• Clémence Lacroix, Francesco Salvo, Valérie Gras-Champel, Sophie Gautier, Nathalie Massy, Marie-Blanche Valnet-Rabier, Aurélie Grandvuillemin, Céline Mounier, Mehdi Benkebil, Antoine Pariente, Annie-Pierre Jonville-Béra, Joëlle Micallef, and French Network of Pharmacovigilance Centres.
• Centre régional de pharmacovigilance et d'information sur le médicament, service de pharmacologie clinique et pharmacovigilance, Aix Marseille Université, AP-HM, hôpital Sainte-Marguerite, 270, boulevard Sainte-Marguerite 13009, Marseille, France.
• Therapie. 2021 Jul 1; 76 (4): 297-303.

AbstractIn this special issue, we present the main highlights of the first weeks of pharmacovigilance monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented situation in France: the deployment of a vaccination during an epidemic period with the aim of vaccinating the entire population and the intense pharmacovigilance and surveillance of these vaccines still under conditional marketing authorizations. In this unprecedented situation, the cross approach and interaction between the French pharmacovigilance network and French National Agency for the Safety of Medicines and Health Products (ANSM) has been optimized to provide a real-time safety related to COVID-19 vaccines. Every week, pair of regional pharmacovigilance centers gathered safety data from the French pharmacovigilance network, to acutely expertise all the adverse drug reactions (ADRs) reported with each COVID-19 vaccine within a direct circuit with ANSM. Results of this expertise are presented and discussed with ANSM in order to raise safety signals and take appropriate measures if necessary. These reports are then published online. At the 25th of March 2021, more than 9 815 000 doses were injected and 20,265 ADRs were reported, mostly non-serious (76%). Several potential or confirmed signals were raised at the european level for those vaccines and others ADRs are under special attentions. This underlines the adaptiveness of the French pharmacovigilance system to both the identification of new patient profiles experiencing ADRs and the evolution of the vaccine strategy. Such an efficiency is necessary to manage a careful and acute surveillance of these new COVID-19 vaccines for and to face the pandemic at the same time.Copyright © 2021 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

5 keywords...

hide…