High levels of coverage with safe and effective immunizations are critical to the successful control and prevention of vaccine-preventable diseases worldwide. In addition to stringent standards to regulate the safety of vaccines, robust postlicensure monitoring systems help ensure that the benefits of vaccines continue to outweigh the risks for the populations who receive them. National Expanded Programmes on Immunization (EPI) are typically responsible for identifying and investigating adverse events following immunization (AEFI), including assessment of causality. National regulatory authorities (NRAs) are mandated to perform postlicensure surveillance of adverse drug reactions, including those associated with receipt of vaccines. This report describes global progress toward meeting World Health Organization (WHO) indicators on minimal country capacity for vaccine safety surveillance and coordination of AEFI reporting between countries' EPI and NRAs. In 2019, among 194 countries, 129 (66.5%) reported having an operational national AEFI causality review committee, compared with 94 (48.5%) in 2010. During 2010-2019, the proportion of countries reporting ≥10 AEFI per 100,000 surviving infants per year (an indicator of country capacity to monitor immunization safety) increased, from 41.2% to 56.2%. In 2019, however, only 46 (23.7%) countries reported AEFI data from both EPI and NRAs. Although global progress has been made toward strengthening systems for vaccine safety monitoring over the past decade, new indicators for monitoring global immunization safety performance are needed to better reflect program functionality. Continued global efforts will be vital to address barriers to routine reporting of AEFI, build national capacity for AEFI investigation and data management, and improve sharing of AEFI data at national, regional, and global levels.

中文翻译：

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免疫安全监控的进展-全球，2010-2019年。

高水平的安全有效疫苗接种对于成功控制和预防全球范围内的疫苗可预防疾病至关重要。除了管理疫苗安全性的严格标准外，强大的许可后监控系统还有助于确保疫苗的收益继续超过接受疫苗的人群的风险。国家免疫接种扩展计划（EPI）通常负责识别和调查免疫接种后的不良事件（AEFI），包括因果关系评估。国家监管机构（NRA）受权对药品不良反应（包括与疫苗接种有关的不良反应）进行许可后监督。本报告描述了在实现世界卫生组织（WHO）关于国家疫苗安全监测的最低能力以及各国的EPI与NRA之间协调AEFI报告的最小能力指标方面的全球进展。2019年，在194个国家中，有129个（66.5％）报告说拥有可运作的国家AEFI因果关系审核委员会，而2010年为94个（48.5％）。2010-2019年，报告每100,000名存活婴儿中AEFI≥10的国家所占的比例年（国家监测免疫安全能力的指标）从41.2％增加到56.2％。然而，在2019年，只有46（23.7％）个国家报告了EPI和NRA的AEFI数据。尽管在过去十年中在加强疫苗安全性监控系统方面已取得全球进步，需要新的指标来监测全球免疫安全绩效，以更好地反映计划的功能。持续的全球努力对于解决AEFI常规报告的障碍，建立国家进行AEFI调查和数据管理的能力以及改善在国家，区域和全球各级AEFI数据的共享至关重要。