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.
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.
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.
Of 29 cases of potential side effects investigated by Norwegian authorities, almost three-quarters were in people age 80 or older, the regulator said in a Jan. 14 report.
In France, one frail patient died in a care home two hours after being vaccinated, but authorities said 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.