Data and product needs for influenza immunization programs in low and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation influenza vaccines
Data and product needs for influenza immunization programs in low and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation influenza vaccines
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DOI：
10.1016/j.vaccine.2017.08.088
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发表时间：
2017-10-13
期刊：
影响因子：
5.5
通讯作者：
Ortiz, Justin R.
中科院分区：
文献类型：
--
作者：
Neuzil, Kathleen M.;Bresee, Joseph S.;Ortiz, Justin R.
2017年，世卫组织召集了一个由全球专家组成的工作组，制定下一代流感疫苗的首选产品特性（PPC）。 PPC 旨在鼓励疫苗开发创新。它们描述了世卫组织对疫苗参数的偏好，特别是其适应症、目标群体、实施策略以及评估安全性和有效性所需的临床数据。 PPC 是根据世界卫生组织鼓励疫苗开发的重点疾病领域未满足的全球公共卫生需求而制定的。这些偏好反映了世卫组织促进开发对中低收入国家具有较高公共卫生影响和适用性的疫苗的使命。目标受众是打算在这些环境中开发或实现特定流感疫苗产品广泛采用的所有实体。工作组确定现有的流感疫苗不太适合中低收入国家使用。尽管许多发达国家的制造商和研究资助者优先考虑将流感疫苗产品用于成人和老年人，但大多数中低收入国家没有足够强大的卫生系统来向这些群体提供疫苗。中低收入国家的政策制定者预计将更加重视用于预防严重疾病的疫苗，但流感疫苗的临床开发重点是证明可以预防任何流感疾病。许多流感疫苗产品不符合世界卫生组织关于疫苗规划适用性的标准，这在资源匮乏的环境中使用疫苗时带来了挑战。最后，考虑到疫苗许可期限、温带国家市场的任意有效期以及流感季节性较长的国家需要全年免疫，当前的疫苗无法与中低收入国家的常规免疫计划很好地结合。虽然所有感兴趣的各方应参阅完整的 PPC 文件以了解详细信息，但在本文中，我们强调了新型流感疫苗的数据需求，以更好地证明中低收入国家的价值主张。 (C) 2017 年作者。由爱思唯尔有限公司出版
In 2017, WHO convened a working group of global experts to develop the Preferred Product Characteristics (PPC) for Next-Generation Influenza Vaccines. PPCs are intended to encourage innovation in vaccine development. They describe WHO preferences for parameters of vaccines, in particular their indications, target groups, implementation strategies, and clinical data needed for assessment of safety and efficacy. PPCs are shaped by the global unmet public health need in a priority disease area for which WHO encourages vaccine development. These preferences reflect WHO's mandate to promote the development of vaccines with high public health impact and suitability in Low- and Middle-Income Countries (LMIC). The target audience is all entities intending to develop or to achieve widespread adoption of a specific influenza vaccine product in these settings. The working group determined that existing influenza vaccines are not well suited for LMIC use. While many developed country manufactures and research funders prioritize influenza vaccine products for use in adults and the elderly, most LMICs do not have sufficiently strong health systems to deliver vaccines to these groups. Policy makers from LMICs are expected to place higher value on vaccines indicated for prevention of severe illness, however the clinical development of influenza vaccines focuses on demonstrating prevention of any influenza illness. Many influenza vaccine products do not meet WHO standards for programmatic suitability of vaccines, which introduces challenges when vaccines are used in low-resource settings. And finally, current vaccines do not integrate well with routine immunization programs in LMICs, given age of vaccine licensure, arbitrary expiration dates timed for temperate country markets, and the need for year-round immunization in countries with prolonged influenza seasonality. While all interested parties should refer to the full PPC document for details, in this article we highlight data needs for new influenza vaccines to better demonstrate the value proposition in LMICs. (C) 2017 The Author(s). Published by Elsevier Ltd.