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A small number of deaths in elderly patients across Europe who had received a COVID-19 vaccine is no cause for concern, says the French Agency for the Safety of Health Products (ANSM).
On January 14, the Norwegian Medicines Agency reported 23 deaths potentially linked to the Pfizer/BioNTec COVID-19 vaccine (Comirnaty), swiftly followed by a further five deaths, alongside 20 serious adverse effects, announced on January 19.
As of January 19, there were “71 observed deaths linked to the Pfizer COVID-19 vaccine” across Europe, “including 16 in the UK and 12 in Germany,” the French Health Minister told Medscape French Edition.
However, the French agency believes that, taking into account the available evidence, there is “nothing to suggest that the reported deaths were linked to the vaccination.”
Together, these cases affect “elderly people, the very old with comorbidities,” the French Minister added. Specifically, 35% of the people who died were over aged 90 years, 46% were older than 80 years, and almost all were over 70 years.
Are these deaths in frail older people directly linked to the vaccine? Could a classic adverse effect of the vaccine, such as fever, destabilize particularly vulnerable people to the point of death?
We talked to Professor Joël Belmin, MD, PhD, head of geriatrics and vaccination coordinator at l’hôpital Charles-Foix, Paris, France, who is calling for 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 dies each year. It’s therefore difficult to directly attribute these deaths to the fact that these people were vaccinated,” he explained.
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 (eg, January).
That’s what we have started to do with our colleagues in Paris and Île-de-France, and is what our colleagues are also doing in Occitanie. Sadly, we won’t have any results before the middle of the year.
If there is a short delay between vaccination and death, does that not suggest causality?
Again, these people are frail. Events could occur contemporaneously with the 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 2 days after vaccination. In fact, this person had a severe urinary infection with an obstruction of the urinary tract…She received antibiotics and is still with us but it could have gone wrong. She could have died within 2 days of vaccination but, on investigation, there was no link with the vaccine.
Could fever that can occur after vaccination cause death in frail older people?
The frailer we are far, the more an event, even a slight one, can disturb a patient’s equilibrium. But a fever of 38ºC, 38.5ºC, 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 adverse effects reported in 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 trial 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 alter 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 registered deaths are in older, frail people living in retirement homes. The expected benefits from vaccination are far greater than the risks.
How is vaccination going in your geriatric service?
We have so far vaccinated 130 older, very frail people and we have not noted any serious adverse effects.
Although the authorities have asked us to vaccinate more people, we are currently facing a sudden slowdown in the delivery of doses, forcing us to cancel vaccination appointments we had given to physicians and healthcare professionals in our hospital, [which is] hard psychologically for our teams.
Personally, I think we should vaccinate more widely. The idea of prioritizing is intelligent, [and while] over 75s are a priority…we must also vaccinate the over 65s, and people with cardiac and respiratory problems, and those with obesity. Also, caregivers aged under 50 years should be vaccinated because if there is a third wave, which seems likely, we will need people to care for the sick.
The problem is that the planning is not keeping up. We have also recently learned that the immunity conferred by the disease in people who survive COVID-19 is far from negligible. I think that people who have survived COVID should not be vaccinated first, particularly in a situation where there are concerns over the supply of doses. They could be vaccinated later. Maybe we need to get that message across.
Do you really see a third wave coming to your hospital?
We see the arrival of the third wave, specifically with the English variant of SARS-CoV-2, which spreads very quickly. It’s a race against time.
We have a cluster of 12 cases of the English variant in our hospital. Several staff members have been affected by it. However, we are trained to pay particular attention to sanitary practices and have all the necessary equipment at our disposal.
This variant seems very contagious. Vaccination is all the more important in this context.
Translated and adapted from Medscape France.