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Norway recorded a total of 29 deaths among people over the age of 75 who were first vaccinated against Covid-19, raising questions about which groups to target in national inoculation programs.
The latest figure adds six to the number of known deaths in Norway and also decreases the age group considered to be affected from the age of 80.
Until Friday, Pfizer / BioNTech was the only vaccine available in Norway and “all deaths are thus related to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.
“There are 13 deaths that have been assessed and we are aware of another 16 deaths that are currently being assessed,” the agency said. All reported deaths referred to “elderly people with severe underlying disorders,” he said. Most people have experienced the expected side effects of 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 could be too risky for the very elderly and terminally ill, the most cautious statement by a European health authority as countries assess the real-world side effects of early vaccines to gain approval.
The Norwegian Institute of Public Health estimates that “for those with the most severe fragility, even the relatively mild side effects of the vaccine can have serious consequences. For those who have a very short lifespan anyway, the benefit of the vaccine may be marginal or irrelevant. ”
Pfizer and BioNTech are working with the Norwegian regulator to investigate deaths in Norway, Pfizer said in an email. The agency found that “the number of incidents so far is not alarming and is in line with expectations,” Pfizer said.
“We are aware that deaths have been reported in other countries, but we do not yet have full details about this,” the Norwegian drug agency said. “There are also differences between countries in the priority for vaccination, and this could also affect the reporting of side effects, including death.”
“The Norwegian Medicines Agency said before vaccination that when the elderly and the sick are vaccinated, deaths are expected to occur in a time-related context with vaccination. This does not mean that there is a causal link between vaccination and death. Also, in connection with the reported deaths, we transmitted that it is possible that the common and known side effects of the vaccines were a factor that contributed to a serious evolution or to a fatal result “, said the agency.
Norway’s recommendation does not mean that younger and healthier people should avoid vaccination. But it is an early indication of what to look for as countries begin issuing vaccine safety monitoring reports. Emer Cooke, the new head of the European Medicines Agency, said monitoring the safety of Covid vaccines, especially those based on new technologies such as messenger RNA, would be one of the biggest challenges once the launches will take place. be launched widely.