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Norway has expressed growing concern about the safety of the Pfizer Inc. vaccine for older people with serious underlying health problems after raising its estimate of the number of people who died after receiving the vaccines to 29.
The latest figure adds six to the number of known deaths in Norway and broadens the age group believed to be affected to 75 years and up, from 80 years.
While it is unclear exactly when the deaths occurred, Norway has administered at least one dose to some 42,000 people and has targeted those who are considered to be most at risk if they contract the virus, including the elderly.
As of Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are therefore linked to this vaccine,” the Norwegian Medicines Agency said 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,” the agency said. All the reported deaths were related to “older people with serious basic 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.”
Official reports of allergic reactions have been rare as governments rush to roll out vaccines to try to contain the global pandemic. US authorities reported 21 cases of severe allergic reactions from December 14 to 23 after the administration of approximately 1.9 million initial doses of the Pfizer vaccine.
The first European safety report on the Pfizer-BioNTech vaccine will be published at the end of January.
Early indication
The Norwegian experience does not mean that younger and healthier people should avoid being vaccinated. But it’s an early indication of what to watch for when countries start issuing safety monitoring reports on vaccines.
Emer Cooke, the new director of the European Medicines Agency, has said that monitoring the safety of Covid vaccines, especially those that are based on novel technologies like messenger RNA, would be one of the biggest challenges once vaccines are widely implemented.
Although the two Covid-19 vaccines approved so far in Europe were tested in tens of thousands of people, including volunteers in their 80s and 90s, the average trial participant was in their early 50s. The first people to get vaccinated in many places were older than that, as countries rush to inoculate nursing home residents at high risk of contracting the virus.
The findings have led Norway to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement yet by a European health authority.
The Norwegian Institute of Public Health judges 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 of the vaccine may be marginal or irrelevant. “
Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer 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 been reported in other countries as well, but we do not yet have all the details of this,” the Norwegian drug agency said. “There are also differences between countries in who has priority for vaccination, and this could also affect the reporting of side effects, including death.
“The Norwegian Medicines Agency has communicated, prior to vaccination, that by vaccinating the elderly and sickest, 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, “he added.
“Also, in relation to the reported deaths, we convey that it is possible that the common and known side effects of the vaccines may have been a contributing factor to a serious course or fatal outcome,” the agency said. – Bloomberg
