In the coming months, his role will be decisive.
At 49, Christelle Ratignier-Carbonneil has just taken the reins of the National Agency for the Safety of Medicines and Health Products (ANSM), in particular in charge of monitoring future vaccines against Covid.
A challenge that this doctor in immuno-hematology intends to take up, well aware that the French expect pledges a few days before the launch of the campaign of the century.
For the first time, she details her strategy.
You take this post in the midst of a global crisis.
Why did you accept it?
CHRISTELLE RATIGNIER-CARBONNEIL.
I know the ANSM house well, its challenges, its responsibilities.
Guiding the 930 employees in the service they provide to patients is even more important in this difficult context of a global pandemic.
It is a challenge that we will take up.
Information for users, monitoring of treatments… our expertise is essential.
And it will continue.
Vaccination is upon us, we will support it.
It could start as early as next week.
Until then, what is your role?
The European Medicines Agency (EMA), which is preparing to deliver its opinion, relies on the expertise of the 27 Member States, including France which has a very strong implication.
Concretely, our agents at the ANSM assess the elements provided by manufacturers, such as those from Pfizer / BioNTech at the moment.
Thousands of pages, curves, statistics, are scrutinized: quality, efficiency, safety, our experienced teams leave nothing to chance.
Each time, they write a sort of mini-thesis.
Despite the urgency, we do not derogate from the irreproachable analysis of the data.
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But once the European green light is given, will France have a say?
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Yes, it will have its role in an essential step called "batch release".
Clearly, before the distribution of vaccines on the territory, official control laboratories, including those of the ANSM, will receive samples to check their content and performance.
And so, if all goes well, "release" them.
This is not superficial, it has happened that products are not delivered for lack of sufficient guarantee.
This final green light for marketing is a key to reassurance for our fellow citizens.
"Vaccines will have to be closely monitored," warn scientists.
It's your mission, how are you going to do it?
We began this work several weeks ago.
Surveillance is essential and will be strengthened.
In France, we have a unique network of 31 pharmacovigilance centers (called CRPVs).
If the French experience any side effect after the injection, they or their doctor should report it.
We will communicate, re-communicate, over-communicate on the site where they can do it (signalement-sante.gouv.fr).
Then, these reports will be investigated to see if they are attributable to the vaccine.
At the same time, specific investigations will be carried out to proactively seek out possible undesirable effects, such as the onset of an autoimmune disease.
For that we need resources.
However, today, there is not in a single reinforcement in these centers ...
We are in the process of discussing with the Ministry of Health.
Resource building is needed and it will take place.
It will not be two / three people in their corner, but as many as the situation requires.
We will be ready as soon as the vaccination begins.
And more studies are planned.
“Specific investigations will be carried out to look for possible undesirable effects”, indicates Christelle Ratignier-Carbonneil./LP/Olivier Arandel
Which ones?
We will rely on pharmaco-epidemiology to monitor all of the people affiliated with Health Insurance and therefore all of the future vaccinated.
After having received the injections, we will be able to see if they have consumed more drugs, consulted their doctor more, carried out more examinations… to have a precise idea of the occurrence of adverse effects in vaccinated people.
We will compare these data with those of populations that have not been and we will measure the differences.
In addition, as vaccination takes place globally - 137,000 Britons have already received these injections - knowledge about effectiveness and safety will continue to improve.
For Pfizer's vaccine, doctors cite many side effects.
And you ?
To date, there are many reactions that are not very pleasant such as pain at the injection site, fever, headaches ... But we also see these side effects with other vaccines, such as influenza. .
They are temporary and above all are not serious.
Today, with two to three months of hindsight, we see no other major consequences.
It is at this stage rather a good sign because of experience, they are rare three to six months after an injection.
Transparency is our priority.
Once the vaccination campaign is launched, a weekly bulletin on adverse reaction reports will be published.
Coronavirus: "We will say everything we know about the vaccine", assures Emmanuel Macron
Why has the Agency never taken a public position on hydroxychloroquine?
Hydroxychloroquine is not a taboo subject.
We treat it exactly the same as all other drugs.
We evaluate based on the data.
However, the information available to us does not allow us to conclude that there is a favorable risk-benefit ratio.
Didier Raoult, his fervent defender, took legal action considering that the ANSM endangered the lives of others by not authorizing this drug.
What do you answer?
That our role is to protect patients.
This is why we have not been able to respond positively to the demand for temporary use of this drug and thus allow it to be widely used, while its benefit-risk ratio is not, to date, favorable.
French morale is low.
Do you rate it?
I confirm it to you.
A latest report (named Epi-flagship) reveals a 5 to 8% increase in the consumption of tranquilizers and sleeping pills during the second confinement.
These figures prove that it is important not to forget all the other patients.
Yes the Covid is a major crisis but the French must continue to take care of themselves, it is essential.