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In a development with potentially far-reaching consequences, scientists funded by the Bill & Melinda Gates Foundation and U.S. National Institutes of Health (NIH) have created genetically modified mosquitoes designed to spread a synthetic gene through wild populations—and they intend to release them into the environment.
The study’s publication comes after researchers funded by the Bill & Melinda Gates Foundation created genetically modified mosquitoes that inject human subjects with engineered malaria-causing parasites—raising serious concerns about cardiac safety, informed consent, and the absence of long-term health data.
Published in Nature in 2025, the new NIH and Gates-backed study involves researchers from the University of California, Johns Hopkins University, and other institutions.
“Funding was provided by the Bill and Melinda Gates Foundation INV-036579 (to E.B.), INV-043645 (to G.D.), INV-017683 and INV-078535 (to J.M.M.); National Institutes of Health grants R01GM117321, R01GM144608, R01AI162911 (to E.B.), R01AI170692 and R01AI158615 (to G.D.) and R01AI143698 (to J.M.M.),” the study confirms.
The scientists used CRISPR-based gene editing to alter the genome of Anopheles stephensi, a major urban malaria vector, by modifying a single gene known as FREP1.
“We assessed possible fitness costs associated with the FREP1Q allele by quantifying the body size, fecundity and longevity of FREP1Q versus FREP1L mosquito strains (Fig. 2). We used wing length as a proxy for body size and vasa-Cas9 as an additional control, as the FREP1-transgenic lines were generated from the vasa-Cas9 strain.”
Cas9 is a protein that acts as a molecular “scissors” in the CRISPR/Cas9 gene-editing system.
CRISPR is a technology originally derived from a bacterial immune system that allows scientists to precisely cut and edit DNA at specific locations, enabling targeted gene modifications for research, medicine, and biotechnology applications.
The researchers’ goal was apparently to make the mosquitoes resistant to the malaria parasite.
But this isn’t just a one-time genetic tweak.
The researchers engineered a self-propagating “allelic drive” system—a gene drive designed to overwrite the natural version of the gene in every generation.
In lab conditions, the synthetic FREP1Q variant spread to over 90% of the mosquito population within just 10 generations.
The stated purpose is to combat malaria, a disease that continues to cause hundreds of thousands of deaths each year.
By introducing this synthetic gene, the researchers are aiming to render entire mosquito populations incapable of transmitting the parasite, by releasing them into the environment among the insects’ wild and “freely mating population.”
“On the basis of both the experimental data and in-depth supporting modelling, we conclude that the linked allelic-drive strategy described in this study can efficiently drive the preferred parasite refractory variant of the FREP1 locus into a freely mating population of mosquitoes and render them robustly refractory to parasite infection, providing a promising foundation for future application in vector control.”
But the consequences of releasing such mosquitoes into the environment, particularly among human populations, are far from fully understood.
One of the most concerning aspects of this project is the irreversible nature of the genetic alteration.
Once released, these mosquitoes are designed to mate with wild ones, spreading the synthetic gene through natural populations without any way to recall or contain it.
That raises serious questions about long-term ecological impacts, particularly if the engineered gene causes unintended effects.
While the FREP1Q mutation is claimed to be “fitness-neutral” in the lab—meaning the mosquitoes live and reproduce normally—researchers observed some differences in lifespan and fertility under certain conditions.
These could be early signs of subtle negative effects that might only fully emerge under the complex pressures of real-world ecosystems.
There’s also the matter of off-target effects.
Gene editing, especially when deployed at the scale of population-wide transformation, carries the risk of unexpected genetic disruptions.
FREP1 may have additional roles in mosquito physiology beyond facilitating malaria transmission.
Disrupting it could alter how mosquitoes interact with other microbes, respond to environmental stressors, or even open evolutionary doors for the malaria parasite to adapt in unforeseen ways.
Despite these risks, the Gates Foundation continues to back aggressive bioengineering efforts targeting mosquitoes, including previous support for gene drive projects under the banner of malaria control.
This latest project moves the world closer to the unsettling, deliberate release of self-editing organisms into ecosystems where people live, with the goal of permanent population-wide genetic change.
Whether this will be remembered as a public health triumph or a biological miscalculation remains to be seen.
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Author: Jon Fleetwood
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