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Norway recorded a total of 29 deaths among people over 75 years of age who received their first Covid-19 vaccine, raising questions about which groups to target in national vaccination programs.
The latter number adds six to the number of fatalities known in Norway and also reduces the supposedly affected age group of 80 years.
Until Friday, Pfizer / BioNTech was the only vaccine available in Norway, and “all deaths are therefore related to this vaccine,” said the Norwegian Medicines Agency in a written response to Bloomberg on Saturday.
“There are 13 deaths that have been evaluated and we are aware of another 16 deaths that are currently being evaluated,” said the agency. All reported deaths were related to “elderly people with severe basic disorders,” the newspaper said. “Most people experienced the side effects expected from the vaccine, such as nausea and vomiting, fever, local reactions at the injection site and worsening of their underlying condition.”
Side effects
Norway’s experience has led the country to suggest 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 be taken approval.
The Norwegian Institute of Public Health assesses that “for those with more severe frailty, even the relatively mild side effects of the vaccine can have serious consequences. For those who have a very short remaining life, the vaccine’s benefit may be marginal or irrelevant. “
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.
“We are aware that deaths have also been reported in other countries, but we do not have complete details about this yet,” said the Norwegian drug agency. “There are also differences between countries in whom vaccination is prioritized, and this can also affect reporting of side effects, including death.”
“The Norwegian Medicines Agency reported, prior to vaccination, that when vaccinating the elderly and the sickest, deaths are expected to occur in a context related to the timing of the vaccination. This does not mean that there is a causal relationship between vaccination and death. We have also communicated, in relation to reported deaths, that it is possible that the common and known side effects of vaccines may have contributed to a serious course or fatal outcome, ”said the agency.
Norway’s recommendation does not mean that younger, healthier people should avoid being vaccinated. 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.