Norway has said Covid-19 vaccines could be too risky for the very old and terminally ill, the most cautious statement to date from a European health authority as countries assess the real side effects of early vaccines for 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, with the results suggesting that common side effects may have contributed to serious reactions in frail elderly people, according to the Norwegian Medicines Agency.
“For the most frail people, even relatively mild side effects can have serious consequences,” said the Norwegian Institute of Public Health. “For those who have a very short remaining lifespan anyway, the benefits of the vaccine may be marginal or irrelevant.”
The recommendation does not mean that younger, healthier people should avoid being vaccinated. But it’s an early indication of what to watch out for as countries begin to publish vaccine safety surveillance reports. Emer Cooke, the new head of the European Medicines Agency,saidMonitoring the safety of Covid vaccines, especially those that rely on new technologies such as messenger RNA, would be one of the biggest challenges once vaccines are widely deployed.
Allergic reactions have been rare so far. In the United States, authorities reported 21 cases of severe allergic reactions from December 14 to 23 after receiving approximately 1.9 million initial doses of the vaccine developed by Pfizer Inc. and BioNTech SE. This is an incidence of 11.1 cases per million doses,according toat the Centers for Disease Control and Prevention.
Although the two Covid-19 vaccines approved so far in Europe have been tested in tens of thousands of people – including volunteers in the late 1980s and 1990s – the average trial participant was in the early years of the fifties. The first people to be vaccinated in many places have been older than that as countries rush to vaccinate residents of nursing homes at high risk of the virus.
Norway has administered at least one dose to around 33,000 people, focusing on those considered most at risk if they contract the virus, including the elderly.
In France, a fragile patient died in a care home two hours after being vaccinated, but authorities said given the patient’s medical history, there was no indication the death was vaccine-related. 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 most widely, with a similar vaccine from Moderna Inc. approved earlier this month also now being administered.
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