A calendar so fast that it impresses as much as it questions.
A population drowned under the figures and contradictory opinions of doctors.
A few days before Christmas, the anti-Covid vaccination is in everyone's mind.
After Great Britain and Canada, it took this Friday a new regulatory step in the United States, where the green light for the vaccine from Pfizer-BioNTech is only a matter of days.
In Europe, the decision should be made before December 29.
And "at the latest" January 12 for the injection of Moderna.
“It is legitimate to ask questions.
Reading the studies published these days shows that there are no major concerns to be had, but that there are still several unknowns and that the vaccines will have to be monitored, ”summarizes virologist Morgane Bomsel.
Monitor, the word is out.
And according to the National Medicines Safety Agency (ANSM), the drug gendarme in France, which has the prerogative, this surveillance will be "reinforced" from the first bites in early 2021. "In this exceptional situation, the watchword , it is transparency ”, promised Friday the doctor Christelle Ratignier-Carbonneil, about to take the head of the ANSM while she gave details on its strategy.
31 support centers
Nestled in hospitals, 31 centers (officially called CRPV) provide pharmacovigilance in France.
The pharmaco-what?
Little known to the population, it is the heart of the surveillance of health products in France, based on reports from health professionals or the patients themselves.
“It is for example the regional pharmacovigilance centers which have brought up the heart rhythm disturbances caused by hydroxychloroquine
(Editor's note: the treatment advocated by Professor Didier Raoult)
and launched the alert in France and in Europe.
Our role is essential, ”explains the director of one of them.
"They will collect in real time the potential unexpected side effects linked to Covid-19 vaccines, or so-called significant cases, a heart problem, for example", explains Céline Mounier, director of surveillance at ANSM.
Every week, it's new, a report will be made public.
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A huge task, added to the others, but how?
"Additional human resources are planned", assures the ANSM, without further details.
And for good reason, in the field, we are still waiting!
“No, the reinforcements are not yet there despite the volume of reports that we expect to deal with, blows an official.
It will have to be unlocked ... quickly.
"
VIDEO. Coronavirus: "We will say everything we know about the vaccine" assures Emmanuel Macron
(Well) explain how to report
In theory, healthcare professionals have an obligation to report side effects in their patients.
In practice, not all do.
Good to know: since March 2017, anyone can do so directly on the signalement-sante.gouv.fr site.
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This portal will be improved and strengthened "in order to collect relevant data related to the Covid vaccination".
"We are going to make it more accessible and ensure communication to the general public to remind them of its existence and how to properly declare these effects, if there are any," continues Céline Mounier.
New technologies in reinforcement
Not easy to detect all the signals… But the ANSM is counting on the help of artificial intelligence to better identify and categorize them.
At the same time, other studies will be launched, particularly epidemiological, with the Health Insurance, to measure the risks of serious effects at the population level.
There are those already known (but very rare), likely to occur after any vaccination, such as neurological damage such as Guillain-Barré syndrome which can lead to paralysis.
And others - possible - that must be watched.
"One which is hypothesized but which has never been observed is the exacerbation of the Covid-19 disease by the vaccination itself", explains Rosemary Dray-Spira, the deputy director of the scientific interest group Epi -Headlight.
Pfizer vaccines, really undesirable effects?
Designed using a recent technology known as messenger RNA, Pfizer's vaccine has drawn the wrath of some doctors.
In our columns, professor of infectious disease Eric Caumes even estimated that he had "never seen such a high frequency of adverse effects for a vaccine.
"
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“The frequency may be a little higher than usual (redness at the injection site, a little pain), but the proportion of severe cases is extremely low.
Today we have no warning signal, ”reassures Isabelle Parent, head of the ANSM vaccine unit, who also recalls that the trials involve a large number of participants, 40,000 for Pfizer (and 30,000 for Moderna).
A study published in the New England Journal of Medicine confirms its effectiveness and safety.
“It's reassuring,” points out Morgane Bomsel. But the virologist from Cochin hospital in Paris raised two hares: “We have no hindsight beyond two months. And no data for asymptomatic people. However, this determines our strategy in the face of Covid: is it just a matter of protecting the elderly from a serious form or of blocking the pandemic in the general population? We still have to learn! "