Problem formulation consultations for gene drive mosquitoes designed to reduce malaria transmission in Africa.
The FNIH provided facilitation support to The New Partnership for Africa’s Development (NEPAD, now the African Union Development Agency [AUDA-NEPAD]) for four regional problem formulation workshops on the African continent bringing together representatives from regional biosafety and health regulatory authorities to discuss the concept of gene drive mosquitoes as a public health tool for reducing transmission of vector borne diseases.
Problem formulation identifies the values for which risks should be considered, sometimes called protection goals, and identifies hazards that could present risks to those values. This lays the groundwork for subsequent characterization and evaluation of the risks. Participants at these workshops were presented with background information on mosquito biology, ecology and role in malaria transmission, as well as technical information on genetic engineering and gene drive function. In addition, participants undertook an exercise in identifying potential hazards associated with this research and held discussions on the applicability of regional harmonization in evaluating this technology.
The FNIH aims to ensure impartial oversight of research on genetically modified mosquitoes through support of risk assessments conducted by qualified experts having no vested interest in the success of the product.
Risk assessments commissioned to date:
Risk Assessment for Controlling Mosquito Vectors with Engineered Nucleases: Sterile Male Construct final report
In 2015, the FNIH supported development and publication of a risk assessment for confined use of a sterile male strain of Anopheles gambiae mosquitoes at sites in Africa. These are genetically modified mosquitoes but do not contain gene drive technology. This risk assessment was conducted through a partnership with Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO).
Risk Assessment for Controlled Mosquito Vectors with Engineered Nucleases: Contained field release for Sterile Male Construct Risk assessment final report
In 2018, the FNIH supported conduct by CSIRO of an independent risk assessment for a small-scale field release of a sterile male strain of Anopheles coluzzii.
Scoping Documents for Risk Assessments
Structured prioritization of human and animal pathogens.
In conducting risk assessments of genetically modified mosquitoes, a commonly encountered concern is whether the modification will increase their potential to transmit non-target pathogens. FNIH commissioned a structured two-step study by Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) to systematically determine all possible human and livestock pathogens that could be transmitted by Anopheles gambiae mosquitoes in Africa, followed by prioritization of those pathogens with evidence of transmission by Anopheles gambiae mosquitoes in Africa based on features commonly used to rank communicable and emerging diseases. This study was undertaken to assist the scoping and support of risk assessment related data collection.
Results from the workshop “Problem Formulation for the Use of Gene Drive in Mosquitoes.”
Am. J. Trop. Med. Hyg., 96(3):530-533,2017. doi: 10.4269/ajtmh.16-0726 The FNIH hosted a problem formulation workshop in 2016 with global scientific and regulatory experts to systematically evaluate the potential risks associated with the use of gene drive mosquitoes intended to reduce the burden of malaria in Africa.
Problem formulation identifies the values for which risks be considered, sometimes called protection goals, and identifies hazards that could present risks to those values. This lays the groundwork for subsequent characterization and evaluation of the risks. During this workshop, participants undertook a systematic problem formulation exercise, focusing on gene drive mosquitoes as a method for control of the malaria vector Anopheles gambiae in sub-Saharan Africa. Participants discussed how relevant protection goals and hazards may help to inform risk assessments of investigational gene drive organisms, the design of gene drive research and future guidelines and regulations on the use of the technology.