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.
Jazyk:	angličtina
Zdroj:	Therapie [Therapie] 2024 Nov 14. Date of Electronic Publication: 2024 Nov 14.
DOI:	10.1016/j.therap.2024.11.002
Abstrakt:	In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines. (Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)
Databáze:	MEDLINE
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