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Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines

机译：国际合作流行病学监测新型高优先级疫苗安全性和有效性的路线图

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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
机译：随着针对低收入和中等收入国家（LMIC）的高度流行性疾病的新疫苗的问世，以及全球疫苗生产的扩展，迫切需要建立一个基础设施来评估该国疫苗的利益风险状况LMIC。幸运的是，由于全球疫苗和免疫联盟（GAVI）和全球疫苗十年计划等倡议，高收入和低收入国家在引入新疫苗之间通常存在的十年间的时间间隔已被大大减少或消除。全球疫苗行动计划的实施。在希望更快地控制疾病的同时，这种时间转移可能会增加风险，除非在区域或全球范围内的外部援助下发展出了一些可靠且及时地评估某些中低收入国家的疫苗受益风险状况的适当能力。理想的疫苗安全性和有效性监测系统应灵活且可持续，能够快速检测可能的疫苗相关事件，将其与程序错误区分开来，可靠，快速地评估可疑事件及其与疫苗接种的关联，并确定其益处。 -接种疫苗的风险以通知采取适当行动。根据布基纳法索评估的脑膜炎球菌A结合疫苗或轮状病毒疫苗在墨西哥和巴西的评估，证明在LMIC中进行主动监测的可行性，并根据国际GBS研究的概念证明，我们建议可持续，灵活，价格合理新推出了针对疫苗的及时国际协作疫苗安全性监测方法。尽管本文仅讨论疫苗成分，但最终还是可以使用同一系统来监视药物有效性（包括使用不合格药物）和药物安全性

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