- Last week, Norway reported 23 deaths among elderly patients who had received the first dose of the Pfizer COVID-19 vaccine.
- Norwegian authorities have so far assessed 13 of the deaths and found no link between the deaths and the vaccine.
- Although Pfizer’s phase 3 trials reported no serious adverse reactions, it included very few participants over 85 years of age.
On January 14th, Norway reported 23 deaths among elderly patients following vaccination with the Pfizer vaccine. The deaths occurred within 6 days of the patients receiving their first dose. So far, the Norwegian Medicines Agency (NOMA) and the National Institute of Public Health have analyzed 13 of the deaths.
Norway began its vaccination drive in December of last year. As of 18th January, the Scandinavian country had vaccinated a total of 48, 680 people. Similar to other countries, the first few doses went to those belonging to high-risk groups. This included healthcare workers, residents of nursing homes, and the elderly.
When we vaccinate the eldest and sickest who often have several underlying conditions we expect high mortality in this population. Hence, we also expect deaths following vaccination. We do not yet know if these deaths are due to the vaccine or other causes, but we cannot exclude that common side effects may have led to a more severe course for some patients.
Dr. Sara Viksmoen Watle, Senior Physician at the NIPH
Deaths in Norway Raise Concerns About Vaccine Safety
Currently, two COVID-19 vaccines have received approval for use in Norway; Pfizer/BioNTech’s and Moderna’s. Since Moderna received approval earlier this month, authorities believe Pfizer’s vaccine is responsible for the recent deaths.
Pfizer has now released a statement; citing the incidents as ‘in line with expectations.’ According to the statement, most of the people receiving the vaccine are either the elderly suffering from underlying medical conditions or the terminally ill. Therefore, in such populations, mild adverse reactions can often have fatal outcomes.
Based on these reports we cannot rule out that common adverse reactions, such as fever and nausea, may contribute to a more serious course and fatal outcome in some frail patients with severe underlying diseases.”
Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.
However, it is important to note that Pfizer’s phase 3 trials included very few participants over the age of 85. Furthermore, it did not include patients with underlying medical conditions.
No Link Between Vaccine and Deaths
The Norwegian authorities have so far assessed 13 of the reported deaths. They have not identified any direct link between the deaths and vaccines. Moreover, they do not believe the reported deaths reflect on the vaccine’s safety.
It is important to remember that about 45 people die every day in nursing homes in Norway, so it is not a given that this represents any excess mortality or that there is a causal connection
Camilla Stoltenberg, director of the Norwegian Institute of Public Health (FHI)
According to NOMA, around 400 people die in nursing homes every week. Therefore, such incidents are expected. Consequently, researchers are advising doctors to assess individuals before administering the vaccine. In frail or terminally ill patients it should be assessed whether the benefits of vaccination outweigh the risk of potential adverse effects.
Reference:
Torjesen Ingrid. Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination BMJ 2021; 372 :n149. https://doi.org/10.1136/bmj.n149
