期刊
VIRUSES-BASEL
卷 14, 期 12, 页码 -出版社
MDPI
DOI: 10.3390/v14122619
关键词
African Swine Fever; harmonized guidelines; modified-live vaccine; regulatory; standards; World Organisation for Animal Health
类别
资金
- CRDF Global
- [PO22-00179]
The recent centennial anniversary of R.E. Montgomery's published description of swine fever disease transmission highlights the importance of accelerating African Swine Fever (ASF) vaccine research. Modified live virus (MLV) vaccine candidates offer the most promise, but the lack of internationally harmonized standards for assessing vaccine quality is a major impediment. The establishment of international guidelines by the World Organisation for Animal Health (WOAH) is crucial for successful regulatory development and approval of ASF MLV vaccines.
The recent centennial anniversary of R.E. Montgomery's seminal published description of a form of swine fever disease transmitted from wild African pigs to European domestic pigs is a call to action to accelerate African Swine Fever (ASF) vaccine research and development. ASF modified live virus (MLV) first-generation gene deleted vaccine candidates currently offer the most promise to meet international and national guidelines and regulatory requirements for veterinary product licensure and market authorization. A major, rate-limiting impediment to the acceleration of current as well as future vaccine candidates into regulatory development is the absence of internationally harmonized standards for assessing vaccine purity, potency, safety, and efficacy. This review summarizes the asymmetrical landscape of peer-reviewed published literature on ASF MLV vaccine approaches and lead candidates, primarily studied to date in the research laboratory in proof-of-concept or early feasibility clinical safety and efficacy studies. Initial recommendations are offered toward eventual consensus of international harmonized guidelines and standards for ASF MLV vaccine purity, potency, safety, and efficacy. To help ensure the successful regulatory development and approval of ASF MLV first generation vaccines by national regulatory associated government agencies, the World Organisation for Animal Health (WOAH) establishment and publication of harmonized international guidelines is paramount.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据