The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-05-01 Epub Date: 2024-02-23 DOI:10.1007/s40264-024-01405-9
Irina Caplanusi, Agnieszka Szmigiel, Menno van der Elst, Marie Louise Schougaard Christiansen, Steffen Thirstrup, Cosimo Zaccaria, Bénédicte Cappelli, Georgy Genov, Sabine Straus
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Abstract

The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the pandemic. An unprecedented number of case reports of suspected adverse reactions after vaccination called for huge efforts for the assessment of this safety information, to ensure that any possible risks were detected and managed as early as possible, while ruling out coincidental but temporally related adverse health outcomes. We describe the role of the European Medicines Agency alongside the EU regulatory network in the safety monitoring of the COVID-19 vaccines, and provide an insight into challenges, particularities and outcomes of the scientific assessment and regulatory decisions in the complex, dynamic international environment of the pandemic. We discuss the flexible procedural tools that were used to ensure an expedited scientific assessment of safety issues, and subsequent updates of the product information (i.e., labelling) when available evidence (e.g., spontaneous reports, findings from observational studies and/or scientific literature) suggested that causal association is at least a reasonable possibility. The safety monitoring was accompanied by enhanced transparency measures, proactive communication, and easy access to information, which played a key role in public reassurance. The pandemic has been a powerful booster for worldwide collaboration, exchange of information and work-sharing. The safety monitoring of COVID-19 vaccines continues, and the lessons learned will be applied in future safety reviews, as well as future health emergencies.

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欧洲药品管理局在 COVID-19 疫苗安全监控中的作用以及在全球范围内提高疫苗安全性的未来方向。
在大流行期间,欧洲联盟(EU)监管网络在 COVID-19 疫苗的安全监控方面走在了前列。疫苗接种后疑似不良反应的病例报告数量之多前所未有,这要求我们付出巨大努力来评估这些安全信息,以确保尽早发现和管理任何可能的风险,同时排除偶然发生但与时间相关的不良健康结果。我们介绍了欧洲药品管理局与欧盟监管网络在 COVID-19 疫苗安全监控中的作用,并深入探讨了在大流行病复杂多变的国际环境中科学评估和监管决策所面临的挑战、特殊性和结果。我们讨论了为确保对安全性问题进行快速科学评估而使用的灵活程序工具,以及在现有证据(如自发报告、观察性研究结果和/或科学文献)表明至少有合理可能性存在因果关系时对产品信息(即标签)进行的后续更新。在进行安全监测的同时,还加强了透明度措施、主动沟通和信息获取的便利性,这在让公众放心方面发挥了关键作用。这次大流行有力地促进了全球合作、信息交流和工作共享。COVID-19 疫苗的安全监测工作仍在继续,吸取的经验教训将应用于未来的安全审查以及未来的卫生突发事件中。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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