Tracking Canada's 2015 vaccine research and development priorities: Where are we a decade later?

Nasheed Moqueet, Kyle Lago, Serena Cortés-Kaplan, Harsimrat Birdi, Shalini Desai, Alisha Gauhar, Bryna Warshawsky, Matthew Tunis, Krista Wilkinson
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Abstract

Background: In 2015, Public Health Agency of Canada (PHAC) identified a set of priorities for research and development (R&D) of new and improved human and animal vaccines. Thirty human pathogens were grouped by vaccine development timeline (short: 0-6 years; medium: 7-12 years; long: 13 years or longer) and ranked by R&D priority (high, medium, low).

Objective: To characterize the vaccine development pathway for these 30 pathogens to inform a 2025 update to PHAC's vaccine R&D priorities.

Methods: For each pathogen, we conducted a targeted search for vaccines authorized in Canada since 2015 using the Health Canada Drug Product Database and Canadian Immunization Guide and for candidates in clinical trials, in the registry, ClinicalTrials.gov (primary completion date of May 1, 2015 or later). Search results were downloaded and filtered by study status, phase and type. For select pathogens, we conducted additional searches in published (PubMed) and grey literature (other trial registries, industry press releases, and Web searches).

Results: Seven pathogens had at least one newly authorized vaccine since 2015: three of 13 high-priority (influenza, n=4; Streptococcus pneumoniae, n=2; respiratory syncytial virus, n=3); two of eight medium-priority (herpes zoster, n=1; meningococcal serogroup B, n=1); and, two of nine low-priority pathogens (dengue, n=2; human papillomavirus, n=1). Nineteen pathogens had no authorized vaccine in Canada or elsewhere, although five had candidates in phase 3 trials (Clostridioides difficile, Neisseria gonorrhoeae, Borrelia burgdorferi, norovirus and cytomegalovirus).

Conclusion: Although some of the pathogens on the 2015 list now have authorized vaccines or candidates in late-stage clinical development, important gaps persist, which will inform PHAC's 2025 vaccine R&D update.

跟踪加拿大2015年疫苗研发重点:十年后我们在哪里?
背景:2015年,加拿大公共卫生署(PHAC)确定了一套新的和改进的人类和动物疫苗研发(R&D)的优先事项。按疫苗开发时间(短:0-6年;中:7-12年;长:13年或更长)对30种人类病原体进行分组,并按研发优先级(高、中、低)进行排序。目的:描述这30种病原体的疫苗开发途径,为2025年PHAC疫苗研发重点的更新提供信息。方法:针对每种病原体,我们使用加拿大卫生部药品数据库和加拿大免疫指南对2015年以来在加拿大批准的疫苗和临床试验候选疫苗进行了有针对性的搜索,在注册库ClinicalTrials.gov中(主要完成日期为2015年5月1日或更晚)。下载搜索结果并按研究状态、阶段和类型进行过滤。对于选定的病原体,我们在已发表的(PubMed)和灰色文献(其他试验注册、行业新闻稿和网络搜索)中进行了额外的搜索。结果:自2015年以来,7种病原体至少有一种新批准疫苗:13种高优先级病原体中有3种(流感,n=4;肺炎链球菌,n=2;呼吸道合胞病毒,n=3);8个中等优先级中的2个(带状疱疹,n=1;脑膜炎球菌血清B组,n=1);九种低优先级病原体中的两种(登革热,n=2;人乳头瘤病毒,n=1)。19种病原体在加拿大或其他地方没有批准的疫苗,尽管有5种候选疫苗正在进行3期试验(艰难梭菌、淋病奈瑟菌、伯氏疏螺旋体、诺如病毒和巨细胞病毒)。结论:尽管2015年清单上的一些病原体目前已获得批准的疫苗或处于后期临床开发阶段的候选疫苗,但重要的差距仍然存在,这将为PHAC 2025年疫苗研发更新提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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