Christelle Ratignier-Carbonneil became in December 2020 the new director of the National Medicines Safety Agency.
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ANSM
How is the surveillance of vaccines against Covid-19 carried out in the short and long term?
Who can report and how?
20 Minutes
interviewed Christelle Ratignier-Carbonneil, the new director of the National Medicines Safety Agency (ANSM) on this hot topic of pharmacovigilance.
With vaccines developed in record time, vigilance and even significant mistrust in France, it is essential to be transparent during this phase of the deployment of the vaccination, she explains.
The agency is at the forefront to alert if ever adverse effects were numerous or atypical.
She went from number 2 to patron of the National Medicines Safety Agency (ANSM) three weeks before the launch of the vaccination against Covid-19 in France.
One more challenge for Christelle Ratignier-Carbonneil, who hopes to make the voice of patients resonate in the agency in charge of monitoring drugs, vaccines and experiments such as therapeutic cannabis.
20 Minutes
was able to meet her.
In France, since the start of vaccination, nine people have died after receiving the Pfizer vaccine.
Should we be worried?
Since the start of vaccination, 144 cases of adverse effects have been reported, including 31 serious effects, including tachycardia.
And nine deaths.
Today, there is no evidence to suggest that there is a link between these deaths and vaccination.
Monitoring continues.
People in nursing homes are obviously elderly, sometimes suffer from several pathologies and follow several drug treatments.
To understand the situation, we looked at the mortality and hospitalizations of residents in nursing homes (between 600,000 and 700,000 people) over the winter months in 2018 and 2019. In France, there are an average of 465 deaths and 1,000 hospitalizations per day in Ehpad during this season.
How exactly is pharmacovigilance concerning vaccines against Covid-19 carried out?
Clinical trials of the Pfizer vaccine have been carried out on 40,000 people, that's a lot.
But that has nothing to do with the current rollout: 40 million doses have been injected [across the world].
Our vaccine monitoring is based on two legs: on the one hand, short-term pharmacovigilance, on the other, monitoring which allows us to look comprehensively and over the long term.
As with all medicines, pharmacovigilance monitors the side effects of vaccines in real life once they are used on a large scale.
They are declared by health professionals, but every French person can also report on the signalement-sante.gouv.fr site and this is essential.
We benefit from a network of 31 regional pharmacoviliance centers (CRPV), unique in Europe.
If an adverse reaction occurs, the reference CRPV investigates whether there is a link with the vaccine.
They also look at the frequency of side effects and whether atypical side effects appear.
All data is collected and analyzed by the ANSM.
A monitoring committee between these CRPVs and the agency meets every week.
An update, which lists the number of side effects and their nature, is published every week on our site.
Second dimension: pharmacoepidemiology, which is based on the national health data system, linked to reimbursements by social security.
Thanks to the EPIPHARE Scientific Interest Group, we are able to monitor people vaccinated over the medium and long term.
And to compare, for example, the hospitalizations of vaccinated and unvaccinated.
To what extent has this surveillance been strengthened compared to a lambda vaccine?
The investigation work of the regional pharmacovigilance centers is carried out for all drugs and vaccines.
We did not create a new structure, but relied on the existing one to strengthen monitoring.
What are the conditions for talking about a "safety signal"?
Occasionally, a CRPV may sound a safety signal if the investigation reveals a possible link between a vaccine and a serious side effect.
In this case, we would take risk reduction measures and communicate in real time.
What are the side effects already known in France?
We see mild, classic effects after a vaccine: fever, headaches and fatigue.
Allergic reactions too, already observed in the United States and the United Kingdom.
They have always been taken care of and without any fatal outcome.
We are constantly adapting: vaccinated people are monitored for fifteen minutes to check that there is no allergic reaction.
The only contraindication concerns people who are allergic to one of the components of the vaccine.
Do you understand the mistrust in France vis-à-vis these vaccines?
It's a real chance to have Covid-19 vaccines available.
But trust depends on being transparent about what we know… and what we don't know.
This distrust encourages us to communicate more and better.
The objective is for everyone to be able to form their opinion on the basis of reliable information.
After nine months of a river trial, the Paris judicial court will deliver its judgment on March 29, 2021 in the Mediator case.
In November 2020, the ANSM was indicted for “injuries and involuntary manslaughter by negligence” in the Dépakine case.
How to explain these dysfunctions?
Both of these cases are devastating for patients.
Patient service has fallen short in the Mediator case.
But we have evolved since.
How to avoid this type of situation?
By opening up and taking into account the words of patients.
We have a close relationship with France Assos Santé, the national union of approved associations of users of the health system.
Since September 2019, we have integrated working groups with healthcare professionals and patients into all our standing scientific committees.
I am very attached to the public hearings broadcast on YouTube, an innovative process that we used for the work on breast implants, on Lutéran / Lutényl.
It's health democracy!
When we take measures, we have to make sure that they are adequate, but also understood.
The world of health products is complex, so you need a clear and understandable discourse.
We are also going to have a new site, redesigned based on the expectations of our users.
It's not just Covid-19 on your agenda, experimentation with therapeutic cannabis should begin in March 2021 ...
This is one of the examples of a concrete response to the needs raised by patients.
In the collective unconscious, there is a lot behind the word cannabis.
But we are in the medical field.
The experiment will be set up before the end of March 2021 for two years and will concern 3,000 patients, suffering from serious pathologies, often at a therapeutic impasse.
We are in the process of setting things up with a call for tenders for suppliers, training for doctors, pharmacists, etc. We are also observing experiences abroad, because I am very keen to look at what is happening elsewhere.
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