Izurieta Hector S, Zuber Patrick, Bonhoeffer Jan, Chen Robert T, Sankohg Osman, Laserson Kayla F, Sturkenboom Miriam, Loucq Christian, Weibel Daniel, Dodd Caitlin, Black Steve
Food and Drug Administration (FDA), MD, United States.
Vaccine. 2013 Aug 2;31(35):3623-7. doi: 10.1016/j.vaccine.2013.05.027. Epub 2013 May 21.
With the advent of new vaccines targeted to highly endemic diseases in low- and middle-income countries (LMIC) and with the expansion of vaccine manufacturing globally, there is an urgent need to establish an infrastructure to evaluate the benefit-risk profiles of vaccines in LMIC. Fortunately the usual decade(s)-long time gap between introduction of new vaccines in high and low income countries is being significantly reduced or eliminated due to initiatives such as the Global Alliance for Vaccines and Immunizations (GAVI) and the Decade of Vaccines for the implementation of the Global Vaccine Action Plan. While hoping for more rapid disease control, this time shift may potentially add risk, unless appropriate capacity for reliable and timely evaluation of vaccine benefit-risk profiles in some LMIC's are developed with external assistance from regional or global level. An ideal vaccine safety and effectiveness monitoring system should be flexible and sustainable, able to quickly detect possible vaccine-associated events, distinguish them from programmatic errors, reliably and quickly evaluate the suspected event and its association with vaccination and, if associated, determine the benefit-risk of vaccines to inform appropriate action. Based upon the demonstrated feasibility of active surveillance in LMIC as shown by the Burkina Faso assessment of meningococcal A conjugate vaccine or that of rotavirus vaccine in Mexico and Brazil, and upon the proof of concept international GBS study, we suggest a sustainable, flexible, affordable and timely international collaborative vaccine safety monitoring approach for vaccines being newly introduced. While this paper discusses only the vaccine component, the same system could also be eventually used for monitoring drug effectiveness (including the use of substandard drugs) and drug safety.
随着针对低收入和中等收入国家（LMIC）高流行疾病的新型疫苗的出现，以及全球疫苗生产的扩大，迫切需要建立一个基础设施来评估LMIC中疫苗的效益风险概况。幸运的是，由于全球疫苗免疫联盟（GAVI）和实施全球疫苗行动计划的疫苗十年等举措，高收入和低收入国家在引入新疫苗方面通常长达数十年的时间差距正在大幅缩小或消除。在期望更快控制疾病的同时，这种时间转移可能会带来潜在风险，除非在区域或全球层面的外部援助下，在一些LMIC中发展出可靠且及时评估疫苗效益风险概况的适当能力。一个理想的疫苗安全性和有效性监测系统应该是灵活且可持续的，能够快速检测可能与疫苗相关的事件，将它们与计划错误区分开来，可靠且迅速地评估疑似事件及其与疫苗接种的关联，如果有关联，则确定疫苗的效益风险以指导适当行动。基于布基纳法索对A群脑膜炎球菌结合疫苗的评估或墨西哥和巴西对轮状病毒疫苗的评估所显示的在LMIC中进行主动监测的已证实可行性，以及基于国际GBS概念验证研究，我们建议对新引入的疫苗采用一种可持续、灵活、经济且及时的国际协作疫苗安全性监测方法。虽然本文仅讨论疫苗部分，但同一系统最终也可用于监测药物有效性（包括使用不合格药物）和药物安全性。
