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首页> 外文期刊>Vaccine >A decade of adaptation: Regulatory contributions of the World Health Organization to the Global Action Plan for Influenza Vaccines (2006-2016)
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A decade of adaptation: Regulatory contributions of the World Health Organization to the Global Action Plan for Influenza Vaccines (2006-2016)

机译：适应的十年：世界卫生组织对全球流感疫苗行动计划的监管贡献（2006-2016年）

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The Global Action Plan (GAP) for Influenza Vaccines is a decade-long initiative that brings together a diverse range of stakeholders to work towards reducing anticipated global shortage of influenza vaccines and ensuring more equitable access to vaccines during the next influenza pandemic. Since its inception in 2006, significant progress has been made towards all the main objectives of GAP, namely: (1) an increase in seasonal vaccine use, (2) an increase in vaccine production, and (3) progress in research and development of more effective vaccines. The Technology Transfer Initiative (ITI), conceived and managed by WHO under the GAP, contributed to increasing regional influenza vaccine production capacity. This was achieved by facilitating technology transfer in 14 low- and middle-income countries, through grants to manufacturers to establish or strengthen influenza vaccine production capacity and support to their national regulatory authorities. Five of the countries subsequently licensed locally produced influenza vaccines; two pandemic and three seasonal vaccines received WHO prequalification. The success of GAP can be largely attributed to the regulatory support provided by WHO to both manufacturers and regulators. This support had two components: (1) direct regulatory support to GAP/TTI, and (2) support to GAP-related WHO programmes, such as the Pandemic Influenza Vaccine Deployment Initiative in 2010 and the Pandemic Influenza Preparedness Framework since 2013, especially in non-vaccine-producing countries. Temporary adaptation of the assessment process for influenza vaccines in the WHO Vaccine Prequalification Programme to the A(H1N1) pandemic situation in 2009 was instrumental to the success of the WHO Pandemic Influenza Vaccine Deployment Initiative in its attempt to meet the demand for pandemic vaccines in countries that received donated vaccines. (C) 2016 Published by Elsevier Ltd.
机译：全球流感疫苗行动计划（GAP）是一项为期十年的倡议，该倡议汇集了众多利益相关者，共同致力于减少预计的全球流感疫苗短缺，并确保在下一次流感大流行期间更公平地获得疫苗。自2006年成立以来，朝着GAP的所有主要目标都取得了重大进展，即：（1）季节性疫苗使用量的增加;（2）疫苗产量的增加;（3）疫苗研发的进展更有效的疫苗。世卫组织根据《全球行动计划》设想和管理的技术转让倡议（ITI）为提高区域流感疫苗的生产能力做出了贡献。通过向制造商提供赠款以建立或加强流感疫苗的生产能力并向其国家监管机构提供支持，促进了14个低收入和中等收入国家的技术转让，从而实现了这一目标。随后有五个国家许可在当地生产流感疫苗;两种大流行疫苗和三种季节性疫苗获得了WHO的资格预审。 GAP的成功很大程度上可归因于WHO对制造商和监管机构的监管支持。这种支持包括两个部分：（1）对GAP / TTI的直接监管支持，以及（2）对与GAP相关的WHO计划的支持，例如2010年的大流行性流感疫苗部署计划和2013年以来的大流行性流感防范框架，尤其是在非疫苗生产国。 2009年，世卫组织疫苗资格预审规划中的流感疫苗评估流程暂时适应A（H1N1）大流行情况，这对世卫组织大流行性流感疫苗部署计划的成功开展至关重要，该计划旨在满足各国对大流行性流感疫苗的需求收到捐赠的疫苗。 （C）2016由Elsevier Ltd.出版

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