de Oliveira Patricia Mouta Nunes, Hartmann Katharina, Bhamare Chetanraj, Lucchesi Maria Beatriz Bastos
Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil.
Independent Consultant, Zürich, Switzerland.
Vaccine. 2025 Feb 27;48:126727. doi: 10.1016/j.vaccine.2025.126727. Epub 2025 Jan 14.
Developing Countries Vaccine Manufacturers Network (DCVMN) is an alliance of vaccine developers, manufacturers, and marketing authorization holders (MAHs) from low- and middle-income countries (LMICs) that plays a vital role in ensuring equitable, inclusive, accountable, and timely access to affordable, high-quality vaccines in these countries. Besides research and development, this network promotes manufacturing and global supply chains for effective strengthening of regulatory and pharmacovigilance activities. Traditionally, vaccine safety surveillance systems in LMICs rely on spontaneous reporting. However, especially in resource-limited settings, robust passive surveillance is lacking, and active vaccine safety surveillance (AVSS) can complement passive surveillance by actively collecting adverse events at sentinel sites or via formally designed observational (non-interventional) studies. The rapid introduction of novel vaccines during the COVID-19 pandemic with rather limited safety information at deployment accelerated the need for comprehensive AVSS in LMICs to detect potential safety concerns that may not have been identified in pre-licensure trials. In this context, national regulatory agencies (NRAs) and the World Health Organization (WHO) prequalification team requested risk management plans (RMPs) in line with Pharmacovigilance Planning guideline. The submitted RMPs contained the companies' commitments to pharmacovigilance activities encompassing both post-approval routine surveillance (passive) and additional active surveillance activities. These AVSS activities were either committed voluntarily by the manufacturers/MAHs or imposed by the NRA/WHO prequalification in case of important identified or potential risks, or important missing information. Unlike passive surveillance, AVSS relies on various epidemiological methodologies that require resources and expertise. DCVMN initiated a "learn-by-doing" project to support manufacturers/MAHs in performing AVSS. This project focused on improving the understanding of AVSS and its tools, investigated the support needs, opportunities, challenges, and barriers to performing AVSS activities in LMICs, and proposed solutions that could be used to mitigate the main challenges in performing AVSS activities in these countries.
发展中国家疫苗制造商网络（DCVMN）是一个由来自低收入和中等收入国家（LMICs）的疫苗研发者、制造商和营销授权持有人（MAHs）组成的联盟，在确保这些国家公平、包容、可问责且及时地获取价格合理的高质量疫苗方面发挥着至关重要的作用。除了研发之外，该网络还促进制造和全球供应链，以有效加强监管和药物警戒活动。传统上，低收入和中等收入国家的疫苗安全监测系统依赖自发报告。然而，尤其是在资源有限的环境中，缺乏强有力的被动监测，而主动疫苗安全监测（AVSS）可以通过在哨点积极收集不良事件或通过正式设计的观察性（非干预性）研究来补充被动监测。在新冠疫情期间，新型疫苗迅速推出，而在部署时安全信息相当有限，这加速了低收入和中等收入国家全面开展主动疫苗安全监测以发现可能在上市前试验中未被识别的潜在安全问题的需求。在此背景下，国家监管机构（NRAs）和世界卫生组织（WHO）预认证团队要求根据药物警戒规划指南制定风险管理计划（RMPs）。提交的风险管理计划包含了公司对药物警戒活动的承诺，包括批准后的常规监测（被动监测）和额外的主动监测活动。这些主动疫苗安全监测活动要么是制造商/营销授权持有人自愿承诺的，要么是在识别出重要或潜在风险或存在重要缺失信息的情况下由国家监管机构/世界卫生组织预认证强制要求的。与被动监测不同，主动疫苗安全监测依赖各种流行病学方法，这需要资源和专业知识。发展中国家疫苗制造商网络发起了一个“边做边学”项目，以支持制造商/营销授权持有人开展主动疫苗安全监测。该项目侧重于增进对主动疫苗安全监测及其工具的理解，调查在低收入和中等收入国家开展主动疫苗安全监测活动的支持需求、机会、挑战和障碍，并提出可用于缓解这些国家开展主动疫苗安全监测活动主要挑战的解决方案。
