Hasso-Agopsowicz Mateusz, Hwang Angela, Hollm-Delgado Maria-Graciela, Umbelino-Walker Isis, Karron Ruth A, Rao Raman, Asante Kwaku Poku, Sheel Meru, Sparrow Erin, Giersing Birgitte
World Health Organization, Geneva, Switzerland.
Bridges to Development, Geneva, Switzerland; Angela Hwang Consulting, Albany, CA, USA.
EBioMedicine. 2024 Dec;110:105424. doi: 10.1016/j.ebiom.2024.105424. Epub 2024 Nov 4.
To date, global priorities for new vaccine R&D have not been systematically identified for endemic pathogens. As part of Immunisation Agenda 2030 (IA2030), we have systematically identified priority endemic pathogens for new vaccine R&D based on country and regional stakeholder values to address this need.
MCDA surveys targeting policy makers and immunisation stakeholders in each World Health Organization (WHO) region were used to weight eight criteria for prioritisation. Applying those weights to regional pathogen data yielded regional top ten pathogen lists, which are intended to inform regional deliberations on R&D priorities. The regional top ten lists were combined into an IA2030 global priority list. To inform R&D, use cases for new vaccines and monoclonal antibodies were identified, then categorized in terms of the activities needed to accelerate progress.
In five out of six WHO regions, Annual deaths in children under five and Contribution to antimicrobial resistance were the most heavily weighted criteria. How participants weighted the criteria was not associated with their region, biographical characteristics, or areas of expertise. Five pathogens were common priorities across all regions: M tuberculosis, HIV-1, K pneumoniae, S aureus, and Extra-intestinal pathogenic E coli. Six pathogens were priorities in single regions. Combining regional top ten lists provided a global list of 17 priority pathogens for new vaccine R&D. Thirty-four distinct use cases were identified for new products targeting these pathogens. While most are in the "Advance product development" category, ten are in the "Research" category and seven are in the "Prepare to implement" category.
These priorities for new vaccine R&D will help stakeholders better respond to regional and country needs. The use cases will inform R&D and enable monitoring of R&D under IA2030.
The work was funded by a Bill and Melinda Gates Foundation grant to WHO (INV-005318).
迄今为止，尚未针对地方性病原体系统地确定新疫苗研发的全球优先事项。作为《2030年免疫议程》（IA2030）的一部分，我们基于国家和地区利益相关者的价值观，系统地确定了新疫苗研发的优先地方性病原体，以满足这一需求。
针对世界卫生组织（WHO）各区域的政策制定者和免疫利益相关者开展多标准决策分析（MCDA）调查，以权衡八个优先排序标准。将这些权重应用于区域病原体数据，得出区域十大病原体清单，旨在为有关研发优先事项的区域审议提供参考。区域十大清单合并为IA2030全球优先清单。为指导研发工作，确定了新疫苗和单克隆抗体的用例，然后根据加速进展所需的活动进行分类。
在WHO的六个区域中，有五个区域五岁以下儿童的年死亡人数和对抗菌素耐药性的影响是权重最高的标准。参与者对标准的加权方式与他们所在的区域、个人特征或专业领域无关。所有区域共有五种病原体是共同的优先事项：结核分枝杆菌、HIV-1、肺炎克雷伯菌、金黄色葡萄球菌和肠外致病性大肠杆菌。有六种病原体是单个区域的优先事项。合并区域十大清单得出了一份包含17种新疫苗研发优先病原体的全球清单。针对这些病原体的新产品确定了34个不同的用例。虽然大多数属于“推进产品开发”类别，但有10个属于“研究”类别，7个属于“准备实施”类别。
这些新疫苗研发的优先事项将有助于利益相关者更好地应对区域和国家需求。这些用例将为研发提供指导，并有助于在IA2030下监测研发工作。
这项工作由比尔及梅琳达·盖茨基金会向WHO提供的赠款（INV-005318）资助。
