2021 WHO guidelines on genetically modified mosquitoes
Authors: Munyaradzi Makoni
Journal: The Lancet Microbe (2021)

On May 19, 2021, WHO updated its guidelines for research and development on genetically modified mosquitoes, which define the standards for decision-making about how and when testing should proceed and describe best practices to ensure that research done in a public health context is safe, ethical, and rigorous. TDR, WHO's Special Programme for Research and Training in Tropical Diseases, and the GeneConvene Global Collaborative, an initiative of the Foundation for the National Institutes of Health, developed the updated guidelines building on the 2014 recommendations, integrating the latest advancements in mosquito genetic modification. “Vector-borne diseases are a major global public health issue. Over 100 countries are endemic for diseases such as dengue, malaria, and Zika. Dengue alone puts 2·5 billion people at risk”, says John Reeder (TDR and Department of Research for Health, WHO). Attacking the mosquitoes is an effective way of controlling the transmission of these diseases, but it is a massive task. “We are badly in need of new technologies that will change the game and allow effective, widespread control”, Reeder told The Lancet Microbe. Genetic engineering of mosquitoes has the potential of bringing state-of-the-art scientific tools into the service of global health; however, the full effects of release into the environment is unknown. Concerns about the potential environmental and health impact of deploying such technologies also arise among the general public. “So how do we reconcile technological advance with public concern and safety? This is the heart of the new guidance from the WHO”, Reeder says. “The key message is not to fear new science, but to understand the issues associated with it and provide responsible governance that tests the technology in a controlled and safe manner.” The guidance draws on multiple disciplines to inform researchers, affected communities, and other stakeholders about how to responsibly test genetically modified mosquitoes, says Michael Santos (GeneConvene, FNIH). “The essential considerations are evaluation of public health and safety and the ethical responsibilities to different stakeholder groups”, he adds. Small-scale releases of an early version of genetically modified mosquitoes for population suppression were tested by Oxitec (Abingdon, UK) in 2014. In 2021, second-generation, genetically modified, fertile males intended to extend the duration of the suppression of the local mosquito population were released in Florida (USA), although introduced males will eventually disappear. Target Malaria has done a small, single-field release of a male sterile version of their technology in Burkina Faso, in 2019. Colince Kamdem (Centre for Research in Infectious Diseases, Yaoundé, Cameroon), says the new guidelines are “an excellent roadmap that will help address some of the concerns, which are likely to undermine the successful deployment of genetically modified mosquitoes in malaria vector control”. “Often the risk question is raised among the stakeholders and they want to know how […] to address these questions. Having a guideline document will [contribute to] the discussion”, says Lea Toe (Target Malaria), adding “We work closely with communities at research sites to involve them in mosquito collection and the release process”. “Stakeholder engagement is essential to responsible and effective research and research oversight because it provides insights into the true unmet needs and the concerns to be addressed”, says Santos, adding that “updated guidance reflects recent advances in how to implement ethical stakeholder engagement, including as part of risk assessments”. Despite their importance, the WHO guidelines alone are not designed to address all fears, says Kamdem. “This outreach effort should start within the research community itself, which remains highly divided with regard to the necessity and safety of releasing transgenic mosquitoes in nature”, he told The Lancet Microbe. Calls from several international governance bodies asking for public and local community engagement for genetically modified mosquito projects have gone unnoticed, but what is lacking are standards for engagement and consent, says Natalie Kofler (Editing Nature and Scientific Citizenship Initiative, Harvard Medical School, Cambridge, MA, USA). For example, she explains, in some cases, the line between community engagement and marketing gets blurry. “Along those same lines, most community engagement is driven by the technology developers themselves. This creates a conflict of interest”, Kofler told The Lancet Microbe. In 2017, Kofler and colleagues wrote in Science calling for creation of neutral, balanced spaces for community members to be informed, voice concerns, and steer research and decisions of deployment for genetically modified mosquitoes. “It's important that the WHO clearly states the need for community engagement, but the how is really important and I worry that community engagement is becoming just another box to be checked by developers”, she says. “Communities need to be part of co-creating the solutions for problems they face. And good community partnerships take a lot of time, money, and relationship-building, needs that don’t always align with the innovation enterprise.” For more on WHO's updated guidelines see https://www.who.int/publications/i/item/9789240025233For TDR see https://tdr.who.int/For GeneConvene Global Collaborative see https://fnih.org/our-programs/geneconveneFor more on the 2021 release of genetically modified mosquitoes in Florida see https://www.nature.com/articles/d41586-021-01186-6For Target Malaria see https://targetmalaria.org/For Editing Nature see https://www.editingnature.org/For more on community engagement for genetically modified mosquito release see Science 2017; 362: 527–29 For more on WHO's updated guidelines see https://www.who.int/publications/i/item/9789240025233 For TDR see https://tdr.who.int/ For GeneConvene Global Collaborative see https://fnih.org/our-programs/geneconvene For more on the 2021 release of genetically modified mosquitoes in Florida see https://www.nature.com/articles/d41586-021-01186-6 For Target Malaria see https://targetmalaria.org/ For Editing Nature see https://www.editingnature.org/ For more on community engagement for genetically modified mosquito release see Science 2017; 362: 527–29