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OSLO: Norway said Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement yet by a European health authority as countries assess the real-world side effects of the first injections. to get approval.
Norwegian officials said 23 people had died in the country shortly after receiving their first dose of the vaccine.
Of those deaths, 13 have so far been autopsied, and the results suggest that common side effects may have contributed to serious reactions in frail elderly people, according to the Norwegian Agency for Medicines.
“For those with the most severe frailty, even the relatively mild side effects of the vaccine can have serious consequences,” said the Norwegian Institute of Public Health.
“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 that younger, healthier people should avoid getting vaccinated.
But it’s an early indication of what to watch for when countries start issuing safety monitoring reports on vaccines.
Emer Cooke, the new director of the European Medicines Agency, has said that monitoring the safety of Covid vaccines, especially those that are based on novel technologies like messenger RNA, would be one of the biggest challenges once vaccines are widely implemented.
Until now, allergic reactions have been rare.
In the US, authorities reported 21 cases of severe allergic reactions from December 14 to 23 after the administration of approximately 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.
Although the two Covid-19 vaccines approved so far in Europe were tested in tens of thousands of people, including volunteers in their 80s and 90s, the average trial participant was in their early 50s.
The first people to get vaccinated in many places were older, as countries rush to inoculate nursing home residents at high risk of contracting the virus.
Norway has given at least one dose to some 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly.
In France, a frail patient died in a nursing home two hours after being vaccinated, but authorities said that given the patient’s previous medical history, there is no indication that the death is related 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 did not immediately respond to requests for comment.
The Pfizer-BioNTech vaccine approved late last year has been used more widely, and a similar injection from Moderna Inc approved earlier this month is also being given now.
