Vaccination at the Magnolias nursing home, in Loos (North), Monday 20 December 2020. – AFP
Marseille pharmacologist Joëlle Micallef is responsible by the national security agency for medicine to analyze the adverse effects of the coronavirus vaccine.
A mission that she intends to carry out in full transparency and independence to reassure the French on this subject.
If there is the slightest glitch, it’s for her. Joëlle Micallef, Director of the Regional Pharmacovigilance Center Marseille – Provence-Corse within the AP-HM was tasked, with a colleague from Bordeaux, to identify and analyze all the serious adverse effects of the Pzifer-Biotech vaccine against coronavirus , week after week. While the
vaccination campaign intensifies, the Marseille pharmacology professor is back for 20 Minutes on its role and the challenge of this mission entrusted to it by the national drug safety agency (ANSM).
In What exactly does your role as rapporteur consist of?
This involves carrying out an analysis every week of all the cases of adverse effects of the vaccine that have occurred in France. We receive reports every day, processed and documented in advance by the regional pharmacology centers. I, as a national expert, summarize all the cases that I will have every day. Our job is not so much to take inventory, like an accountant. Above all, we have a medical role: as a doctor, faced with a symptom, questions his patient, we will investigate from the elements transmitted. Then, we send back these analyzes every week during a meeting with the drug agency to have a scientific discussion on these questions, with regard to the clinical data and information that we collect around the world.
Does this mean that you expect to face unwanted effects?
Pharmacology is an open system: we do not have a priori in one sense or another. There may be things that will be fed back to us. It is obvious that the more people we have vaccinated, the more we risk having an increase, by a simple chronological effect. But we are going to carry out investigative work, as a pharmacologist, to say whether this or that effect is indeed linked to the vaccine. You have to be very careful. Diseases can be wrongly attributed to the vaccine as life goes on, and other diseases can be contracted under other circumstances. These are things that we are used to doing and which reduce uncertainty.
Why set up such a system?
It’s not not a new system: in France, this makes 28 years that we have this pharmacology system for drugs, which allows regular reviews of drugs as soon as they arrive and report serious effects to the European Medicines Agency. There, for the vaccine, it was decided to set up a reinforced device. The French need transparency, it is a legitimate request on this issue. What they want is to have information validated by independent experts, in a world where there is fake news. We must respond to this expectation in the best possible way by dispelling misunderstandings and restoring serenity in all this, based on facts. However, when you are a pharmacologist, you work in complete independence, in a public structure that has no direct or remote link with the laboratories. We’ve been right in our boots for years.
What are the first feedback you have on the effects of the vaccine?
For now, we are receiving things at flow of water. The campaign has intensified. It is therefore necessary to see if this brings up serious or unexpected new effects. As I speak to you, we have not received anything in this direction. We will write a summary for this week. We are meeting tomorrow before the publication of a press release at the end of the week, and the bulletin will be available on the website of the drug agency.