Jan. 22, 2021 -- A small number of deaths occurring in elderly patients who had received a COVID-19 vaccine across Europe is not cause for concern, says the French Agency for the Safety of Health Products (ANSM).

As of January 19, there were “71 observed deaths linked to the Pfizer COVID-19 vaccine,” across Europe, “including cases in the UK, Germany, 16 in the UK and 12 in Germany,” said French Health Minister Olivier Véran. The Norwegian Medicines Agency also reported 28 deaths.

The French agency says there is “nothing to suggest that the reported deaths were linked to the vaccination.”

These cases affect “elderly people, the very old with comorbidities,” said Véran. Specifically, 35% of the people who died were over 90 years old, 46% were older than 80, and almost all were over 70 years old.

Medscape talked to Professor Joël Belmin, head of geriatrics, and vaccination coordinator, at l’hôpital Charles-Foix, Paris. Belmin urges people to not jump to conclusions, as vaccination can save many lives.

"In older people, due to their great frailty, a significant amount of spontaneous mortality is expected. In a retirement home, one in five people die each year. It’s therefore difficult to directly attribute these deaths to the fact that these people were vaccinated,” he said.

How could we confirm or deny the link between these deaths and vaccination against COVID-19?

There are ways of knowing if there is excess mortality linked to the vaccine. For example, we can compare the number of deaths in retirement homes and long-term care … between people vaccinated and those unvaccinated, or from one year to the next over the same period.

That’s what we have started to do …. We won’t have any results before the middle of the year.

If there is a short delay between the vaccination and death, does that not suggest causality?

Again, these people are frail. Events could occur at the same time as vaccination but not be specifically due to the vaccine.

For example, in our hospital we have vaccinated people in long-term care and we had a person with an unusual fever two days after the vaccination. In fact, this person had a severe urinary infection with an obstruction of the urinary tract.

Could the fever that can occur after vaccination cause death in frail older people?

The more frail we are far, the more an event, even a slight one, can disturb a patient’s equilibrium. But a fever of 100.4 F, 101.3 F over several hours following vaccination is not life-threatening, even in someone frail. One would have to think of very severe pain, or a very high fever leading to dehydration.

So far, we haven’t had any details on the conditions surrounding these deaths.

Could other side effects reported in the clinical trials explain these deaths?

Overall, there isn’t a particular concern that we have seen in the clinical trials but it is also true that the population does not include such frail people. Strictly speaking, we cannot extrapolate these results to populations who were not represented in the trials.

Will the reported deaths change your approach to vaccinating older patients?

No. Given the seriousness of COVID-19 in this population, this information will not upset our practice. These 71 deaths in Europe so far must be compared with the few million who have been vaccinated.

In each country, 40%–60% of all the registered deaths are in older, frail people living in retirement homes. The expected benefits from vaccination are far greater than the risks.