After nearly 500,000 injections of the first dose of the coronavirus vaccine, the Ministry of Health provided initial information on the adverse effects on Tuesday.
Five people died after being vaccinated against covid-19 and 139 reported serious or unexpected side effects, according to information released by France Info and confirmed by the Directorate General of Health.
An announcement that echoes the 23 deaths recorded in Norway since the start of the vaccination campaign.
The authority specifies that the deceased were over 75 years old and suffered from comorbidities.
The data related to the adverse effects of the Pfizer / BioNTech vaccine are listed by the Regional Pharmacovigilance Centers (CRPV) of Marseille and Bordeaux.
They prepare a weekly report that will be unveiled at the end of the week by the National Medicines Health Agency (ANSM).
Via a press release, the body announced on Tuesday that, in light of the elements, "nothing allows us to conclude that the deaths reported are linked to vaccination".
"No elements to say that these deaths are linked to vaccination"
Mathieu Molimard, head of the medical pharmacology department of the Bordeaux University Hospital on which the CRPV depends, without going into the details of the statistical data under study, is not alarmed by the information unveiled on Tuesday: "We must distinguish the adverse effects and adverse events.
In the second case, it can be a simple concomitance.
500,000 people have been vaccinated, including a large number of nursing home residents and people over 75 years old.
The number of 5 dead does not seem worrying, at first glance.
Norway concluded from the study of its cases (
Editor's note: 23 deaths after injections
) that there were no elements that would justify a modification of the vaccination.
For our part, we study each feedback, without having any information to say that these deaths are linked to vaccination.
"
Among a population of 549,000 people accommodated in nursing homes or long-term care units, 500 die daily in January, according to the 2018 and 2019 average calculated by Epi-Phare, a scientific group created by the ANSM and health insurance.
According to INSEE data, around 18 out of 100,000 people over 75 die every day of the year in France, all audiences included.
If dying cannot therefore be considered as a total anomaly at a very advanced age and with risk factors, it is indeed the individual study of the cases which should make it possible to know whether the vaccine was a trigger or an accelerator.
"I repeat, there is no drug without risk, warns Professor Molimard.
But it's worth it, go for it.
There are deaths that are statistically expected, people who would have died within a week whether or not they were vaccinated.
For other very fragile people, one can wonder if the slight fever given by the vaccine can be the cause of death.
But it does mean that these people would have succumbed to the first cold.
"
"Nothing unexpected in the effects observed"
The 139 cases of serious or unexpected adverse effects are also of concern.
Here again, the pharmacovigilance specialist is reassuring.
The ANSM will have to consolidate the figures, but the doctor evokes "returns of one case in 100,000 of anaphylaxis (
Editor's note: allergic reaction
), requiring an injection of adrenaline, which was expected".
That is a handful of people among the 500,000 who received their first dose, including 110,000 in nursing homes.
The other symptoms identified would be much less serious, according to the scrutineer of the current campaign: “Pharmacovigilance consists of looking for a needle in a haystack, so people should not declare mild adverse effects.
Only those which lead to a consultation with a doctor or hospital should be reported.
In pharmacovigilance, the term serious or unexpected effect may correspond to a simple medical intervention, for example the injection of a corticosteroid.
In the effects observed, there is nothing unexpected: fever, diarrhea, fatigue ... very attenuated symptoms of Covid, which patients would have declared very strongly if they had been affected by the disease.
"
Morning essentials newsletter
A tour of the news to start the day
Subscribe to the newsletterAll newsletters
The Ministry of Health did not indicate within what time frame the five deaths mentioned had occurred, just specifying the location of the reported cases: three in Nancy, one in Montpellier and one in Tours.
