ILAR J. 2022 Jan 7;61(1):46-61. doi: 10.1093/ilar/ilab004.
New solutions are necessary for the singular global health security threat formed by endemic, epidemic, and emerging/re-emerging zoonoses, coupled with epizootic and enzootic transboundary animal diseases (TADs). This One Health issue is related to the daily interactions between wildlife, domesticated and indigenous livestock, and humans primarily associated with global trade, transboundary co-movement of humans and diverse livestock/livestock products, and agriculture production intensification and penetration into previously uninhabited areas. The World Health Organization defines Risk Group 3 (RG-3) and RG-4 pathogens as mainly viruses but also bacteria that serve as the foundation for approximately 60% of emerging infectious diseases that are zoonoses. The World Organisation for Animal Health defines trade-notifiable TADs, and subsets of these are zoonotic. Livestock vaccination policies mainly focus on TADs that are promulgated by the United Nations Food and Agriculture Organization and government agriculture agencies. The development, licensure, and product manufacturing of next-generation molecular-based RG-3 and RG-4 veterinary vaccines largely ignored by the global animal health biopharmaceutical sector can have an important positive impact on food security and One Health. There have been sharp increases in the global demand for livestock meat and milk products, especially in low- and middle-income countries in Africa and Asia. This relatively recent market driver-coupled with scientific advances in human EID and zoonotic disease vaccine platform technologies and increases in the number of high (US biosafety level 3 agriculture) and maximum (US animal biosafety level 4) biocontainment facilities with supporting workforce capabilities-offers new investment opportunities to the animal health biopharmaceutical sector. Moreover, a growing number of One Health public-private partnerships have moved the net present value calculus in favor of the financial feasibility of RG-3 and RG-4 veterinary vaccine product development and licensure. This article highlights the challenges and opportunities in the use of high and maximum biocontainment facilities in developing and licensing RG-3 and RG-4 veterinary vaccines that are safe and effective against epizootic and enzootic TADs and zoonotic diseases.
对于由地方性、流行性和新出现/再现的人畜共患病以及动物疫病的流行和地方性流行所构成的独特的全球卫生安全威胁，需要有新的解决方案。这个“同一健康”问题与野生动物、家养和本地牲畜以及人类之间的日常互动有关，主要与全球贸易、人类和各种牲畜/牲畜产品的跨界共同流动以及农业生产集约化和向以前无人居住的地区渗透有关。世界卫生组织将风险组 3（RG-3）和 RG-4 病原体定义为主要是病毒，但也包括细菌，这些病原体构成了大约 60%的人畜共患新发传染病的基础。世界动物卫生组织定义了贸易通报的动物疫病，其中一些子集是人畜共患病。牲畜疫苗接种政策主要侧重于由联合国粮食及农业组织和政府农业机构发布的动物疫病。新一代基于分子的 RG-3 和 RG-4 兽医疫苗的开发、许可和产品制造在全球动物健康生物制药行业中基本上被忽视，但对食品安全和同一健康具有重要的积极影响。全球对牲畜肉类和奶制品的需求急剧增加，特别是在非洲和亚洲的低收入和中等收入国家。这种相对较新的市场驱动力，加上人类新发传染病和人畜共患病疫苗平台技术的进步以及高（美国生物安全 3 级农业）和最高（美国动物生物安全 4 级）生物遏制设施数量的增加，为动物健康生物制药行业提供了新的投资机会。此外，越来越多的同一健康公私伙伴关系使得净现值计算有利于 RG-3 和 RG-4 兽医疫苗产品开发和许可的财务可行性。本文重点介绍了在开发和许可针对流行和地方性动物疫病以及人畜共患病的安全有效的 RG-3 和 RG-4 兽医疫苗时使用高和最高生物遏制设施所面临的挑战和机遇。
