The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report.

Autor: Crommelynck S; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France. Electronic address: samuel.crommelynck@ansm.sante.fr., Grandvuillemin A; Regional Pharmacovigilance Centre of Burgundy, University Hospital Dijon Bourgogne, 21000 Dijon, France., Ferard C; French National Agency for Medicines and Health Products Safety, ANSM, Direction for Surveillance, 93200 Saint-Denis, France., Mounier C; French National Agency for Medicines and Health Products Safety, ANSM, Direction for Surveillance, 93200 Saint-Denis, France., Gault N; French National Agency for Medicines and Health Products Safety, ANSM, General Direction for Operations, PRAC representative, 93200 Saint-Denis, France., Pierron E; French National Agency for Medicines and Health Products Safety, ANSM, Direction for Surveillance, 93200 Saint-Denis, France., Jacquot B; French National Agency for Medicines and Health Products Safety, ANSM, Direction for Surveillance, 93200 Saint-Denis, France., Vaillant T; French National Agency for Medicines and Health Products Safety, ANSM, General Direction for Operations, PRAC representative, 93200 Saint-Denis, France., Chatelet IPD; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; Santé Publique France, Infectious Diseases, 94410 Saint-Maurice, France., Jacquet A; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France., Salvo F; Regional Pharmacovigilance Centre of Bordeaux, DROM, University Hospital of Bordeaux, 33000 Bordeaux, France; UMR 1219 Pharmacoepidemiology Team, Bordeaux Population Health Research Centre, Inserm, University of Bordeaux, 33000 Bordeaux, France., Alt M; Regional Pharmacovigilance Centre, University Hospital of Strasbourg, 67091 Strasbourg, France., Bagheri H; Department of Medical and ClinicalPharmacology, Centre of Pharmacovigilance, Pharmacoepidemiology and Informations on Medications, Inserm UMR 1027, University Hospital and Faculty of Medicine, 31000 Toulouse, France., Micallef J; Department of Clinical Pharmacology and Pharmacovigilance, Regional Pharmacovigilance Centre of Marseille, AP-HM, 13000 Marseille, France., Pariente A; Regional Pharmacovigilance Centre of Bordeaux, DROM, University Hospital of Bordeaux, 33000 Bordeaux, France., Gautier S; Departement of Clinical Pharmacology, University Hospital, Regional Pharmacovigilance Centre of Lille, 59000 Lille, France., Valnet-Rabier MB; Regional Pharmacovigilance Centre of Franche-Comté, University Hospital of Besançon, 25000 Besançon, France., Atzenhoffer M; University Hospital Department of Pharmacotoxicology, Regional Pharmacovigilance Centre, Civil Hospices of Lyon (HCL), 69003 Lyon, France., Lepelley M; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; Regional Pharmacovigilance Centre, University Hospital of Grenoble-Alpes, 38000 Grenoble, France., Cottin J; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; University Hospital Department of Pharmacotoxicology, Regional Pharmacovigilance Centre, Civil Hospices of Lyon (HCL), 69003 Lyon, France., Lacroix I; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; Department of Medical and ClinicalPharmacology, Centre of Pharmacovigilance, Pharmacoepidemiology and Informations on Medications, Inserm UMR 1027, University Hospital and Faculty of Medicine, 31000 Toulouse, France., Gras V; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; Pharmacovigilance Centre, Department of Clinical Pharmacology, Amiens Picardie University Medical Centre, 80054 Amiens, France., Massy N; Regional Pharmacovigilance Centre, Clinical Pharmacology Department, Rouen University Hospital, 76031 Rouen, France., Dhanani A; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France., Vella P; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France., Shaim Y; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France., Baril L; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; Santé Publique France, Infectious Diseases, 94410 Saint-Maurice, France., Jonville-Béra AP; French National Agency for Medicines and Health Products (ANSM), Direction for Medical Drugs Department, Department of Infections and Emerging Disease, 93200 Saint-Denis, France; Departement of Pharmacosurveillance, University Hospital, Regional Pharmacovigilance Centre Val-de-Loire, 37000 Tours, France., Benkebil M; French National Agency for Medicines and Health Products Safety, ANSM, Direction for Surveillance, 93200 Saint-Denis, France.

Publikováno v: Therapie [Therapie] 2024 Nov 14. Date of Electronic Publication: 2024 Nov 14.