(Bloomberg) – Norway said that Covid-19 vaccines can be very risky for the very elderly and terminally ill, the most cautious statement by a European health authority as countries assess the real side effects of the first vaccines to get the approval.
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Syringes containing the Pfizer-BioNTech Covid-19 vaccine at University Children’s Clinic in Belgrade, Serbia, on Sunday, January 10, 2021. The Russian Direct Investment Fund (RDIF) signed an agreement with the Serbian government to provide 2 million doses Sputnik V Vacid-19 vaccine, RDIF says in a statement.
Norwegian officials said 23 people died in the country shortly after receiving the first dose of the vaccine. Of those deaths, 13 were 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 those with more 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, the benefit of the vaccine may be marginal or irrelevant.”
The recommendation does not mean that younger, healthier people should avoid vaccination. But it is an early indication of what to watch for when countries start issuing safety monitoring reports on vaccines. Emer Cooke, the new head of the European Medicines Agency, said that tracking the safety of Covid’s vaccines, especially those that rely on new technologies like messenger RNA, would be one of the biggest challenges once vaccines were widely implemented.
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 is in line with expectations,” said Pfizer.
Allergic reactions have been uncommon so far. In the United States, authorities reported 21 cases of severe allergic reactions from December 14 to 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.
Although both Covid-19 vaccines approved so far in Europe have been tested on tens of thousands of people – including volunteers in their 80s and 90s – the average trial participant was in his 50s. The first people to be immunized in many places are older than that, as countries are in a hurry to inoculate nursing home residents at high risk of the virus.
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Norway has given at least one dose to around 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly. The Pfizer-BioNTech vaccine approved late last year has been used more widely, with a similar injection from Moderna Inc. approved earlier this month now also being administered.
Of 29 cases of potential side effects investigated by Norwegian authorities, nearly three-quarters occurred in people aged 80 and over, the regulator said in a January 14 report.
In France, a fragile patient died in a nursing home two hours after being vaccinated, but officials said that due to the patient’s previous medical history, there was no indication that the death was linked to the vaccine. The French pharmaceutical safety agency reported on Thursday four cases of severe allergic reactions and two incidents of irregular heartbeat after vaccination.
The first European-wide safety report on the Pfizer-BioNTech vaccine is likely to be published in late January, the regulator’s drug committee said on Friday. Vaccine manufacturers are required to send data monthly.
In the United Kingdom, which has had more immunizations per capita than anywhere else in Europe, authorities will evaluate safety data and plan to publish details of suspicious reactions “regularly”, said the Medicines and Health Products Regulatory Agency, without giving a date.
(Updates with company comments in the fifth paragraph, regulator in the final paragraphs)
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