Independent Consultant, Kusnacht, Switzerland.
DCVMN International, Route de Crassier 7, 1262 Nyon, Switzerland.
Vaccine. 2020 Jul 22;38(34):5490-5497. doi: 10.1016/j.vaccine.2020.06.016. Epub 2020 Jun 24.
Developing Countries' Vaccine Manufacturers Network was tasked with the strategic goal of seeking solutions, jointly with manufacturers, for enabling the stable, sustainable supply of quality vaccines to developing countries to increase global immunization. As vaccines are given to millions of healthy people, including children, to prevent life-threatening diseases, vaccines must meet high safety standards. Vaccine safety monitoring is of paramount importance to maintain trust in vaccination programs globally. Once a vaccine is licensed and recommended for use, its safety and effectiveness must be monitored during its whole lifecycle, as the safety profile and protective effectiveness may change over time. A well-established safety governance model across the organization with underlying processes for data collection, signal and risk management and communication is essential. A "fit for purpose" pharmacovigilance system may vary as it depends on several factors. However, all vaccine manufacturers strive to achieve a pharmacovigilance system satisfying Good Pharmacovigilance Practices, in compliance with national, international and supranational requirements, as applicable. A landscape analysis, using a questionnaire covering nine pharmacovigilance key areas related to an effective system, was conducted to understand the existing pharmacovigilance structures, practices and expertise of vaccine manufacturers from emerging countries, on an institutional level. 34 of the 43 contacted manufacturers participated voluntarily. The survey results show that all respondents have established vaccine safety capacity, mainly in collecting and handling adverse events following immunization and implementing standardized processes; the survey also shows differences in the maturity of the manufacturers' pharmacovigilance system, Quality Management System, signal and risk management, and safety governance. The analysis provides a tool for manufacturers to gain a "bird's-eye" view of the structure of pharmacovigilance key areas and the operational dimensions covered by each area, to benchmarking against international expectations, serving as a basis to further strengthen pharmacovigilance systems, to support accelerated global vaccine supply.
发展中国家疫苗制造商网络的战略目标是与制造商共同寻求解决方案，以使发展中国家能够稳定、持续地获得高质量疫苗，从而增加全球免疫接种率。由于疫苗是给包括儿童在内的数百万健康人群接种，以预防危及生命的疾病，因此必须达到很高的安全标准。疫苗安全监测对于维护全球疫苗接种计划的信任至关重要。一旦疫苗获得许可并建议使用，就必须在其整个生命周期内监测其安全性和有效性，因为安全性概况和保护效力可能会随时间而变化。在整个组织内建立完善的安全治理模式，包括数据收集、信号和风险管理以及沟通的基础流程，是必不可少的。一个“适合目的”的药物警戒系统可能因各种因素而异。然而，所有疫苗制造商都努力实现符合良好药物警戒实践的药物警戒系统，以符合国家、国际和超国家的适用要求。本研究采用涵盖九个与有效系统相关的药物警戒关键领域的问卷，对新兴国家疫苗制造商的机构层面现有的药物警戒结构、实践和专业知识进行了景观分析。在联系的 43 家制造商中，有 34 家自愿参与了调查。调查结果表明，所有受访者都已建立了疫苗安全能力，主要集中在收集和处理疫苗接种后不良反应以及实施标准化流程方面；调查还显示了制造商药物警戒系统、质量管理体系、信号和风险管理以及安全治理成熟度的差异。该分析为制造商提供了一个工具，可以从整体上了解药物警戒关键领域的结构和每个领域涵盖的操作维度，以便与国际预期进行基准比较，为进一步加强药物警戒系统提供依据，从而支持加速全球疫苗供应。
