Wolfe Daniel N, Sabourin Carol L, Merchlinsky Michael J, Florence William C, Wolfraim Larry A, Taylor Kimberly L, Ward Lucy A
U.S. Department of Health and Human Services (DHHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Washington, DC 20201, USA.
Tunnell Government Services, Inc., Supporting Biomedical Advanced Research & Development Authority (BARDA), Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (DHHS), Washington, DC 20201, USA.
Vaccines (Basel). 2021 Sep 19;9(9):1045. doi: 10.3390/vaccines9091045.
The continuing outbreaks of ebola virus disease highlight the ongoing threat posed by filoviruses. Fortunately, licensed vaccines and therapeutics are now available for . However, effective medical countermeasures, such as vaccines for other filoviruses such as and the Marburg virus, are presently in early stages of development and, in the absence of a large outbreak, would require regulatory approval via the U.S. Food and Drug Administration (FDA) Animal Rule. The selection of an appropriate animal model and virus challenge isolates for nonclinical studies are critical aspects of the development program. Here, we have focused on the recommendation of challenge isolates for and Marburg virus. Based on analyses led by the Filovirus Animal and Nonclinical Group (FANG) and considerations for strain selection under the FDA Guidance for the Animal Rule, we propose prototype virus isolates for use in nonclinical challenge studies.
埃博拉病毒病的持续爆发凸显了丝状病毒带来的持续威胁。幸运的是，目前已有针对该病毒的许可疫苗和治疗方法。然而，针对其他丝状病毒（如拉沙病毒和马尔堡病毒）的有效医学应对措施目前正处于早期研发阶段，并且在没有大规模疫情爆发的情况下，需要通过美国食品药品监督管理局（FDA）动物规则获得监管批准。选择合适的动物模型和病毒攻击分离株用于非临床研究是研发计划的关键环节。在此，我们重点关注了拉沙病毒和马尔堡病毒攻击分离株的推荐。基于丝状病毒动物和非临床小组（FANG）主导的分析以及FDA动物规则指南下的毒株选择考量，我们提出了用于非临床攻击研究的原型病毒分离株。
