Norway has reported that several elderly people have died shortly after receiving the vaccine for COVID-19. This has sparked some concern regarding the safety of the vaccine, but there’s currently no evidence of a direct link between the deaths and the vaccines. Here’s what you need to know.
As of January 14, there have been 23 reported deaths among severely frail elderly people in Norway within 6 days of receiving their first dose of the BioNTech/Pfizer COVID-19 vaccine, according to the Norwegian Medicines Agency (NOMA).
Health authorities in Norway are closely looking at the deaths, and have so far assessed 13 of the fatalities. Currently, there’s no evidence that the deaths were directly caused by the vaccine. Equally, they can not exclude the possibility that the elderly people had an underlying condition that was aggravated by a common side-effect, such as nausea or fever. However, experts and health authorities are not concerned about the reports in regards to vaccine safety.
"Fatal incidents among these severely frail patients following vaccination do not imply a causal relationship between COVID-19 vaccination and death," Dr Sara Viksmoen Watle, Senior Physician at the Norwegian Institute of Public Health, said in a statement.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly,” Steinar Madsen, medical director of NOMA, told the British Medical Journal. “We are not alarmed or worried about this.”
The Paul Ehrlich Institute in Germany is also reportedly investigating the deaths of 10 people with serious underlying health concerns who died after their COVID-19 vaccination
It’s important to appreciate the wider picture here. It’s clear that elderly people with underlying health conditions face the highest risk of mortality from COVID-19, especially if they live in communal care homes where the disease can be spread easily. According to figures from the US, around 80 percent of deaths are in people 65-years old and older. Even if there is some potential risk from the vaccine among elderly people, it's evident that the risk of dying from COVID-19 is much higher.
Furthermore, it can be expected that extremely elderly people are likely to die in any given period. Therefore, the number of deaths reported after being vaccinated might not necessarily be significantly higher than the number of deaths you’d expect to see in this timeframe.
“We do not yet know, but it would seem that the observed numbers of deaths is not notably above the numbers expected,” commented Professor Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.
Finally, we have to consider the overall number of people that have been vaccinated, and the extremely low number of people who have experienced any nasty side effects. As of January 18, 48,680 people had been vaccinated in Norway, with the vast majority experiencing mild or no side effects.
Pfizer and BioNTech carried out a Phase 3 clinical trial of their COVID-19 vaccine involving over 43,000 participants and found no serious safety concerns. The only notable side-effects, noticed in more than 2 percent of people who received the vaccine, were fatigue (3.8 percent) and headache (2 percent). However, the trials did not include patients with unstable or acute illnesses and included relatively few participants over 85 years of age.
This has led Norway to recommend that severely frail patients or patients with a short remaining life expectancy must be assessed individually to see whether it’s worth them receiving the COVID-19 vaccine. For most people in reasonable health, however, there appears to be no cause for concern.
“Overall, there is no need for anxiety, but complacency is equally mistaken,” assured Professor Evans.