Paris (France) (AFP)
Since the start of the Covid vaccination campaigns, cases of people who died after receiving an injection shortly before have been reported in some countries.
Examined closely, these deaths - very few - are not yet attributed to the vaccine.
- Especially elderly and fragile people
Last week, Norway reported 23, then 33, elderly people injected with Pfizer / BioNTech vaccine out of around 20,000 nursing home residents vaccinated at that time, causing concern.
Among them, at least 13 - whose profile was analyzed more closely - were not only "very old" but also "fragile" carriers of "serious diseases", had specified the drug agency.
Without establishing a causal link, the agency hypothesized that side effects of the vaccine such as fever or nausea, not serious for a healthy patient, could "have contributed to a fatal outcome in some fragile patients" .
Outside Norway, these statements had caused a stir and were sometimes used to fuel an anti-vaccine discourse, to the point that the Norwegian authorities then had to insist on the lack of an established link.
In France, on January 22, the Medicines Agency (ANSM) reported 9 deaths of "elderly people residing in Ehpad (accommodation establishments for dependent elderly people) or in old age residences who all presented with chronic diseases and heavy treatments ".
out of 800,000 people vaccinated in total.
Again, "in view of current knowledge on the vaccine Comirnaty (trade name of the vaccine from Pfizer / BioNtech, Editor's note) and the information provided on the cases to date, there is nothing to conclude that the deaths reported are linked to vaccination ", added the ANSM.
Other examples, 13 deaths of elderly subjects have been reported in Sweden and 7 in Iceland, without there either, a causal link has been established to date, according to the health authorities.
Another case in point: in Portugal, the Portuguese media mentioned the case of a caregiver who died two days after being vaccinated in early January.
But the Justice Department said the autopsy had established "no direct link with the Covid-19 vaccine".
On January 18, the French Ministry of Health had mentioned "to date 71 observations of death" at the European level of people who have been vaccinated, without further details.
- No link established but continuous monitoring
For the time being, "no death of an elderly person has been attributed to the Comirnaty vaccine", summed up the European Medicines Agency on January 18, recalling that "as soon as a death or a serious event occurs, the authorities are investigating to see if the vaccine may have played a role.
National and European pharmacovigilance systems - often reinforced with Covid - are used to identify adverse events occurring to a vaccinee, which must be reported by healthcare professionals and manufacturers.
Patients can also make a report.
By themselves, these reports do not mean that there is a cause and effect relationship: they are analyzed in detail by the health authorities to determine if there is a link and, if so, which one.
A complex process.
For the time being, due to their number and the profile of the people, the deaths are not considered to be abnormal in view of the death statistics in the vaccinated population.
In a large number of European countries, it is precisely fragile people (for example residents of nursing homes) who are among the first to be vaccinated.
This is the case in France, Norway, the United Kingdom, Spain ...
"The ramp-up of the campaign increases every day, in this population, the probability of seeing deaths occurring after vaccination against Covid, even in the absence of any effect of the vaccine", recalls in particular the ANSM.
"It is not unexpected that the state of health of some of these (fragile) people worsens because of their age or their pathologies soon after being vaccinated, without the vaccine playing a role", abounds British health products agency.
"When we vaccinate people at high risk of dying, then there will be a number of deaths occurring coincidently soon after vaccination," said Stephen Evans, professor of pharmacoepidemiology, quoted by the organization Science Media Center. .
- Delicate communication: reassurance and transparency
Adding to the complexity of a sensitive subject, all countries do not communicate in the same way: some, such as France or the Nordic countries in particular, choose to report the number of deaths and potential side effects even if no link is established.
Others refrain from giving figures.
The British drug agency for its part indicated that it would communicate regularly "in the future".
The vocabulary is also difficult to handle for the authorities.
If in everyday language a link seems to imply a cause and effect relationship, this is not the case: the "link" may be simply chronological (the death occurred after the vaccine) and not causal (the death is due to the vaccine).
In any case, the health authorities in Europe believe that the deaths do not call into question the safety of the vaccine.
They insist on the soundness of their pharmacovigilance systems and their diligence in investigating any death or serious or unexpected adverse reaction.
They promise to communicate clearly in the event of a worrying signal.
Norway has not changed its vaccination campaign, even though it has renewed its recommendation for a medical evaluation before the administration of the vaccine to a very fragile person or at the end of life, as is done in many country.
At least 60 million doses have been administered in at least 64 countries or territories, according to an AFP count from official sources on January 23 at 11:00 GMT.
burx-jc / BC / fmp / cbn
© 2021 AFP