Crommelynck Samuel, Grandvuillemin Aurélie, Ferard Claire, Mounier Céline, Gault Nathalie, Pierron Evelyne, Jacquot Baptiste, Vaillant Tiphaine, Chatelet Isabelle Parent du, Jacquet Alexis, Salvo Francesco, Alt Martine, Bagheri Haleh, Micallef Joëlle, Pariente Antoine, Gautier Sophie, Valnet-Rabier Marie-Blanche, Atzenhoffer Marina, Lepelley Marion, Cottin Judith, Lacroix Isabelle, Gras Valérie, Massy Nathalie, Dhanani Alban, Vella Philippe, Shaim Youssef, Baril Laurence, Jonville-Béra Annie-Pierre, Benkebil Mehdi
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 of Burgundy, University Hospital Dijon Bourgogne, 21000 Dijon, France.
Therapie. 2024 Nov 14. doi: 10.1016/j.therap.2024.11.002.
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.
2020年3月，世界卫生组织将严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的出现认定为国际关注的突发公共卫生事件。针对2019冠状病毒病（COVID-19）制定的主要预防措施之一是疫苗。为了监测疫苗从临床开发阶段首次用于人体到向普通人群推广使用的情况及其安全性，法国国家药品和健康产品安全局与30个地区药物警戒中心合作，启用了强化的国家药物警戒系统。在此，我们回顾了法国国家药品和健康产品安全局、30个地区药物警戒中心、疾病相关专家以及欧洲药品管理局的药物警戒和风险评估委员会之间为期两年的合作经验所取得的重大成果。在法国，截至2023年1月，已接种超过1.55亿剂COVID-19疫苗，并分析了19万例免疫接种后的不良事件（25%被归类为严重不良事件）。法国国家药品和健康产品安全局共向欧洲药品管理局的药物警戒和风险评估委员会报告了53个潜在安全信号：13个已得到确认，24个仍在调查中，16个未得到确认。强化的国家药物警戒系统为更好地界定新开发疫苗的安全性作出了积极贡献，法国国家药品和健康产品安全局将继续监测COVID-19疫苗的益处和风险。
