French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge

Autor: Francesco Salvo, Aurélie Grandvuillemin, Annie-Pierre Jonville-Béra, Sophie Gautier, Nathalie Massy, Marie-Blanche Valnet-Rabier, Valérie Gras-Champel, Céline Mounier, Clémence Lacroix, Antoine Pariente, Joëlle Micallef, Mehdi Benkebil
Přispěvatelé: Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], CHU Amiens-Picardie, CHU Lille, CHU Rouen, Normandie Université (NU), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Agence nationale de sécurité du médicament et des produits de santé [Saint-Denis] (ANSM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Otten, Lisa
Rok vydání: 2021
Předmět:
Male
European level
COVID-19 Vaccines
Coronavirus disease 2019 (COVID-19)
Adverse drug reactions
030226 pharmacology & pharmacy
Article
ADR
adverse drug reaction
03 medical and health sciences
Pharmacovigilance
0302 clinical medicine
Pandemic
Medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
Drug reaction
PEG
polyethylene glycol
Entire population
Vaccines
business.industry
SOC
system organ class
SARS-CoV-2
COVID
coronavirus disease
[SCCO.NEUR]Cognitive science/Neuroscience
[SCCO.NEUR] Cognitive science/Neuroscience
Authorization
COVID-19
Middle Aged
medicine.disease
RPVC
Regional Pharmacovigilance Center
Vaccination
EMA
European Medicines Agency
Female
Medical emergency
France
business
ANSM
Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)
Organization
Zdroj: Thérapie
Thérapie, EDP Sciences-Depuis 2016, la revue Thérapie n’est plus publiée par EDP Sciences.> Therapies (Elsevier), 2021, 76 (4), pp.297-303. ⟨10.1016/j.therap.2021.05.003⟩
Therapie
ISSN: 1958-5578
Popis: International audience; In 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.
Databáze: OpenAIRE
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