 Centres 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 immunised in many places have been older than that as countries rush to inoculate nursing-home residents at high risk from the virus.
Norway has given at least one dose to about 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly.
In France, one frail patient died in a care home two hours after being vaccinated, but the authorities said that, given the patient's previous medical history ,there is no indication the death was linked to the vaccine.
The French pharmaceutical safety agency on Thursday reported four cases of severe allergic reactions and two incidents of irregular heartbeat after vaccination.
Representatives for Pfizer and BioNTech didn't immediately respond to requests for comment.
The Pfizer-BioNTech vaccine approved late last year has been used most broadly, with a similar shot from Moderna Inc approved earlier this month also now being administered.