Norway raises COVID-19 vaccine concerns for elderly after 29 deaths
Norway has expressed concern over the safety of the COVID-19 vaccine developed by Pfizer and BioNTech among older populations as 29 people died after receiving the shot. The deceased include people over the age of 75 with serious underlying health conditions who had received the Pfizer-BioNTech vaccine. Roughly 42,000 people have received at least one shot of the two-dose vaccine in Norway.
As of Friday, Pfizer-BioNTech's vaccine (named tozinameran) was the only vaccine to be approved in Norway. "All deaths are thus linked to this vaccine," the Norwegian Medicines Agency (NMA) said in a statement to Bloomberg on Saturday. Tozinameran is the first COVID-19 vaccine to be approved for use in the West and also the first-ever messenger RNA (mRNA) vaccine available for widespread use.
On Saturday, Norway confirmed the 29 deaths after receiving inoculations, adding six new deaths in the past day. The latest figure also lowered the age group of those thought to be affected by the vaccine from 80 previously to 75. "There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed," the NMA said.
All the reported deaths are related to "elderly people with serious basic disorders," the NMA 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."
Although Tozinameran was widely tested in Europe, including volunteers in their late 80s and 90s, the average trial participant was in their early 50s. The people who are now being prioritized for vaccinations are well above that age as countries are rushing to vaccinate nursing-home residents first. The elderly and those with underlying health conditions remain at high risk from the coronavirus.
The Norwegian Institute of Public Health has said that "for those with the most severe frailty, even relatively mild vaccine side-effects 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," it said. However, the recent alarm does not mean that younger, healthier people should avoid being vaccinated.
Both Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer said in a statement to Bloomberg. Pfizer said the agency found that "the number of incidents so far is not alarming, and in line with expectations." The NMA said it is aware of deaths in other countries, but it does not have the full details yet.
The NMA said it has communicated that deaths are expected to occur in a "time-related context with vaccination" among the oldest and sickest. "This does not mean that there is a causal link between vaccination and death," it said. The agency further highlighted the possibility that common and known side-effects may be contributing to a serious course or fatal outcome.