Vaccination at the Magnolias nursing home, in Loos (North), Monday, December 28, 2020. -

AFP

  • Marseille pharmacologist Joëlle Micallef is tasked by the national drug safety agency with analyzing 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 is for her.

Joëlle Micallef, director of the Marseille-Provence-Corse regional pharmacovigilance center 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 the coronavirus, week after week.

While the vaccination campaign is intensifying, the Marseille pharmacology professor returns for

20 minutes

on her role and the challenge of this mission entrusted to her by the national drug safety agency (ANSM).

What does your role as rapporteur really consist of?

This involves carrying out a weekly analysis of all cases of vaccine adverse reactions 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, in view of the clinical data and information that we collect from around the world.

Does this mean that you expect to face unwanted effects?

Pharmacology is an open system: we don't have a priori one way or the other.

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 the things we are used to doing and which reduce uncertainty.

Why set up such a system?

This is not a new system: in France, we have had this pharmacology system for drugs for 40 years, which allows regular reviews of drugs as soon as they arrive and the serious effects to be traced back 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 feedbacks you have on the effects of the vaccine?

For the moment, we are taking things as they go.

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 meet 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.

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