Norway has recorded a total of 29 deaths among people over the age of 75 who received the first dose of Pfizer’s COVID-19 vaccine, raising questions about which population groups should be included in vaccination programs.
The latest figure adds six to the number of known deaths in Norway and also lowered the age (80 years) of the group believed to be affected.
As of Friday, the dose of Pfizer and BioNTech was the only vaccine available in Norway, and “all deaths are, therefore, related to this vaccine,” the Norwegian Medicines Agency informed Bloomberg on Saturday.
“There are 13 deaths that have been evaluated and we are aware of another 16 deaths that are currently being studied,” he added. All reported deaths were related to “older people with severe basic disorders,” he noted.
“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,” detailed the agency.
Norway’s experience has led the country to suggest that COVID vaccines may be too risky for the very old and terminally ill, the most cautious statement from a European health authority as countries assess side effects in the real world of the first injections that were approved to fight the pandemic.
The Norwegian Institute of Public Health judged that “for those with the most severe frailty, even the relatively mild side effects of the vaccine can have serious consequences. For those who have a very short remaining life span anyway, the benefit may be marginal or irrelevant. ”
Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, the US drugmaker said in an emailed statement. 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 also been reported in other countries, but we do not yet have all the details of this,” the Norwegian drug agency commented. “There are also differences between countries as to who has priority for vaccination, and this could also affect the reporting of side effects, including death.”
“The Norwegian Medicines Agency has communicated, before vaccination, that when injecting the old and sick, deaths are expected to occur in a context related to the time of inoculation. This does not mean that there is a causal link between vaccination and death. Also, in relation to the deaths reported, we report that it is possible that the common and known side effects of the doses have been a factor that contributed to a serious course or a fatal outcome, “the agency added.
Norway’s recommendation does not mean that younger, healthier people should avoid being inoculated, but it is an early indication of what to watch for when countries begin issuing safety monitoring reports on vaccines.
Emer Cooke, the new director of the European Medicines Agency, has said that monitoring the safety of vaccines against the SARS-CoV-2 virus, especially those that are based on novel technologies such as messenger RNA, would be one of the greater challenges once they are massively implemented.