TRANSPARENCY: The European Medicines Agency (EMA) must validate possible marketing of Pfizer/BioNTech and Moderna vaccines in Europe
As soon as the vaccination campaign against coronavirus Covid-19 is launched in France, the Medicines Agency (ANSM) will publish a report on the reported adverse reactions each week, the institution announced on Friday, indicating that a “device reinforced ”will be put in place to facilitate their declaration.
“The major challenge is (…) to identify undesirable effects that would not have been observed during clinical trials”, explained Céline Mounier, director of surveillance at ANSM, during an online press briefing. .
Laboratories, healthcare professionals and patients
The European Medicines Agency (EMA) must decide in the coming weeks whether it will grant conditional marketing authorization for two first vaccines against Covid-19, those from Pfizer / BioNTech and Moderna laboratories, an emergency procedure valid for 12 months and which involves close monitoring of the products concerned.
In France, the regional pharmacovigilance centres (CRPV) will be responsible for analyzing the declared side effects and “will take into account not only the cases reported by health professionals and patients but also the cases reported by the laboratories”, detailed Céline Mounier. “We will put these analysis reports online every week,” she added.
An online portal
They will aim to signal the declared events which constitute “potential signals” because they are very serious or unexpected. These same CRPVs will then carry out “expert work” which will make it possible “to confirm or deny the signal and to characterize its level of risk,” she continued. To facilitate the reporting of these cases, the portal for reporting adverse reactions ( signalalement.social-sante.gouv.fr ) will be “modified” to be “accessible as quickly as possible” and immediately collect the relevant information.
If the doctor notices an immediate reaction from the patient after the injection of the vaccine, a click from the Si-Vac platform intended to collect vaccination data will redirect him directly to the site for reporting adverse reactions, without the need to re-enter the information. patient information. In addition, “it is planned a recovery” from vaccinated patients, the terms of which are being discussed with the Ministry of Health, to ask them if they have observed adverse effects after a few days.
