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首页> 美国卫生研究院文献>Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America >Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries 2010–2013
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Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries 2010–2013

机译：2010-2013年在非洲国家引入PsA-TT期间加强疫苗药物警戒活动的经验教训

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>Background. The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns.>Methods. National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects.>Results. Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits.>Conclusions. Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future.
机译：>背景。在非洲脑膜炎带国家推出的A组脑膜炎球菌疫苗PsA-TT代表了首次针对该地区设计的疫苗。仅在第一年，通过大规模疫苗接种运动获得疫苗的人数就比参加受到密切监视的临床试验的受试者高数百倍。因此，在设计和实施这些运动时，将识别罕见但可能严重的疫苗反应的系统的实施放在优先位置。>方法。国家主管部门及其技术合作伙伴建立了有效的疫苗药物警戒系统，包括进行积极的监督项目。>结果。在所有国家中实施国家专家咨询小组以审查所有国家在接种疫苗后的严重不良事件并在3个早期采用者中积极监测相关疾病的状况，并未发现对安全性的特殊关注>结论。从该经验中学到的经验教训将有助于改进在资源匮乏地区未来疫苗引进的准备工作，并充分利用这些努力来发展未来的疫苗安全系统。

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