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推进基因驱动改良蚊子进行田间试验的功效和安全标准的定义。

Toward the Definition of Efficacy and Safety Criteria for Advancing Gene Drive-Modified Mosquitoes to Field Testing.

机构信息

Foundation for the National Institutes of Health, North Bethesda, Maryland.

University of California Berkeley, Berkeley, California.

出版信息

Vector Borne Zoonotic Dis. 2020 Apr;20(4):237-251. doi: 10.1089/vbz.2019.2606. Epub 2020 Mar 9.

Abstract

Mosquitoes containing gene drive systems are being developed as complementary tools to prevent transmission of malaria and other mosquito-borne diseases. As with any new tool, decision makers and other stakeholders will need to balance risks (safety) and benefits (efficacy) when considering the rationale for testing and deploying gene drive-modified mosquito products. Developers will benefit from standards for judging whether an investigational gene drive product meets acceptability criteria for advancing to field trials. Such standards may be formalized as preferred product characteristics and target product profiles, which describe the desired attributes of the product category and of a particular product, respectively. This report summarizes discussions from two scientific workshops aimed at identifying efficacy and safety characteristics that must be minimally met for an investigational gene drive-modified mosquito product to be deemed viable to move from contained testing to field release and the data that will be needed to support an application for first field release.

摘要

正在开发携带基因驱动系统的蚊子,作为预防疟疾和其他蚊媒疾病传播的补充工具。与任何新工具一样,决策者和其他利益相关者在考虑测试和部署基因驱动改良蚊子产品的理由时,需要权衡风险(安全性)和收益(功效)。开发商将从评判标准中受益,这些标准用于判断研究性基因驱动产品是否符合推进现场试验的可接受标准。这些标准可以形式化为首选产品特性和目标产品特征,分别描述产品类别和特定产品的理想属性。本报告总结了两个科学研讨会的讨论,目的是确定研究性基因驱动改良蚊子产品必须满足的功效和安全性特征,以使其有资格从受控测试转移到现场释放,并确定支持首次现场释放申请所需的数据。

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